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CompletedNCT00231413Updated Dec 12, 2019Results posted

Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

A Phase 2 interventional study of HPV 16/18 L1 AS04 and HPV-16/18/31/45 L1 AS04 Formulation 1 in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 11 sites in 2 countries. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2005, registered Oct 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
383
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study summary

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

02

Conditions studied

  • Infections, Papillomavirus
03

In context

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.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • A woman between, and including, 18 and 25 years of age at the time of the first vaccination
  • Written informed consent from the subject prior to enrolment
  • Subject must be free of obvious health problems
  • Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding
  • A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
  • Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
  • Previous vaccination against human papillomavirus (HPV)
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
383 participants (actual)

Study arms

  • Active comparator
    HPV-16/18 Group

    Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV 16/18 L1 AS04

  • Experimental
    HPV-TETRA A Group

    Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV-16/18/31/45 L1 AS04 Formulation 1

  • Experimental
    HPV-TETRA B Group

    Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV-16/18/31/45 L1 AS04 Formulation 2

  • Experimental
    HPV-TETRA C Group

    Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV-16/18/31/45 L1 AS04 Formulation 3

  • Experimental
    HPV-TETRA D Group

    Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV-16/18/31/45 L1 AS04 Formulation 4

  • Experimental
    HPV-TETRA E Group

    Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV-16/18/31/45 L1 AS04 Formulation 5

  • Experimental
    HPV-TETRA F Group

    Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

    Biological: HPV-16/18/31/45 L1 AS04 Formulation 6

Interventions

  • BiologicalHPV 16/18 L1 AS04

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

  • BiologicalHPV-16/18/31/45 L1 AS04 Formulation 1

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

  • BiologicalHPV-16/18/31/45 L1 AS04 Formulation 2

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

  • BiologicalHPV-16/18/31/45 L1 AS04 Formulation 3

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

  • BiologicalHPV-16/18/31/45 L1 AS04 Formulation 4

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

  • BiologicalHPV-16/18/31/45 L1 AS04 Formulation 5

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

  • BiologicalHPV-16/18/31/45 L1 AS04 Formulation 6

    3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

06

What researchers measure

Primary outcomes

  1. Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7

    Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

    Time frame: At Month 7

  2. Number of Seroconverted Subjects for Anti-HPV-18 at Month 7

    Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.

    Time frame: At Month 7

  3. Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7

    Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.

    Time frame: At Month 7

  4. Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7

    Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

    Time frame: At Month 7

Secondary outcomes

  1. Number of Seroconverted Subjects for Anti-HPV-16 at Month 2

    Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.

    Time frame: At Month 2

  2. Number of Seroconverted Subjects for Anti-HPV-18 at Month 2

    Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.

    Time frame: At Month 2

  3. Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2

    Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

    Time frame: At Month 2

  4. Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2

    Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

    Time frame: At Month 2

  5. Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7

    Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.

    Time frame: At Month 2 and Month 7

  6. Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7

    Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.

    Time frame: At Month 2 and Month 7

  7. Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7

    Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

    Time frame: At Month 2 and Month 7

  8. Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7

    Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

    Time frame: At Month 2 and Month 7

  9. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.

    Time frame: During the 7 day post-vaccination period following each dose and across doses

  10. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.

    Time frame: During the 7 day post-vaccination period following each dose and across doses

  11. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.

    Time frame: During the 30-day post-vaccination period

  12. Number of Subjects With Any Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.

    Time frame: From Day 0 to Month 7

  13. Number of Subjects With Any SAEs During the Extended Safety Follow-up

    SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.

    Time frame: From Day 0 to Month 12

  14. Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

    Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.

    Time frame: From Day 0 to Month 12

  15. Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)

    NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.

    Time frame: From Day 0 up to Month 12

  16. Number of Subjects Reporting Medically Significant Conditions

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

    Time frame: From Day 0 up to Month 12

  17. Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters

    The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological \[basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA\]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.

    Time frame: At Month 2 and Month 7

07

Results

Posted Dec 12, 2019

Participant flow

Participant flow — Overall Study
MilestoneHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Started88504948485050
Completed80454245454546
Not completed8573354
Withdrew: Non-serious ae0010001
Withdrew: Withdrawal by subject3142203
Withdrew: Migrated/moved from study area0010010
Withdrew: Lost to follow-up4411140
Withdrew: Pregnancy1000000

Outcome measures

PrimaryNumber of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7

Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame:
At Month 7
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 762273123332833
PrimaryNumber of Seroconverted Subjects for Anti-HPV-18 at Month 7

Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.

Time frame:
At Month 7
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Seroconverted Subjects for Anti-HPV-18 at Month 759303734273336
PrimaryAnti-HPV-16 Antibody Titers Assessed by ELISA at Month 7

Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.

Time frame:
At Month 7
Reported as:
Geometric mean · EL.U/mL
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
EL.U/mLHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 79086.1 (7231.1 to 11417.1)5757.4 (4283.9 to 7737.8)7897.7 (5825.2 to 10707.6)7524.1 (5678.1 to 9970.2)5986.4 (4485.2 to 7990.2)8483.5 (6257.6 to 11501.1)7605.0 (5818.7 to 9939.6)
PrimaryAnti-HPV-18 Antibody Titers Assessed by ELISA at Month 7

Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

Time frame:
At Month 7
Reported as:
Geometric mean · EL.U/mL
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
EL.U/mLHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 75184.5 (4211.1 to 6382.8)3061.3 (2231.7 to 4199.4)3640.2 (2590.4 to 5115.6)3268.6 (2650.4 to 4031.1)2998.5 (2109.5 to 4262.1)3296.2 (2402.8 to 4521.8)3056.0 (2364.5 to 3949.5)
SecondaryNumber of Seroconverted Subjects for Anti-HPV-16 at Month 2

Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.

Time frame:
At Month 2
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Seroconverted Subjects for Anti-HPV-16 at Month 262273123332833
SecondaryNumber of Seroconverted Subjects for Anti-HPV-18 at Month 2

Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.

Time frame:
At Month 2
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Seroconverted Subjects for Anti-HPV-18 at Month 259303734273336
SecondaryAnti-HPV-16 Antibody Titers Assessed by ELISA at Month 2

Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

Time frame:
At Month 2
Reported as:
Geometric mean · EL.U/mL
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
EL.U/mLHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 23256.7 (2613.6 to 4058.0)2718.9 (2207.9 to 3348.1)2779.4 (2139.2 to 3611.2)2915.5 (2346.9 to 3621.9)2353.5 (1782.0 to 3108.2)3202.3 (2539.5 to 4038.0)2720.9 (2226.8 to 3324.6)
SecondaryAnti-HPV-18 Antibody Titers Assessed by ELISA at Month 2

Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

Time frame:
At Month 2
Reported as:
Geometric mean · EL.U/mL
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
EL.U/mLHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 22530.1 (2007.0 to 3189.5)1731.5 (1311.6 to 2285.9)1875.9 (1464.0 to 2403.7)2082.2 (1682.3 to 2577.2)2048.8 (1566.9 to 2678.8)2003.1 (1575.4 to 2547.0)1820.0 (1412.2 to 2345.6)
SecondaryNumber of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7

Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.

Time frame:
At Month 2 and Month 7
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Month 254323729313036
Month 761323729313036
SecondaryNumber of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7

Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.

Time frame:
At Month 2 and Month 7
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Month 254333127323435
Month 756333127323435
SecondaryAnti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7

Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

Time frame:
At Month 2 and Month 7
Reported as:
Geometric mean · EL.U/mL
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
EL.U/mLