CompletedNCT01031069Updated Jul 21, 2020Results posted

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

A Phase 4 interventional study of GSK Biologicals' HPV vaccine 580299 and Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil) in Infections, Papillomavirus and Papillomavirus Vaccines, sponsored by GlaxoSmithKline. Completed at 15 sites in 4 countries. Open to female participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 873
Allocation: Randomized
Ages: 15 Years to 25 Years
Sex: Female

Study summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6).

Conditions studied

Infections, Papillomavirus
Papillomavirus Vaccines

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Keywords

Cervarix
Gardasil
Immunogenicity
Cervical cancer
Safety
HPV vaccine

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 873 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 15 Years to 25 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol.
A female between, and including, 15 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject and/or from the subject's parent or LAR.
Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status.
For HIV seropositive subjects:
- Subjects must be HIV seropositive according to World Health Organization (WHO) case definition.
- Subject must be asymptomatic (or only have persistent generalized lymphadenopathy).
- Subjects should have a CD4 cell count > 350 cells/mm3.
- If currently taking antiretrovirals (ARVs), subjects must be on compliant to triple therapy (highly active ART) and have undetectable viral load on two previous clinical visits within the six months prior to study entry.
For HIV seronegative subjects:
- Subjects confirmed as HIV seronegative at the screening visit.
For non-virgin female subjects:
- Subjects must have no history of abnormal cytology or CIN 1/2/3.
- Subjects must have had no more than six life-time sexual partners prior to enrollment.
Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures involving damage to the transformation zone of the cervix or stenosis.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test at screening and on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion criteria

Exclusion Criteria:

Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 24).
ART not compliant with the National Guidelines.
Active tuberculosis (TB) visit (criteria mandatory only for HIV+ subjects).
Current TB therapy.
Hemoglobin \< 8.0 g/dL at the screening visit.
Creatinine > 1.5-fold the upper limit of normal (ULN) at the screening visit.
Alanine aminotransferase (ALT) > 2.5-fold ULN at the screening visit.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (Day 0 to Month 24).
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs (with the exception of ART) within six months prior to the first vaccine dose.
Administration of a vaccine not foreseen by the study protocol within 30 days (Days 0 - 29) before the first dose of study vaccine/control. Enrollment will be postponed until the subject is outside the specified window.
Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0 - 29) any dose of study vaccine.
Previous administration of components of the investigational vaccine.
Cancer or autoimmune disease under treatment.
Hypersensitivity to latex.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.
Acute disease and/or fever at the time of enrollment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
History of any neurological disorders or seizures.
Pregnant or breastfeeding female.
A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e., up to Month 8).
Concurrently participating in another clinical study, at any time during the study period (Day 0 to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product.
Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrollment will be postponed until the subject is outside the specified window.
Administration of trimethoprim/sulphamethoxazole within seven days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within seven days after the first dose of study vaccine/control.
Current drugs or alcohol abuse.
Child in care.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 873 participants (actual)

Study arms

Experimental
HIV+/Cervarix Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
Biological: GSK Biologicals' HPV vaccine 580299
Active comparator
HIV+/Gardasil Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
Experimental
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
Biological: GSK Biologicals' HPV vaccine 580299
Active comparator
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)

Interventions

BiologicalGSK Biologicals' HPV vaccine 580299
Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Also known as: Cervarix
BiologicalMerck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Also known as: Gardasil

What researchers measure

Primary outcomes

Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
Time frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, rash, temperature \[defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
Number of HIV+ Subjects With Serious Adverse Events (SAEs)
SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of HIV+ Subjects With Medically Significant Conditions (MSCs)
Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophilis \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\], haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\], monocytes \[MONO\], neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7
CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)
HIV Viral Load (VL) in HIV+ Subjects at Month 7
HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)
Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity
Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects. Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)
Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)

Secondary outcomes

Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
Time frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, rash, temperature \[defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Number of HIV- Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
Number of HIV- Subjects With Serious Adverse Events (SAEs)
SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of HIV- Subjects With Medically Significant Conditions (MSCs)
Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)
Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.
Time frame: During the entire study period (from Day 0 up to Month 24)
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophils \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
Among assessed haematological parameters were: haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\] and monocytes \[MONO\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
Among assessed haematological parameters were: neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
Number of Subjects With SAEs
SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period (from Day 0 up to Month 24)
Number of Subjects With Medically Significant Conditions (MSCs)
Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
Time frame: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24
CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
Time frame: At Months 12, 18 and 24
HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24
HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.
Time frame: At Months 12, 18 and 24
Number of HIV+ Subjects by WHO HIV Clinical Staging
HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].
Time frame: At Months 12, 18 and 24
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC
Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], for HIV- subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).
Time frame: At Month 7 (30 days after the last vaccination dose at Month 6)
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.
Time frame: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.
Time frame: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
Frequency of Specific B-cells for HPV-16/18 Antigens
B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
Time frame: At Day 0, Week 6, Week 10, Month 7 and Month 12
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
Time frame: At Day 0, Week 6, Week 10, Month 7 and Month 12

Results

Posted Jul 24, 2019

Participant flow

A number of 873 subjects were enrolled, out of which 173 subjects were excluded from all statistical analysis. 154 subjects were not administered any vaccine dose (146 screen failures subjects and 8 subjects that did not participate from Visit 1).

Participant flow — Overall Study
Milestone	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
Started	129	128	144	145
Completed	117	117	103	111
Not completed	12	11	41	34
Withdrew: Serious adverse event	0	1	0	0
Withdrew: Withdrawal by subject	2	3	18	18
Withdrew: Migrated/moved from study area	1	2	1	1
Withdrew: Lost to follow-up	9	5	21	15
Withdrew: Other	0	0	1	0

Outcome measures

PrimaryNumber of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).

Time frame:: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Reported as:: Count of participants · Participants

Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Any Pain, Dose 1	115	58
Grade 3 Pain, Dose 1	4	0
Any Redness, Dose 1	24	19
Grade 3 Redness, Dose 1	0	0
Any Swelling, Dose 1	25	6
Grade 3 Swelling, Dose 1	2	0
Any Pain, Dose 2	98	56
Grade 3 Pain, Dose 2	5	6
Any Redness, Dose 2	18	13
Grade 3 Redness, Dose 2	1	0
Any Swelling, Dose 2	16	11
Grade 3 Swelling, Dose 2	0	0
Any Pain, Dose 3	87	60
Grade 3 Pain, Dose 3	5	2
Any Redness, Dose 3	17	18
Grade 3 Redness, Dose 3	0	0
Any Swelling, Dose 3	19	10
Grade 3 Swelling, Dose 3	1	0
Any Pain, Across Doses	120	85
Grade 3 Pain, Across Doses	11	6
Any Redness, Across Doses	41	34
Grade 3 Redness, Across Doses	1	0
Any Swelling, Across Doses	38	20
Grade 3 Swelling, Across Doses	2	0

PrimaryNumber of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, rash, temperature \[defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Reported as:: Count of participants · Participants

Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Any Arthralgia, Dose 1	29	20
Grade 3 Arthralgia, Dose 1	1	1
Related Arthralgia, Dose 1	19	13
Any Fatigue, Dose 1	50	47
Grade 3 Fatigue, Dose 1	4	0
Related Fatigue, Dose 1	30	29
Any Gastrointestinal, Dose 1	30	21
Grade 3 Gastrointestinal, Dose 1	2	0
Related Gastrointestinal, Dose 1	19	15
Any Headache, Dose 1	61	48
Grade 3 Headache, Dose 1	4	1
Related Headache, Dose 1	39	27
Any Myalgia, Dose 1	49	34
Grade 3 Myalgia, Dose 1	2	1
Related Myalgia, Dose 1	35	25
Any Rash, Dose 1	7	4
Grade 3 Rash, Dose 1	1	0
Related Rash, Dose 1	4	0
Any Temperature, Dose 1	9	5
Grade 3 Temperature, Dose 1	0	0
Related Temperature, Dose 1	7	4
Any Urticaria, Dose 1	8	3
Grade 3 Urticaria, Dose 1	0	0
Related Urticaria, Dose 1	6	3
Any Arthralgia, Dose 2	18	21
Grade 3 Arthralgia, Dose 2	0	3
Related Arthralgia, Dose 2	11	14
Any Fatigue, Dose 2	38	40
Grade 3 Fatigue, Dose 2	2	1
Related Fatigue, Dose 2	20	25
Any Gastrointestinal, Dose 2	15	17
Grade 3 Gastrointestinal, Dose 2	0	0
Related Gastrointestinal, Dose 2	11	11
Any Headache, Dose 2	48	37
Grade 3 Headache, Dose 2	5	3
Related Headache, Dose 2	30	20
Any Myalgia, Dose 2	36	26
Grade 3 Myalgia, Dose 2	2	4
Related Myalgia, Dose 2	25	19
Any Rash, Dose 2	2	1
Grade 3 Rash, Dose 2	0	0
Related Rash, Dose 2	0	0
Any Temperature, Dose 2	11	4
Grade 3 Temperature, Dose 2	0	0
Related Temperature, Dose 2	9	2
Any Urticaria, Dose 2	5	4
Grade 3 Urticaria, Dose 2	1	0
Related Urticaria, Dose 2	4	4
Any Arthralgia, Dose 3	17	15
Grade 3 Arthralgia, Dose 3	2	1
Related Arthralgia, Dose 3	13	12
Any Fatigue, Dose 3	40	31
Grade 3 Fatigue, Dose 3	1	1
Related Fatigue, Dose 3	30	22
Any Gastrointestinal, Dose 3	13	17
Grade 3 Gastrointestinal, Dose 3	1	1
Related Gastrointestinal, Dose 3	9	13
Any Headache, Dose 3	48	27
Grade 3 Headache, Dose 3	2	2
Related Headache, Dose 3	39	16
Any Myalgia, Dose 3	30	21
Grade 3 Myalgia, Dose 3	4	1
Related Myalgia, Dose 3	26	17
Any Rash, Dose 3	2	1
Grade 3 Rash, Dose 3	0	0
Related Rash, Dose 3	1	0
Any Temperature, Dose 3	10	12
Grade 3 Temperature, Dose 3	1	1
Related Temperature, Dose 3	7	6
Any Urticaria, Dose 3	2	4
Grade 3 Urticaria, Dose 3	0	0
Related Urticaria, Dose 3	2	2
Any Arthralgia, Across Doses	41	38
Grade 3 Arthralgia, Across Doses	3	4
Related Arthralgia, Across Doses	31	28
Any Fatigue, Across Doses	73	59
Grade 3 Fatigue, Across Doses	6	2
Related Fatigue, Across Doses	50	39
Any Gastrointestinal, Across Doses	41	35
Grade 3 Gastrointestinal, Across Doses	3	1
Related Gastrointestinal, Across Doses	27	23
Any Headache, Across Doses	88	63
Grade 3 Headache, Across Doses	11	4
Related Headache, Across Doses	65	39
Any Myalgia, Across Doses	68	51
Grade 3 Myalgia, Across Doses	7	4
Related Myalgia, Across Doses	52	37
Any Rash, Across Doses	11	5
Grade 3 Rash, Across Doses	1	0
Related Rash, Across Doses	5	0
Any Temperature, Across Doses	23	19
Grade 3 Temperature, Across Doses	1	1
Related Temperature, Across Doses	18	10
Any Urticaria, Across Doses	13	9
Grade 3 Urticaria, Across Doses	1	0
Related Urticaria, Across Doses	10	8

PrimaryNumber of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
Reported as:: Count of participants · Participants

Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Any AE(s)	41	41
Grade 3 AE(s)	7	4
Related AE(s)	9	8

PrimaryNumber of HIV+ Subjects With Serious Adverse Events (SAEs)

SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV+ Subjects With Serious Adverse Events (SAEs)
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Number of HIV+ Subjects With Serious Adverse Events (SAEs)	6	6

PrimaryNumber of HIV+ Subjects With Medically Significant Conditions (MSCs)

Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV+ Subjects With Medically Significant Conditions (MSCs)
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Number of HIV+ Subjects With Medically Significant Conditions (MSCs)	17	27

PrimaryNumber of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)

Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)	1	0

PrimaryNumber of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Live infant NO apparent congenital anomaly	3	1
Live infant congenital anomaly	0	0
Elective termin. NO apparent congenital anomaly	0	0
Elective termin. congenital anomaly	0	0
Ectopic pregnancy	0	0
Spontaneous abortion NO apparent congen. anomaly	1	1
Stillbirth NO apparent congenital anomaly	0	0
Stillbirth congenital anomaly	0	0
Lost to follow-up	0	0
Pregnancy ongoing	0	0
Missing	0	0

PrimaryNumber of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities

Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophilis \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\], haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\], monocytes \[MONO\], neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
ALAT, Unknown	0	0
ALAT, Below	4	3
ALAT, Within	110	105
ALAT, Above	7	13
BSPH, Unknown	0	0
BSPH, Below	0	0
BSPH, Within	120	121
BSPH, Above	1	0
CRT, Unknown	0	0
CRT, Below	29	36
CRT, Within	91	84
CRT, Above	1	0
ESPH, Unknown	0	0
ESPH, Below	9	10
ESPH, Within	108	106
ESPH, Above	4	5
HTCR, Unknown	0	0
HTCR, Below	19	27
HTCR, Within	101	92
HTCR, Above	1	2
HGB, Unknown	0	0
HGB, Below	28	37
HGB, Within	92	83
HGB, Above	1	1
LYMP, Unknown	0	0
LYMP, Below	12	11
LYMP, Within	96	97
LYMP, Above	13	13
MONO, Unknown	0	0
MONO, Below	4	7
MONO, Within	106	97
MONO, Above	11	17
NTPH, Unknown	0	0
NTPH, Below	16	17
NTPH, Within	97	93
NTPH, Above	8	11
PLAT, Unknown	0	0
PLAT, Below	1	3
PLAT, Within	118	114
PLAT, Above	2	4
RBC, Unknown	0	0
RBC, Below	36	34
RBC, Within	82	84
RBC, Above	3	3
WBC, Unknown	0	0
WBC, Below	10	9
WBC, Within	106	108
WBC, Above	5	4

PrimaryCluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7

CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Median · cells/mm3

Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7
cells/mm3	HIV+/Cervarix Group	HIV+/Gardasil Group
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7	554.0 (440.0 to 799.0)	568.0 (457.0 to 773.4)

PrimaryHIV Viral Load (VL) in HIV+ Subjects at Month 7

HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Median · HIV copies/mL

HIV Viral Load (VL) in HIV+ Subjects at Month 7
HIV copies/mL	HIV+/Cervarix Group	HIV+/Gardasil Group
HIV Viral Load (VL) in HIV+ Subjects at Month 7	1.9 (1.3 to 3.8)	2.5 (1.3 to 3.8)

PrimaryNumber of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging

HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Clinical Stage 1	113	114
Clinical Stage 2	6	2
Clinical Stage 3	1	1
Clinical Stage 4	1	4

PrimaryPseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects. Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Geometric mean · Titers

Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity
Titers	HIV+/Cervarix Group	HIV+/Gardasil Group
Anti-HPV-16	23436.1 (18186.4 to 30201.1)	7507.0 (5378.1 to 10478.6)
Anti-HPV-18	12490.9 (9681.7 to 16115.2)	1459.6 (965.4 to 2206.7)

Statistical analysis

HIV+/Cervarix Group vs HIV+/Gardasil Group · Adjusted gmt ratio: 2.95 · 95% CI 1.92 to 4.52
HIV+/Cervarix Group vs HIV+/Gardasil Group · Adjusted gmt ratio: 7.83 · 95% CI 4.84 to 12.66

PrimaryPseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Geometric mean · Titers

Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)
Titers	HIV+/Cervarix Group	HIV+/Gardasil Group
Anti-HPV-16	21106.6 (15961.3 to 27910.6)	7533.7 (5616.7 to 10105.0)
Anti-HPV-18	11580.5 (8851.5 to 15150.9)	1451.9 (1009.0 to 2089.2)

Statistical analysis

HIV+/Cervarix Group vs HIV+/Gardasil Group · ANOVA · p = <0.0001 · Adjusted gmt ratio: 7.44 · 95% CI 4.79 to 11.54ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.
HIV+/Cervarix Group vs HIV+/Gardasil Group · ANOVA · p = <0.0001 · Adjusted gmt ratio: 2.74 · 95% CI 1.83 to 4.11ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.

SecondaryNumber of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame:: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Reported as:: Count of participants · Participants

Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Participants	HIV-/Cervarix Group	HIV-/Gardasil Group
Any Pain, Dose 1	127	91
Grade 3 Pain, Dose 1	10	1
Any Redness, Dose 1	32	21
Grade 3 Redness, Dose 1	0	0
Any Swelling, Dose 1	23	14
Grade 3 Swelling, Dose 1	0	0
Any Pain, Dose 2	108	92
Grade 3 Pain, Dose 2	6	2
Any Redness, Dose 2	29	29
Grade 3 Redness, Dose 2	0	0
Any Swelling, Dose 2	24	27
Grade 3 Swelling, Dose 2	0	0
Any Pain, Dose 3	94	82
Grade 3 Pain, Dose 3	10	6
Any Redness, Dose 3	28	19
Grade 3 Redness, Dose 3	0	0
Any Swelling, Dose 3	29	19
Grade 3 Swelling, Dose 3	0	0
Any Pain, Across Doses	133	119
Grade 3 Pain, Across Doses	22	8
Any Redness, Across Doses	52	42
Grade 3 Redness, Across Doses	0	0
Any Swelling, Across Doses	47	39
Grade 3 Swelling, Across Doses	0	0

SecondaryNumber of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms

Time frame:: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Reported as:: Count of participants · Participants

Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Participants	HIV-/Cervarix Group	HIV-/Gardasil Group
Any Arthralgia, Dose 1	17	21
Grade 3 Arthralgia, Dose 1	0	0
Related Arthralgia, Dose 1	9	11
Any Fatigue, Dose 1	45	34
Grade 3 Fatigue, Dose 1	3	2
Related Fatigue, Dose 1	29	17
Any Gastrointestinal, Dose 1	19	14
Grade 3 Gastrointestinal, Dose 1	1	1
Related Gastrointestinal, Dose 1	8	11
Any Headache, Dose 1	45	45
Grade 3 Headache, Dose 1	0	2
Related Headache, Dose 1	29	22
Any Myalgia, Dose 1	44	36
Grade 3 Myalgia, Dose 1	1	2
Related Myalgia, Dose 1	28	21
Any Rash, Dose 1	2	6
Grade 3 Rash, Dose 1	0	0
Related Rash, Dose 1	2	2
Any Temperature, Dose 1	11	8
Grade 3 Temperature, Dose 1	0	0
Related Temperature, Dose 1	7	5
Any Urticaria, Dose 1	3	3
Grade 3 Urticaria, Dose 1	0	0
Related Urticaria, Dose 1	3	3
Any Arthralgia, Dose 2	14	12
Grade 3 Arthralgia, Dose 2	0	0
Related Arthralgia, Dose 2	9	5
Any Fatigue, Dose 2	34	34
Grade 3 Fatigue, Dose 2	2	0
Related Fatigue, Dose 2	19	19
Any Gastrointestinal, Dose 2	9	15
Grade 3 Gastrointestinal, Dose 2	1	1
Related Gastrointestinal, Dose 2	7	6
Any Headache, Dose 2	35	31
Grade 3 Headache, Dose 2	5	2
Related Headache, Dose 2	23	19
Any Myalgia, Dose 2	36	26
Grade 3 Myalgia, Dose 2	1	0
Related Myalgia, Dose 2	28	19
Any Rash, Dose 2	2	4
Grade 3 Rash, Dose 2	0	0
Related Rash, Dose 2	1	1
Any Temperature, Dose 2	10	10
Grade 3 Temperature, Dose 2	1	0
Related Temperature, Dose 2	5	8
Any Urticaria, Dose 2	1	1
Grade 3 Urticaria, Dose 2	0	0
Related Urticaria, Dose 2	1	1
Any Arthralgia, Dose 3	9	14
Grade 3 Arthralgia, Dose 3	0	2
Related Arthralgia, Dose 3	9	11
Any Fatigue, Dose 3	32	20
Grade 3 Fatigue, Dose 3	1	2
Related Fatigue, Dose 3	29	15
Any Gastrointestinal, Dose 3	7	9
Grade 3 Gastrointestinal, Dose 3	1	0
Related Gastrointestinal, Dose 3	6	6
Any Headache, Dose 3	33	25
Grade 3 Headache, Dose 3	3	2
Related Headache, Dose 3	26	17
Any Myalgia, Dose 3	26	28
Grade 3 Myalgia, Dose 3	2	2
Related Myalgia, Dose 3	22	21
Any Rash, Dose 3	2	0
Grade 3 Rash, Dose 3	0	0
Related Rash, Dose 3	2	0
Any Temperature, Dose 3	9	10
Grade 3 Temperature, Dose 3	2	1
Related Temperature, Dose 3	7	6
Any Urticaria, Dose 3	2	3
Grade 3 Urticaria, Dose 3	0	0
Related Urticaria, Dose 3	2	3
Any Arthralgia, Across Doses	31	34
Grade 3 Arthralgia, Across Doses	0	2
Related Arthralgia, Across Doses	20	18
Any Fatigue, Across Doses	65	56
Grade 3 Fatigue, Across Doses	5	4
Related Fatigue, Across Doses	45	33
Any Gastrointestinal, Across Doses	28	26
Grade 3 Gastrointestinal, Across Doses	2	1
Related Gastrointestinal, Across Doses	17	17
Any Headache, Across Doses	69	67
Grade 3 Headache, Across Doses	7	5
Related Headache, Across Doses	51	40
Any Myalgia, Across Doses	64	53
Grade 3 Myalgia, Across Doses	3	4
Related Myalgia, Across Doses	44	40
Any Rash, Across Doses	5	8
Grade 3 Rash, Across Doses	0	0
Related Rash, Across Doses	5	3
Any Temperature, Across Doses	22	24
Grade 3 Temperature, Across Doses	3	1
Related Temperature, Across Doses	16	16
Any Urticaria, Across Doses	4	6
Grade 3 Urticaria, Across Doses	0	0
Related Urticaria, Across Doses	4	6

SecondaryNumber of HIV- Subjects With Unsolicited Adverse Events (AEs)

Time frame:: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
Reported as:: Count of participants · Participants

Number of HIV- Subjects With Unsolicited Adverse Events (AEs)
Participants	HIV-/Cervarix Group	HIV-/Gardasil Group
Any AE(s)	26	32
Grade 3 AE(s)	1	3
Related AE(s)	4	2

SecondaryNumber of HIV- Subjects With Serious Adverse Events (SAEs)

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV- Subjects With Serious Adverse Events (SAEs)
Participants	HIV-/Cervarix Group	HIV-/Gardasil Group
Number of HIV- Subjects With Serious Adverse Events (SAEs)	1	0

SecondaryNumber of HIV- Subjects With Medically Significant Conditions (MSCs)

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV- Subjects With Medically Significant Conditions (MSCs)
Participants	HIV-/Cervarix Group	HIV-/Gardasil Group
Number of HIV- Subjects With Medically Significant Conditions (MSCs)	7	14

SecondaryNumber of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)

Time frame:: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)
Participants	HIV-/Cervarix Group	HIV-/Gardasil Group
Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)	0	0

SecondaryNumber of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Time frame:: During the entire study period (from Day 0 up to Month 24)
Reported as:: Count of participants · Participants

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
Live infant NO apparent congenital anomaly	8	7	3	7
Live infant congenital anomaly	0	0	0	0
Elective termin. NO apparent congenital anomaly	1	0	0	0
Elective termin. congenital anomaly	0	0	0	0
Ectopic pregnancy	0	0	0	0
Spontaneous abortion NO apparent congen. anomaly	1	1	0	0
Stillbirth NO apparent congenital anomaly	0	0	0	0
Stillbirth congenital anomaly	0	0	0	0
Lost to follow-up	0	0	0	0
Pregnancy ongoing	0	0	0	0
Missing	0	0	0	0

SecondaryNumber of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters

Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophils \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
Reported as:: Count of participants · Participants

Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
ALAT, Day 0, Unknown	0	0	0	0
ALAT, Week 6, Unknown	0	0	0	0
ALAT, Week 10, Unknown	1	0	0	0
ALAT, Month 6, Unknown	0	0	0	0
ALAT, Month 7, Unknown	0	0	0	0
ALAT, Month 12, Unknown	0	0	0	1
ALAT, Month 18, Unknown	0	0	0	0
ALAT, Month 24, Unknown	0	0	0	0
ALAT, Day 0, Below	9	4	33	35
ALAT, Week 6, Below	4	5	35	32
ALAT, Week 10, Below	2	8	27	26
ALAT, Month 6, Below	3	4	25	27
ALAT, Month 7, Below	4	3	20	23
ALAT, Month 12, Below	6	1	20	22
ALAT, Month 18, Below	2	2	23	17
ALAT, Month 24, Below	0	1	14	14
ALAT, Day 0, Within	109	118	109	106
ALAT, Week 6, Within	119	115	97	106
ALAT, Week 10, Within	117	110	104	109
ALAT, Month 6, Within	112	110	101	102
ALAT, Month 7, Within	110	105	94	98
ALAT, Month 12, Within	104	112	86	95
ALAT, Month 18, Within	115	109	85	98
ALAT, Month 24, Within	112	110	87	95
ALAT, Day 0, Above	11	6	2	4
ALAT, Week 6, Above	5	6	5	4
ALAT, Week 10, Above	8	9	4	1
ALAT, Month 6, Above	8	9	2	5
ALAT, Month 7, Above	7	13	1	4
ALAT, Month 12, Above	12	6	2	0
ALAT, Month 18, Above	4	6	2	2
ALAT, Month 24, Above	4	6	2	2
BSPH, Day 0, Unknown	0	0	0	0
BSPH, Week 6, Unknown	0	0	2	3
BSPH, Week 10, Unknown	0	0	0	0
BSPH, Month 6, Unknown	0	0	0	0
BSPH, Month 7, Unknown	0	0	0	0
BSPH, Month 12, Unknown	1	0	0	0
BSPH, Month 18, Unknown	0	0	0	0
BSPH, Month 24, Unknown	1	0	0	0
BSPH, Day 0, Below	0	1	21	20
BSPH, Week 6, Below	0	1	8	7
BSPH, Week 10, Below	0	0	15	17
BSPH, Month 6, Below	0	0	12	13
BSPH, Month 7, Below	0	0	6	8
BSPH, Month 12, Below	0	0	6	7
BSPH, Month 18, Below	0	0	10	12
BSPH, Month 24, Below	0	0	7	8
BSPH, Day 0, Within	129	127	123	125
BSPH, Week 6, Within	128	125	127	131
BSPH, Week 10, Within	127	124	119	119
BSPH, Month 6, Within	123	122	116	120
BSPH, Month 7, Within	120	121	109	116
BSPH, Month 12, Within	121	119	102	111
BSPH, Month 18, Within	120	117	99	104
BSPH, Month 24, Within	115	117	96	102
BSPH, Day 0, Above	0	0	0	0
BSPH, Week 6, Above	0	0	0	1
BSPH, Week 10, Above	1	3	1	0
BSPH, Month 6, Above	0	1	0	1
BSPH, Month 7, Above	1	0	0	1
BSPH, Month 12, Above	0	0	0	0
BSPH, Month 18, Above	1	0	1	1
BSPH, Month 24, Above	0	0	0	1
CRT, Day 0, Unknown	0	0	0	0
CRT, Week 6, Unknown	0	0	0	0
CRT, Week 10, Unknown	0	0	0	0
CRT, Month 6, Unknown	0	0	0	0
CRT, Month 7, Unknown	0	0	0	0
CRT, Month 12, Unknown	0	0	0	0
CRT, Month 18, Unknown	0	0	0	0
CRT, Month 24, Unknown	0	0	0	0
CRT, Day 0, Below	31	26	27	21
CRT, Week 6, Below	35	28	36	28
CRT, Week 10, Below	33	30	27	29
CRT, Month 6, Below	33	32	25	26
CRT, Month 7, Below	29	36	22	17
CRT, Month 12, Below	25	23	24	22
CRT, Month 18, Below	25	17	11	12
CRT, Month 24, Below	27	30	17	17
CRT, Day 0, Within	97	100	115	123
CRT, Week 6, Within	93	97	101	113
CRT, Week 10, Within	95	96	108	107
CRT, Month 6, Within	89	89	103	107
CRT, Month 7, Within	91	84	93	107
CRT, Month 12, Within	94	91	83	95
CRT, Month 18, Within	93	98	98	102
CRT, Month 24, Within	88	85	86	93
CRT, Day 0, Above	1	1	2	1
CRT, Week 6, Above	0	0	0	1
CRT, Week 10, Above	0	0	0	0
CRT, Month 6, Above	1	1	0	1
CRT, Month 7, Above	1	0	0	1
CRT, Month 12, Above	3	4	1	1
CRT, Month 18, Above	3	1	1	3
CRT, Month 24, Above	1	1	0	1
ESPH, Day 0, Unknown	0	0	0	0
ESPH, Week 6, Unknown	0	0	2	3
ESPH, Week 10, Unknown	0	0	0	0
ESPH, Month 6, Unknown	0	0	0	0
ESPH, Month 7, Unknown	0	0	0	0
ESPH, Month 12, Unknown	1	0	0	0
ESPH, Month 18, Unknown	0	0	0	0
ESPH, Month 24, Unknown	1	0	0	0
ESPH, Day 0, Below	15	18	3	4
ESPH, Week 6, Below	10	13	7	6
ESPH, Week 10, Below	11	12	3	1
ESPH, Month 6, Below	9	13	4	4
ESPH, Month 7, Below	9	10	6	6
ESPH, Month 12, Below	9	10	3	6
ESPH, Month 18, Below	4	9	6	4
ESPH, Month 24, Below	7	15	3	6
ESPH, Day 0, Within	108	102	130	133
ESPH, Week 6, Within	109	102	115	126
ESPH, Week 10, Within	112	108	125	130
ESPH, Month 6, Within	103	108	118	124
ESPH, Month 7, Within	108	106	103	112
ESPH, Month 12, Within	105	104	98	107
ESPH, Month 18, Within	111	106	96	105
ESPH, Month 24, Within	103	99	99	99
ESPH, Day 0, Above	6	8	11	8
ESPH, Week 6, Above	9	11	13	7
ESPH, Week 10, Above	5	7	7	5
ESPH, Month 6, Above	11	2	6	6
ESPH, Month 7, Above	4	5	6	7
ESPH, Month 12, Above	7	5	7	5
ESPH, Month 18, Above	6	2	8	8
ESPH, Month 24, Above	5	3	1	6

SecondaryNumber of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters

Among assessed haematological parameters were: haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\] and monocytes \[MONO\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
Reported as:: Count of participants · Participants

Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
HTCR, Day 0, Unknown	0	0	0	0
HTCR, Week 6, Unknown	0	1	0	0
HTCR, Week 10, Unknown	0	0	0	0
HTCR, Month 6, Unknown	0	0	0	0
HTCR, Month 7, Unknown	0	0	0	1
HTCR, Month 12, Unknown	1	0	0	0
HTCR, Month 18, Unknown	0	0	0	0
HTCR, Month 24, Unknown	1	0	0	0
HTCR, Day 0, Below	32	23	24	24
HTCR, Week 6, Below	22	17	18	13
HTCR, Week 10, Below	30	22	11	7
HTCR, Month 6, Below	26	27	13	17
HTCR, Month 7, Below	19	27	13	14
HTCR, Month 12, Below	24	25	15	17
HTCR, Month 18, Below	30	22	17	16
HTCR, Month 24, Below	24	24	21	17
HTCR, Day 0, Within	96	102	120	118
HTCR, Week 6, Within	106	105	119	125
HTCR, Week 10, Within	97	103	123	126
HTCR, Month 6, Within	97	95	115	117
HTCR, Month 7, Within	101	92	102	108
HTCR, Month 12, Within	95	94	93	100
HTCR, Month 18, Within	91	92	90	101
HTCR, Month 24, Within	91	92	82	93
HTCR, Day 0, Above	1	3	0	3
HTCR, Week 6, Above	0	3	0	4
HTCR, Week 10, Above	1	2	1	3
HTCR, Month 6, Above	0	1	0	0
HTCR, Month 7, Above	1	2	0	2
HTCR, Month 12, Above	2	0	0	1
HTCR, Month 18, Above	0	3	3	0
HTCR, Month 24, Above	0	1	0	1
HGB, Day 0, Unknown	0	0	0	0
HGB, Week 6, Unknown	0	0	0	0
HGB, Week 10, Unknown	0	0	0	0
HGB, Month 6, Unknown	0	0	0	0
HGB, Month 7, Unknown	0	0	0	0
HGB, Month 12, Unknown	1	0	0	0
HGB, Month 18, Unknown	0	0	0	0
HGB, Month 24, Unknown	1	0	0	0
HGB, Day 0, Below	38	37	40	45
HGB, Week 6, Below	38	35	40	50
HGB, Week 10, Below	38	35	37	38
HGB, Month 6, Below	38	36	45	38
HGB, Month 7, Below	28	37	36	38
HGB, Month 12, Below	29	35	39	39
HGB, Month 18, Below	34	32	32	35
HGB, Month 24, Below	27	27	28	26
HGB, Day 0, Within	88	89	104	98
HGB, Week 6, Within	88	88	97	88
HGB, Week 10, Within	89	90	98	97
HGB, Month 6, Within	85	86	83	96
HGB, Month 7, Within	92	83	79	86
HGB, Month 12, Within	91	83	69	79
HGB, Month 18, Within	84	82	77	82
HGB, Month 24, Within	88	89	75	84
HGB, Day 0, Above	3	2	0	2
HGB, Week 6, Above	2	3	0	4
HGB, Week 10, Above	1	2	0	1
HGB, Month 6, Above	0	1	0	0
HGB, Month 7, Above	1	1	0	1
HGB, Month 12, Above	1	1	0	0
HGB, Month 18, Above	3	3	1	0
HGB, Month 24, Above	0	1	0	1
LYMP, Day 0, Unknown	0	0	0	0
LYMP, Week 6, Unknown	0	0	2	3
LYMP, Week 10, Unknown	0	0	0	0
LYMP, Month 6, Unknown	0	0	0	0
LYMP, Month 7, Unknown	0	0	0	0
LYMP, Month 12, Unknown	1	0	0	0
LYMP, Month 18, Unknown	0	0	0	0
LYMP, Month 24, Unknown	1	0	0	0
LYMP, Day 0, Below	7	9	11	6
LYMP, Week 6, Below	6	11	12	6
LYMP, Week 10, Below	11	9	13	6
LYMP, Month 6, Below	6	8	9	11
LYMP, Month 7, Below	12	11	6	6
LYMP, Month 12, Below	6	10	6	8
LYMP, Month 18, Below	4	4	6	4
LYMP, Month 24, Below	8	9	6	7
LYMP, Day 0, Within	105	105	120	132
LYMP, Week 6, Within	109	109	113	121
LYMP, Week 10, Within	101	102	110	124
LYMP, Month 6, Within	98	104	106	115
LYMP, Month 7, Within	96	97	103	111
LYMP, Month 12, Within	104	95	92	98
LYMP, Month 18, Within	105	103	94	106
LYMP, Month 24, Within	98	97	88	101
LYMP, Day 0, Above	17	14	13	7
LYMP, Week 6, Above	13	6	10	12
LYMP, Week 10, Above	16	16	12	6
LYMP, Month 6, Above	19	11	13	8
LYMP, Month 7, Above	13	13	6	8
LYMP, Month 12, Above	11	14	10	12
LYMP, Month 18, Above	12	10	10	7
LYMP, Month 24, Above	9	11	9	3
MONO, Day 0, Unknown	0	0	0	0
MONO, Week 6, Unknown	0	0	2	3
MONO, Week 10, Unknown	0	0	0	0
MONO, Month 6, Unknown	0	0	0	0
MONO, Month 7, Unknown	0	0	0	0
MONO, Month 12, Unknown	1	0	0	0
MONO, Month 18, Unknown	0	0	0	0
MONO, Month 24, Unknown	1	0	0	0
MONO, Day 0, Below	7	4	10	17
MONO, Week 6, Below	4	4	3	4
MONO, Week 10, Below	4	4	2	6
MONO, Month 6, Below	3	5	0	7
MONO, Month 7, Below	4	7	5	2
MONO, Month 12, Below	2	5	5	2
MONO, Month 18, Below	3	6	5	4
MONO, Month 24, Below	5	5	7	10
MONO, Day 0, Within	111	117	133	126
MONO, Week 6, Within	117	112	129	133
MONO, Week 10, Within	116	108	129	127
MONO, Month 6, Within	107	104	113	121
MONO, Month 7, Within	106	97	107	118
MONO, Month 12, Within	104	101	101	113
MONO, Month 18, Within	108	99	101	109
MONO, Month 24, Within	98	99	95	99
MONO, Day 0, Above	11	7	1	2
MONO, Week 6, Above	7	10	3	2
MONO, Week 10, Above	8	15	4	3
MONO, Month 6, Above	13	14	6	6
MONO, Month 7, Above	11	17	3	5
MONO, Month 12, Above	15	13	2	3
MONO, Month 18, Above	10	12	4	4
MONO, Month 24, Above	12	13	1	2

SecondaryNumber of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters

Among assessed haematological parameters were: neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
Reported as:: Count of participants · Participants

Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
NTPH, Day 0, Unknown	0	0	0	0
NTPH, Week 6, Unknown	0	0	2	3
NTPH, Week 10, Unknown	0	0	0	0
NTPH, Month 6, Unknown	0	0	0	0
NTPH, Month 7, Unknown	0	0	0	0
NTPH, Month 12, Unknown	1	0	0	0
NTPH, Month 18, Unknown	0	0	0	0
NTPH, Month 24, Unknown	1	0	0	0
NTPH, Day 0, Below	14	12	11	7
NTPH, Week 6, Below	16	13	8	13
NTPH, Week 10, Below	18	17	12	10
NTPH, Month 6, Below	18	14	15	14
NTPH, Month 7, Below	16	17	10	9
NTPH, Month 12, Below	19	16	12	11
NTPH, Month 18, Below	15	15	9	14
NTPH, Month 24, Below	14	11	9	10
NTPH, Day 0, Within	106	99	117	122
NTPH, Week 6, Within	101	95	107	116
NTPH, Week 10, Within	103	100	104	113
NTPH, Month 6, Within	100	98	98	104
NTPH, Month 7, Within	97	93	92	106
NTPH, Month 12, Within	92	93	84	94
NTPH, Month 18, Within	98	89	86	92
NTPH, Month 24, Within	92	95	83	89
NTPH, Day 0, Above	9	17	16	16
NTPH, Week 6, Above	11	18	20	10
NTPH, Week 10, Above	7	10	19	13
NTPH, Month 6, Above	5	11	15	16
NTPH, Month 7, Above	8	11	13	10
NTPH, Month 12, Above	10	10	12	13
NTPH, Month 18, Above	8	13	15	11
NTPH, Month 24, Above	9	11	11	12
PLAT, Day 0, Unknown	0	0	0	0
PLAT, Week 6, Unknown	0	0	1	1
PLAT, Week 10, Unknown	0	0	1	0
PLAT, Month 6, Unknown	0	0	0	0
PLAT, Month 7, Unknown	0	0	1	0
PLAT, Month 12, Unknown	1	0	1	0
PLAT, Month 18, Unknown	0	0	0	0
PLAT, Month 24, Unknown	1	0	0	0
PLAT, Day 0, Below	0	0	3	0
PLAT, Week 6, Below	1	0	1	0
PLAT, Week 10, Below	1	1	0	0
PLAT, Month 6, Below	2	2	0	0
PLAT, Month 7, Below	1	3	1	1
PLAT, Month 12, Below	3	1	0	2
PLAT, Month 18, Below	3	4	1	2
PLAT, Month 24, Below	1	2	2	3
PLAT, Day 0, Within	123	122	133	138
PLAT, Week 6, Within	124	119	130	137
PLAT, Week 10, Within	122	124	131	132
PLAT, Month 6, Within	116	118	127	131
PLAT, Month 7, Within	118	114	110	121
PLAT, Month 12, Within	113	114	103	111
PLAT, Month 18, Within	117	110	106	111
PLAT, Month 24, Within	109	110	97	103
PLAT, Day 0, Above	6	6	8	7
PLAT, Week 6, Above	3	7	5	4
PLAT, Week 10, Above	5	2	3	4
PLAT, Month 6, Above	5	3	1	3
PLAT, Month 7, Above	2	4	3	3
PLAT, Month 12, Above	5	4	4	5
PLAT, Month 18, Above	1	3	3	4
PLAT, Month 24, Above	5	5	4	5
RBC, Day 0, Unknown	0	0	0	0
RBC, Week 6, Unknown	0	0	0	1
RBC, Week 10, Unknown	0	0	0	0
RBC, Month 6, Unknown	0	0	0	1
RBC, Month 7, Unknown	0	0	0	0
RBC, Month 12, Unknown	1	0	0	1
RBC, Month 18, Unknown	0	0	2	3
RBC, Month 24, Unknown	1	0	0	0
RBC, Day 0, Below	43	38	18	13
RBC, Week 6, Below	44	36	14	12
RBC, Week 10, Below	48	37	11	8
RBC, Month 6, Below	40	39	14	12
RBC, Month 7, Below	36	34	15	19
RBC, Month 12, Below	39	31	19	14
RBC, Month 18, Below	38	31	9	13
RBC, Month 24, Below	38	34	10	9
RBC, Day 0, Within	83	87	118	123
RBC, Week 6, Within	81	85	118	120
RBC, Week 10, Within	78	87	120	122
RBC, Month 6, Within	79	81	111	117
RBC, Month 7, Within	82	84	100	100
RBC, Month 12, Within	79	86	88	100
RBC, Month 18, Within	81	80	97	96
RBC, Month 24, Within	74	83	91	98
RBC, Day 0, Above	3	3	5	5
RBC, Week 6, Above	3	5	4	6
RBC, Week 10, Above	2	3	3	5
RBC, Month 6, Above	4	3	2	4
RBC, Month 7, Above	3	3	0	6
RBC, Month 12, Above	3	2	1	3
RBC, Month 18, Above	2	6	2	4
RBC, Month 24, Above	3	0	2	4
WBC, Day 0, Unknown	0	0	0	0
WBC, Week 6, Unknown	0	0	0	0
WBC, Week 10, Unknown	0	0	0	0
WBC, Month 6, Unknown	0	0	0	0
WBC, Month 7, Unknown	0	0	0	0
WBC, Month 12, Unknown	1	0	0	0
WBC, Month 18, Unknown	0	0	0	0
WBC, Month 24, Unknown	1	0	0	0
WBC, Day 0, Below	8	7	5	2
WBC, Week 6, Below	9	11	5	4
WBC, Week 10, Below	9	9	2	3
WBC, Month 6, Below	12	6	2	2
WBC, Month 7, Below	10	9	5	1
WBC, Month 12, Below	14	13	3	2
WBC, Month 18, Below	12	10	4	5
WBC, Month 24, Below	11	5	3	4
WBC, Day 0, Within	118	116	135	140
WBC, Week 6, Within	118	111	124	135
WBC, Week 10, Within	116	113	131	129
WBC, Month 6, Within	106	116	122	128
WBC, Month 7, Within	106	108	106	120
WBC, Month 12, Within	103	103	100	115
WBC, Month 18, Within	106	107	100	107
WBC, Month 24, Within	102	107	94	101
WBC, Day 0, Above	3	5	3	3
WBC, Week 6, Above	1	4	7	3
WBC, Week 10, Above	3	5	1	4
WBC, Month 6, Above	5	1	3	4
WBC, Month 7, Above	5	4	3	4
WBC, Month 12, Above	4	3	4	1
WBC, Month 18, Above	3	0	5	5
WBC, Month 24, Above	2	5	5	6

SecondaryNumber of Subjects With SAEs

Time frame:: During the entire study period (from Day 0 up to Month 24)
Reported as:: Count of participants · Participants

Number of Subjects With SAEs
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
Number of Subjects With SAEs	9	9	4	1

SecondaryNumber of Subjects With Medically Significant Conditions (MSCs)

Time frame:: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of Subjects With Medically Significant Conditions (MSCs)
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
Number of Subjects With Medically Significant Conditions (MSCs)	25	37	10	17

SecondaryNumber of Subjects With Potential Immune-mediated Diseases (pIMDs)

Time frame:: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
Reported as:: Count of participants · Participants

Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)	1	0	0	0

SecondaryCluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24

CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.

Time frame:: At Months 12, 18 and 24
Reported as:: Median · cells/mm3

Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24
cells/mm3	HIV+/Cervarix Group	HIV+/Gardasil Group
CD4+ cell counts, Month 12	584.5 (498.0 to 832.0)	602.0 (445.0 to 835.0)
CD4+ cell counts, Month 18	621.0 (472.0 to 789.0)	572.0 (443.0 to 770.0)
CD4+ cell counts, Month 24	568.0 (447.0 to 738.0)	598.0 (441.0 to 834.0)

SecondaryHIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24

HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.

Time frame:: At Months 12, 18 and 24
Reported as:: Median · HIV copies/mL

HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24
HIV copies/mL	HIV+/Cervarix Group	HIV+/Gardasil Group
HIV viral load, Month 12	1.6 (1.3 to 3.2)	2.3 (1.3 to 3.7)
HIV viral load, Month 18	1.7 (1.3 to 3.2)	2.2 (1.3 to 3.8)
HIV viral load, Month 24	1.6 (1.3 to 2.8)	2.1 (1.3 to 3.8)

SecondaryNumber of HIV+ Subjects by WHO HIV Clinical Staging

HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].

Time frame:: At Months 12, 18 and 24
Reported as:: Count of participants · Participants

Number of HIV+ Subjects by WHO HIV Clinical Staging
Participants	HIV+/Cervarix Group	HIV+/Gardasil Group
Clinical stage 1, Month 12	113	112
Clinical stage 2, Month 12	7	1
Clinical stage 3, Month 12	1	2
Clinical stage 4, Month 12	2	4
Clinical stage 1, Month 18	112	110
Clinical stage 2, Month 18	7	1
Clinical stage 3, Month 18	1	2
Clinical stage 4, Month 18	2	4
Clinical stage 1, Month 24	107	110
Clinical stage 2, Month 24	7	1
Clinical stage 3, Month 24	1	2
Clinical stage 4, Month 24	2	4

SecondaryPseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], for HIV- subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).

Time frame:: At Month 7 (30 days after the last vaccination dose at Month 6)
Reported as:: Geometric mean · Titers

Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC
Titers	HIV-/Cervarix Group	HIV-/Gardasil Group
Anti-HPV-16	60550.6 (44040.1 to 83250.9)	19634.8 (14410.8 to 26752.4)
Anti-HPV-18	32118.1 (23195.8 to 44472.3)	5773.4 (4205.2 to 7926.4)

Statistical analysis

HIV-/Cervarix Group vs HIV-/Gardasil Group · ANOVA · p = <0.0001 · Adjusted gmt ratio: 5.38 · 97.5% CI 3.20 to 9.06ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.
HIV-/Cervarix Group vs HIV-/Gardasil Group · ANOVA · p = <0.0001 · Adjusted gmt ratio: 3.05 · 97.5% CI 1.84 to 5.06ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.

SecondaryAnti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum

Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.

Time frame:: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
Reported as:: Geometric mean · EU/mL

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
EU/mL	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
anti-HPV-16, Day 0	17.2 (13.3 to 22.2)	15.0 (12.0 to 18.9)	10.2 (9.4 to 11.0)	10.9 (9.5 to 12.5)
anti-HPV-16, Week 6	452.9 (302.3 to 678.5)	280.2 (182.5 to 430.1)	390.6 (298.3 to 511.6)	303.2 (228.0 to 403.3)
anti-HPV-16, Week 10	2191.2 (1775.7 to 2704.0)	1565.5 (1197.5 to 2046.6)	4512.7 (3771.5 to 5399.7)	2993.2 (2459.1 to 3643.3)
anti-HPV-16, Month 7	4896.0 (4002.2 to 5989.3)	2145.2 (1647.8 to 2792.7)	15493.0 (12537.0 to 19146.0)	5960.9 (5028.9 to 7065.7)
anti-HPV-16, Month 12	1392.3 (1077.5 to 1799.0)	608.8 (445.4 to 832.1)	4389.3 (3400.5 to 5665.7)	1772.2 (1473.3 to 2131.7)
anti-HPV-16, Month 18	861.3 (662.3 to 1119.9)	311.4 (226.3 to 428.4)	2294.1 (1785.0 to 2948.4)	798.0 (646.6 to 984.8)
anti-HPV-16, Month 24	664.6 (499.9 to 883.7)	243.5 (173.9 to 341.0)	1893.6 (1443.8 to 2483.7)	601.9 (481.8 to 752.1)
anti-HPV-18, Day 0	13.4 (11.2 to 16.0)	10.7 (9.3 to 12.3)	9.3 (8.9 to 9.8)	9.2 (8.9 to 9.5)
anti-HPV-18, Week 6	205.6 (146.3 to 288.7)	53.2 (36.4 to 77.6)	277.3 (217.5 to 353.5)	60.4 (47.5 to 76.8)
anti-HPV-18, Week 10	1432.4 (1136.9 to 1804.6)	277.2 (200.8 to 382.8)	3174.4 (2596.2 to 3881.4)	666.1 (549.8 to 806.9)
anti-HPV-18, Month 7	2540.8 (2085.9 to 3094.9)	493.8 (356.6 to 683.8)	6779.3 (5382.6 to 8538.5)	1516.5 (1232.9 to 1865.2)
anti-HPV-18, Month 12	676.9 (520.1 to 880.9)	116.2 (82.2 to 164.2)	1747.7 (1329.4 to 2297.6)	338.3 (261.2 to 438.1)
anti-HPV-18, Month 18	408.7 (310.4 to 538.2)	55.6 (39.6 to 78.0)	895.5 (679.6 to 1179.9)	160.1 (123.7 to 207.1)
anti-HPV-18, Month 24	295.2 (216.9 to 401.7)	52.4 (37.2 to 73.8)	761.9 (576.6 to 1006.7)	116.2 (88.8 to 151.9)

SecondaryAnti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)

Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.

Time frame:: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
Reported as:: Geometric mean · EU/mL

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
EU/mL	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
anti-HPV-16, Day 0	1.5 (0.8 to 2.6)	1.4 (0.7 to 2.8)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
anti-HPV-16, Week 6	31.5 (4.7 to 211.5)	3.1 (0.8 to 11.6)	27.1 (8.7 to 84.2)	2.7 (0.4 to 16.5)
anti-HPV-16, Week 10	38.8 (6.1 to 245.0)	15.7 (5.4 to 45.2)	—	159.8 (NA to NA)
anti-HPV-16, Month 7	23.6 (3.4 to 163.0)	5.4 (1.6 to 17.6)	104.2 (40.3 to 269.4)	53.5 (3.0 to 945.1)
anti-HPV-16, Month 12	18.7 (3.2 to 109.0)	6.8 (2.1 to 22.3)	107.6 (29.1 to 398.1)	34.7 (NA to NA)
anti-HPV-16, Month 24	8.1 (1.3 to 50.3)	4.3 (1.4 to 12.9)	49.0 (4.5 to 534.2)	1.0 (NA to NA)
anti-HPV-18, Day 0	1.2 (0.8 to 1.9)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
anti-HPV-18, Week 6	16.8 (2.5 to 113.1)	1.7 (0.5 to 5.2)	3.0 (0.0 to 312.7)	1.0 (1.0 to 1.0)
anti-HPV-18, Week 10	22.9 (3.4 to 152.2)	2.3 (0.9 to 5.8)	—	21.6 (NA to NA)
anti-HPV-18, Month 7	10.1 (1.8 to 58.2)	2.2 (1.0 to 4.8)	44.2 (14.3 to 136.9)	16.3 (1.0 to 265.0)
anti-HPV-18, Month 12	23.9 (8.0 to 72.0)	2.4 (0.9 to 6.8)	32.7 (17.2 to 62.1)	16.3 (NA to NA)
anti-HPV-18, Month 24	8.8 (1.6 to 48.5)	1.5 (0.8 to 3.0)	13.8 (1.3 to 149.2)	1.0 (NA to NA)

SecondaryFrequency of Specific B-cells for HPV-16/18 Antigens

B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).

Time frame:: At Day 0, Week 6, Week 10, Month 7 and Month 12
Reported as:: Median · B-cells/million cells

Frequency of Specific B-cells for HPV-16/18 Antigens
B-cells/million cells	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
HPV-16, Day 0	1.0 (1.0 to 1.0)	1.0 (1.0 to 61.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
HPV-18, Day 0	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
HPV-16, Week 6	91.0 (1.0 to 154.0)	1.0 (1.0 to 1.0)	22.0 (1.0 to 154.0)	1.0 (1.0 to 204.0)
HPV-18, Week 6	39.5 (1.0 to 693.0)	1.0 (1.0 to 45.5)	155.0 (1.0 to 345.0)	33.0 (1.0 to 80.0)
HPV-16, Week 10	558.0 (95.5 to 989.5)	198.0 (1.0 to 391.0)	494.0 (90.5 to 834.0)	150.5 (33.5 to 726.5)
HPV-18, Week 10	150.0 (31.0 to 471.0)	1.0 (1.0 to 42.0)	211.0 (84.0 to 656.0)	29.5 (1.0 to 222.0)
HPV-16, Month 7	624.0 (457.0 to 1196.0)	213.0 (165.0 to 632.0)	1504.0 (481.0 to 3026.0)	448.0 (257.0 to 890.0)
HPV-18, Month 7	332.0 (153.0 to 494.0)	1.0 (1.0 to 392.0)	513.5 (111.5 to 1292.0)	65.0 (1.0 to 158.0)
HPV-16, Month 12	256.5 (75.5 to 891.5)	121.0 (64.5 to 315.0)	414.5 (94.5 to 640.5)	256.0 (218.0 to 449.0)
HPV-18, Month 12	101.0 (1.0 to 525.0)	1.0 (1.0 to 159.0)	250.5 (1.0 to 481.5)	58.0 (1.0 to 101.0)

SecondaryFrequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response

The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).

Time frame:: At Day 0, Week 6, Week 10, Month 7 and Month 12
Reported as:: Median · CD4 cells/million T-cells

Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4 cells/million T-cells	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
CD4-All doubles,Anti-HPV-16,Day 0	41.0 (1.0 to 118.0)	101.0 (43.0 to 215.0)	1.0 (1.0 to 28.0)	54.5 (1.0 to 88.0)
CD4-All doubles,Anti-HPV-18,Day 0	7.0 (1.0 to 116.0)	87.0 (18.0 to 184.0)	1.0 (1.0 to 82.0)	1.0 (1.0 to 98.0)
CD4-All doubles,Anti-HPV-16,Week 6	445.5 (262.0 to 1028.0)	345.5 (227.0 to 1034.0)	298.0 (173.0 to 540.5)	661.0 (234.0 to 982.0)
CD4-All doubles,Anti-HPV-18,Week 6	396.0 (163.0 to 832.0)	309.5 (203.0 to 852.0)	237.0 (81.0 to 421.5)	320.5 (117.0 to 524.0)
CD4-All doubles,Anti-HPV-16,Week 10	2955.5 (1075.0 to 5200.0)	1449.0 (922.0 to 1778.0)	1767.0 (916.0 to 4428.0)	1268.5 (648.0 to 2453.0)
CD4-All doubles,Anti-HPV-18,Week 10	2036.5 (951.0 to 3123.0)	602.0 (498.0 to 2079.0)	1243.0 (587.0 to 3400.0)	515.5 (414.0 to 1178.0)
CD4-All doubles,Anti-HPV-16,Month 7	3693.0 (1870.0 to 5153.0)	1679.5 (1052.0 to 2734.0)	3414.5 (1424.5 to 4520.0)	1505.0 (995.0 to 2205.0)
CD4-All doubles,Anti-HPV-18,Month 7	1866.0 (1267.0 to 2875.0)	840.5 (518.0 to 1641.0)	2084.5 (911.0 to 4110.0)	669.0 (470.0 to 1035.0)
CD4-All doubles, Anti-HPV-16, Month 12	2328.0 (1225.0 to 4614.0)	1288.0 (976.0 to 2485.0)	2543.0 (1232.0 to 4264.0)	830.0 (367.0 to 1386.0)
CD4-All doubles, Anti-HPV-18, Month 12	1654.0 (836.0 to 2634.0)	808.5 (295.0 to 1932.0)	1641.0 (985.0 to 2939.0)	428.0 (162.0 to 938.0)
CD4-d-CD40L, Anti-HPV-16, Day 0	22.0 (1.0 to 118.0)	99.0 (60.0 to 215.0)	1.0 (1.0 to 58.0)	46.0 (1.0 to 81.0)
CD4-d-CD40L, Anti-HPV-18, Day 0	36.0 (1.0 to 81.0)	89.0 (1.0 to 176.0)	1.0 (1.0 to 54.0)	13.5 (1.0 to 100.0)
CD4-d-CD40L, Anti-HPV-16, Week 6	426.0 (258.5 to 999.5)	326.5 (196.0 to 1034.0)	298.0 (209.5 to 540.0)	582.0 (223.0 to 967.0)
CD4-d-CD40L, Anti-HPV-18, Week 6	403.5 (144.0 to 835.0)	296.0 (216.0 to 840.0)	242.5 (36.5 to 393.0)	310.0 (95.0 to 521.0)
CD4-d-CD40L, Anti-HPV-16, Week 10	2893.5 (988.0 to 5006.0)	1440.0 (882.0 to 1814.0)	1678.0 (917.0 to 4306.0)	1239.0 (562.0 to 2362.0)
CD4-d-CD40L, Anti-HPV-18, Week 10	2015.0 (944.0 to 3021.0)	564.5 (507.0 to 2045.0)	1051.0 (631.0 to 3317.0)	474.5 (385.0 to 811.0)
CD4-d-CD40L, Anti-HPV-16, Month 7	3658.0 (1804.0 to 5070.0)	1619.5 (1071.0 to 2600.0)	3290.0 (1464.5 to 4387.5)	1389.0 (949.0 to 2133.0)
CD4-d-CD40L, Anti-HPV-18, Month 7	1839.0 (1066.0 to 2893.0)	833.5 (518.0 to 1605.0)	2014.0 (979.0 to 3878.5)	647.0 (442.0 to 981.0)
CD4-d-CD40L, Anti-HPV-16, Month 12	2266.0 (1178.0 to 4558.0)	1278.0 (955.0 to 2478.0)	2519.0 (1232.0 to 4190.0)	862.0 (353.0 to 1197.0)
CD4-d-CD40L, Anti-HPV-18, Month 12	1668.0 (807.0 to 2427.0)	808.5 (295.0 to 1914.0)	1641.0 (984.0 to 2767.0)	394.0 (155.0 to 913.0)
CD4-d-IFNG, Anti-HPV-16, Day 0	27.0 (1.0 to 63.0)	30.0 (1.0 to 51.0)	1.0 (1.0 to 45.0)	39.0 (1.0 to 61.0)
CD4-d-IFNG, Anti-HPV-18, Day 0	4.0 (1.0 to 42.0)	51.0 (1.0 to 59.0)	1.0 (1.0 to 54.0)	21.0 (1.0 to 46.0)
CD4-d-IFNG, Anti-HPV-16, Week 6	222.5 (117.0 to 393.0)	116.0 (75.0 to 222.0)	42.5 (1.0 to 127.5)	241.5 (71.0 to 404.0)
CD4-d-IFNG, Anti-HPV-18, Week 6	98.0 (25.0 to 361.0)	104.5 (35.0 to 211.0)	1.0 (1.0 to 44.0)	129.5 (1.0 to 182.0)
CD4-d-IFNG, Anti-HPV-16, Week 10	1220.0 (554.0 to 1478.0)	450.0 (245.0 to 527.0)	332.0 (282.0 to 1251.0)	442.0 (160.0 to 935.0)
CD4-d-IFNG, Anti-HPV-18, Week 10	694.0 (342.0 to 1207.0)	326.5 (121.0 to 455.0)	222.0 (124.0 to 569.0)	202.0 (122.0 to 279.0)
CD4-d-IFNG, Anti-HPV-16, Month 7	1513.0 (891.0 to 1993.0)	585.5 (190.0 to 846.0)	731.0 (267.5 to 1245.0)	495.0 (319.0 to 859.0)
CD4-d-IFNG, Anti-HPV-18, Month 7	694.0 (409.0 to 868.0)	306.0 (171.0 to 382.0)	414.5 (245.5 to 616.5)	198.0 (126.0 to 435.0)
CD4-d-IFNG, Anti-HPV-16, Month 12	452.0 (368.0 to 1097.0)	432.0 (202.0 to 835.0)	621.0 (239.0 to 1042.0)	302.0 (129.0 to 555.0)
CD4-d-IFNG, Anti-HPV-18, Month 12	402.0 (191.0 to 585.0)	253.5 (92.0 to 415.0)	273.0 (88.0 to 406.0)	98.0 (1.0 to 154.0)
CD4-d-IL-2, Anti-HPV-16, Day 0	43.0 (1.0 to 81.0)	30.0 (7.0 to 121.0)	1.0 (1.0 to 58.0)	1.0 (1.0 to 21.0)
CD4-d-IL-2, Anti-HPV-18, Day 0	46.0 (1.0 to 115.0)	37.0 (1.0 to 102.0)	1.0 (1.0 to 31.0)	13.5 (1.0 to 57.0)
CD4-d-IL-2, Anti-HPV-16, Week 6	361.0 (235.5 to 966.0)	300.0 (234.0 to 827.0)	245.5 (137.0 to 468.0)	454.5 (228.0 to 816.0)
CD4-d-IL-2, Anti-HPV-18, Week 6	364.5 (161.0 to 858.0)	193.5 (94.0 to 687.0)	227.5 (131.5 to 379.5)	286.0 (129.0 to 413.0)
CD4-d-IL-2, Anti-HPV-16, Week 10	2503.0 (938.0 to 4606.0)	1221.0 (678.0 to 1584.0)	1542.0 (776.0 to 3499.0)	929.5 (435.0 to 2128.0)
CD4-d-IL-2, Anti-HPV-18, Week 10	1668.5 (635.0 to 2183.0)	555.5 (349.0 to 1687.0)	1183.0 (456.0 to 2311.0)	411.0 (245.0 to 891.0)
CD4-d-IL-2, Anti-HPV-16, Month 7	2847.0 (1557.0 to 4064.0)	1318.5 (672.0 to 2141.0)	2608.5 (1147.5 to 3875.0)	1128.0 (697.0 to 1574.0)
CD4-d-IL-2, Anti-HPV-18, Month 7	1522.0 (914.0 to 2285.0)	615.0 (472.0 to 1234.0)	1442.0 (811.0 to 3471.0)	537.0 (341.0 to 643.0)
CD4-d-IL-2, Anti-HPV-16, Month 12	1792.0 (1076.0 to 4087.0)	1040.5 (804.0 to 1972.0)	1861.0 (1861.0 to 3754.0)	723.0 (330.0 to 1255.0)
CD4-d-IL-2, Anti-HPV-18, Month 12	1170.0 (683.0 to 2375.0)	601.5 (230.0 to 1568.0)	1342.0 (825.0 to 2794.0)	337.0 (243.0 to 636.0)
CD4-d-TNFA, Anti-HPV-16, Day 0	1.0 (1.0 to 58.0)	71.0 (1.0 to 252.0)	32.0 (1.0 to 74.0)	34.0 (1.0 to 76.0)
CD4-d-TNFA, Anti-HPV-18, Day 0	1.0 (1.0 to 52.0)	35.0 (1.0 to 131.0)	25.0 (1.0 to 39.0)	15.5 (1.0 to 83.0)
CD4-d-TNFA, Anti-HPV-16, Week 6	326.5 (49.5 to 714.0)	171.0 (133.0 to 701.0)	237.0 (89.5 to 325.0)	337.5 (183.0 to 648.0)
CD4-d-TNFA, Anti-HPV-18, Week 6	234.0 (66.0 to 579.0)	204.0 (94.0 to 539.0)	162.5 (75.5 to 247.0)	156.5 (72.0 to 398.0)
CD4-d-TNFA, Anti-HPV-16, Week 10	2086.0 (519.0 to 4016.0)	903.5 (606.0 to 1355.0)	1260.0 (764.0 to 3094.0)	865.5 (453.0 to 2100.0)
CD4-d-TNFA, Anti-HPV-18, Week 10	1493.5 (592.0 to 2341.0)	443.0 (248.0 to 1432.0)	899.0 (415.0 to 2310.0)	334.5 (203.0 to 958.0)
CD4-d-TNFA, Anti-HPV-16, Month 7	2688.0 (1399.0 to 3994.0)	1109.0 (670.0 to 2066.0)	2621.0 (1062.0 to 3652.5)	1215.0 (792.0 to 1665.0)
CD4-d-TNFA, Anti-HPV-18, Month 7	1366.0 (1126.0 to 2449.0)	598.0 (362.0 to 1522.0)	1614.0 (760.5 to 3463.5)	505.0 (330.0 to 683.0)
CD4-d-TNFA, Anti-HPV-16, Month 12	1937.0 (883.0 to 3961.0)	1011.5 (681.0 to 2066.0)	2344.0 (1053.0 to 3741.0)	646.0 (344.0 to 1219.0)
CD4-d-TNFA, Anti-HPV-18, Month 12	1264.0 (707.0 to 2500.0)	527.0 (174.0 to 1684.0)	1480.0 (703.0 to 2619.0)	358.0 (186.0 to 617.0)
CD8-All doubles,Anti-HPV-16, Day 0	1.0 (1.0 to 40.0)	1.0 (1.0 to 43.0)	1.0 (1.0 to 28.0)	1.0 (1.0 to 29.0)
CD8-All doubles,Anti-HPV-18, Day 0	6.0 (1.0 to 50.0)	23.0 (1.0 to 60.0)	21.0 (1.0 to 54.0)	1.0 (1.0 to 35.0)
CD8-All doubles,Anti-HPV-16,Week 6	2.0 (1.0 to 34.5)	13.0 (1.0 to 70.0)	1.0 (1.0 to 14.5)	1.0 (1.0 to 3.0)
CD8-All doubles,Anti-HPV-18,Week 6	37.5 (9.0 to 66.5)	2.0 (1.0 to 42.0)	1.0 (1.0 to 42.5)	30.5 (1.0 to 74.0)
CD8-All doubles,Anti-HPV-16,Week 10	41.0 (1.0 to 75.0)	3.5 (1.0 to 36.0)	1.0 (1.0 to 54.0)	1.0 (1.0 to 29.0)
CD8-All doubles,Anti-HPV-18,Week 10	11.0 (1.0 to 60.0)	1.0 (1.0 to 60.0)	5.0 (1.0 to 84.0)	1.0 (1.0 to 41.0)
CD8-All doubles,Anti-HPV-16,Month 7	51.0 (18.0 to 69.0)	9.5 (1.0 to 33.0)	1.0 (1.0 to 74.5)	2.0 (1.0 to 54.0)
CD8-All doubles,Anti-HPV-18,Month 7	41.0 (1.0 to 159.0)	30.0 (3.0 to 49.0)	15.5 (1.0 to 106.5)	24.0 (1.0 to 54.0)
CD8-All doubles,Anti-HPV-16, Month 12	1.0 (1.0 to 23.0)	34.0 (1.0 to 79.0)	23.0 (1.0 to 49.0)	1.0 (1.0 to 24.0)
CD8-All doubles,Anti-HPV-18, Month 12	25.0 (1.0 to 92.0)	1.0 (1.0 to 29.0)	1.0 (1.0 to 37.0)	1.0 (1.0 to 24.0)
CD8-d-CD40L, Anti-HPV-16, Day 0	1.0 (1.0 to 29.0)	1.0 (1.0 to 6.0)	1.0 (1.0 to 10.0)	1.0 (1.0 to 7.0)
CD8-d-CD40L, Anti-HPV-18, Day 0	1.0 (1.0 to 29.0)	1.0 (1.0 to 19.0)	1.0 (1.0 to 33.0)	1.0 (1.0 to 16.0)
CD8-d-CD40L, Anti-HPV-16, Week 6	1.0 (1.0 to 24.5)	1.0 (1.0 to 32.0)	1.0 (1.0 to 18.0)	1.0 (1.0 to 1.0)
CD8-d-CD40L, Anti-HPV-18, Week 6	9.5 (1.0 to 27.5)	1.0 (1.0 to 17.0)	1.0 (1.0 to 23.0)	1.0 (1.0 to 36.0)
CD8-d-CD40L, Anti-HPV-16, Week 10	18.5 (1.0 to 73.0)	1.0 (1.0 to 29.0)	1.0 (1.0 to 41.0)	1.0 (1.0 to 27.0)
CD8-d-CD40L, Anti-HPV-18, Week 10	10.5 (1.0 to 34.0)	2.5 (1.0 to 34.0)	26.0 (1.0 to 72.0)	1.0 (1.0 to 30.0)
CD8-d-CD40L, Anti-HPV-16, Month 7	26.0 (1.0 to 63.0)	3.0 (1.0 to 20.0)	2.0 (1.0 to 52.0)	1.0 (1.0 to 36.0)
CD8-d-CD40L, Anti-HPV-18, Month 7	4.0 (1.0 to 42.0)	15.0 (1.0 to 31.0)	38.0 (1.0 to 92.0)	4.0 (1.0 to 33.0)
CD8-d-CD40L, Anti-HPV-16, Month 12	1.0 (1.0 to 73.0)	31.0 (7.0 to 39.0)	3.0 (1.0 to 30.0)	1.0 (1.0 to 24.0)
CD8-d-CD40L, Anti-HPV-18, Month 12	23.0 (1.0 to 59.0)	1.0 (1.0 to 8.0)	1.0 (1.0 to 39.0)	1.0 (1.0 to 24.0)
CD8-d-IFNG, Anti-HPV-16, Day 0	1.0 (1.0 to 29.0)	1.0 (1.0 to 43.0)	1.0 (1.0 to 28.0)	1.0 (1.0 to 2.0)
CD8-d-IFNG, Anti-HPV-18, Day 0	6.0 (1.0 to 33.0)	19.0 (1.0 to 47.0)	21.0 (1.0 to 54.0)	4.0 (1.0 to 35.0)
CD8-d-IFNG, Anti-HPV-16, Week 6	2.5 (1.0 to 39.5)	17.5 (1.0 to 78.0)	1.0 (1.0 to 14.5)	1.0 (1.0 to 11.0)
CD8-d-IFNG, Anti-HPV-18, Week 6	27.5 (1.0 to 55.5)	1.0 (1.0 to 47.0)	1.0 (1.0 to 42.5)	35.5 (1.0 to 84.0)
CD8-d-IFNG, Anti-HPV-16, Week 10	34.0 (1.0 to 99.0)	25.0 (1.0 to 30.0)	1.0 (1.0 to 38.0)	1.0 (1.0 to 29.0)
CD8-d-IFNG, Anti-HPV-18, Week 10	3.0 (1.0 to 68.0)	7.5 (1.0 to 34.0)	24.0 (1.0 to 76.0)	1.0 (1.0 to 1.0)
CD8-d-IFNG, Anti-HPV-16, Month 7	46.0 (1.0 to 68.0)	1.0 (1.0 to 26.0)	1.0 (1.0 to 74.5)	1.0 (1.0 to 50.0)
CD8-d-IFNG, Anti-HPV-18, Month 7	41.0 (1.0 to 68.0)	21.0 (1.0 to 41.0)	4.0 (1.0 to 90.5)	3.0 (1.0 to 52.0)
CD8-d-IFNG, Anti-HPV-16, Month 12	1.0 (1.0 to 31.0)	25.0 (1.0 to 57.0)	1.0 (1.0 to 39.0)	1.0 (1.0 to 24.0)
CD8-d-IFNG, Anti-HPV-18, Month 12	23.0 (1.0 to 92.0)	1.0 (1.0 to 31.0)	1.0 (1.0 to 7.0)	1.0 (1.0 to 4.0)
CD8-d-IL-2, Anti-HPV-16, Day 0	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 16.0)
CD8-d-IL-2, Anti-HPV-18, Day 0	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-16, Week 6	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-18, Week 6	1.0 (1.0 to 23.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-16, Week 10	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 32.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-18, Week 10	1.0 (1.0 to 26.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 25.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-16, Month 7	1.0 (1.0 to 23.0)	1.0 (1.0 to 17.0)	1.0 (1.0 to 37.5)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-18, Month 7	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 29.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-16, Month 12	1.0 (1.0 to 27.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-18, Month 12	1.0 (1.0 to 48.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 19.0)	1.0 (1.0 to 1.0)
CD8-d-TNFA, Anti-HPV-16, Day 0	1.0 (1.0 to 10.0)	1.0 (1.0 to 35.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 29.0)
CD8-d-TNFA, Anti-HPV-18, Day 0	6.0 (1.0 to 50.0)	7.0 (1.0 to 54.0)	1.0 (1.0 to 33.0)	1.0 (1.0 to 34.0)
CD8-d-TNFA, Anti-HPV-16, Week 6	1.0 (1.0 to 46.0)	1.0 (1.0 to 35.0)	1.0 (1.0 to 1.0)	1.0 (1.0 to 31.0)
CD8-d-TNFA, Anti-HPV-18, Week 6	19.0 (1.0 to 50.0)	1.0 (1.0 to 57.0)	1.0 (1.0 to 28.0)	1.0 (1.0 to 26.0)
CD8-d-TNFA, Anti-HPV-16, Week 10	1.5 (1.0 to 32.0)	1.0 (1.0 to 24.0)	1.0 (1.0 to 31.0)	1.0 (1.0 to 26.0)
CD8-d-TNFA, Anti-HPV-18, Week 10	17.5 (1.0 to 34.0)	14.0 (1.0 to 61.0)	5.0 (1.0 to 42.0)	1.0 (1.0 to 34.0)
CD8-d-TNFA, Anti-HPV-16, Month 7	34.0 (1.0 to 41.0)	13.0 (1.0 to 33.0)	1.0 (1.0 to 49.0)	2.0 (1.0 to 33.0)
CD8-d-TNFA, Anti-HPV-18, Month 7	41.0 (1.0 to 111.0)	26.5 (15.0 to 58.0)	1.0 (1.0 to 58.0)	1.0 (1.0 to 32.0)
CD8-d-TNFA, Anti-HPV-16, Month 12	1.0 (1.0 to 26.0)	1.0 (1.0 to 54.0)	28.0 (1.0 to 49.0)	1.0 (1.0 to 42.0)
CD8-d-TNFA, Anti-HPV-18, Month 12	30.0 (24.0 to 62.0)	1.0 (1.0 to 28.0)	1.0 (1.0 to 48.0)	1.0 (1.0 to 40.0)

Adverse events

Collected over Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
HIV+/Cervarix Group	0/129 (0%)	9/129 (7%)	123/129 (95.3%)
HIV+/Gardasil Group	1/128 (0.8%)	9/128 (7%)	109/128 (85.2%)
HIV-/Cervarix Group	0/144 (0%)	4/144 (2.8%)	136/144 (94.4%)
HIV-/Gardasil Group	0/145 (0%)	1/145 (0.7%)	127/145 (87.6%)

Most frequent serious events

Showing 10 of 25

Most frequent serious events
Event	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
AppendicitisInfections and infestations	0/129	2/128	0/144	0/145
GastritisGastrointestinal disorders	0/129	1/128	0/144	0/145
Pneumonia bacterialInfections and infestations	0/129	1/128	0/144	0/145
Pulmonary tuberculosisInfections and infestations	0/129	1/128	0/144	0/145
TonsillitisInfections and infestations	1/129	1/128	1/144	0/145
Urinary tract infectionInfections and infestations	0/129	1/128	0/144	0/145
Suicide attemptPsychiatric disorders	0/129	1/128	0/144	0/145
Head injuryInjury, poisoning and procedural complications	0/129	1/128	0/144	0/145
ArthritisMusculoskeletal and connective tissue disorders	0/129	1/128	0/144	0/145
Abortion spontaneous completePregnancy, puerperium and perinatal conditions	0/129	1/128	0/144	0/145

Most frequent other events

Showing 10 of 121

Most frequent other events
Event	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group
PainGeneral disorders	121/129	85/128	133/144	119/145
HeadacheNervous system disorders	88/129	63/128	70/144	67/145
FatigueGeneral disorders	73/129	59/128	65/144	56/145
MyalgiaMusculoskeletal and connective tissue disorders	68/129	51/128	64/144	54/145
ErythemaSkin and subcutaneous tissue disorders	41/129	34/128	52/144	42/145
SwellingGeneral disorders	38/129	21/128	47/144	39/145
ArthralgiaMusculoskeletal and connective tissue disorders	41/129	38/128	31/144	34/145
Gastrointestinal disorderGastrointestinal disorders	41/129	35/128	28/144	26/145
PyrexiaGeneral disorders	24/129	20/128	23/144	25/145
UrticariaSkin and subcutaneous tissue disorders	14/129	9/128	4/144	6/145

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group	Total
Mean	20.4 ± 3.4	20.1 ± 3.5	19.3 ± 3.0	19.6 ± 3.0	19.8 ± 3.2

Sex: Female, Male
Sex: Female, Male(Participants)	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group	Total
Female	129	128	144	145	546
Male	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	HIV+/Cervarix Group	HIV+/Gardasil Group	HIV-/Cervarix Group	HIV-/Gardasil Group	Total
African Heritage/African American	10	6	4	4	24
Asian - Central/South Asian Heritage	20	18	67	68	173
Asian - East Asian Heritage	3	2	1	0	6
Asian - Japanese Heritage	0	0	1	2	3
Asian - South East Asian Heritage	40	44	39	42	165
White - Arabic/North African Heritage	17	12	7	6	42
White - Caucasian/European Heritage	33	37	24	19	113
Unspecified	6	9	1	4	20

Study locations

15 sites

GSK Investigational Site
Porto Alegre, Rio Grande Do Sul 90035003, Brazil
GSK Investigational Site
Ribeirão Preto, São Paulo 14049-900, Brazil
GSK Investigational Site
Campinas, 13083-970, Brazil
GSK Investigational Site
Rio de Janeiro, 21040-360, Brazil
GSK Investigational Site
São Paulo, 03015000, Brazil
GSK Investigational Site
Kohtla-Järve, 30322, Estonia
GSK Investigational Site
Tallinn, 10617, Estonia
GSK Investigational Site
Chennai, 600113, India
GSK Investigational Site
Kolkata, 700026, India
GSK Investigational Site
Mumbai, 400014, India
GSK Investigational Site
Pune, 411001, India
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Chiangmai, 50200, Thailand
GSK Investigational Site
Khon Kaen, 40002, Thailand

References and documents

Publications

Folschweiller N, Teixeira J, Joshi S, Goldani LZ, Supparatpinyo K, Basu P, Chotpitayasunondh T, Chetchotisakd P, Ruxrungtham K, Roteli-Martins C, Grinsztejn B, Quintana SM, Kumarasamy N, Poongulali S, Kulkarni V, Lin L, Datta SK, Descamps D, Dodet M, Dubin G, Friel D, Hezareh M, Karkada N, Meric Camilleri D, Poncelet S, Salaun B, Tavares-da-Silva F, Thomas-Jooris F, Struyf F. Immunogenicity and safety of the AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines in asymptomatic young women living with HIV aged 15-25 years: A phase IV randomized comparative study. EClinicalMedicine. 2020 May 25;23:100353. doi: 10.1016/j.eclinm.2020.100353. eCollection 2020 Jun. PubMed 32639485 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01031069
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Dec 14, 2009
Start date: Oct 26, 2010
Primary completion: Jan 13, 2016
Completion: Apr 19, 2017
Results posted: Jul 24, 2019
Last update: Jul 21, 2020

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

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FDA-regulated drug: No

View the source record on ClinicalTrials.gov ↗

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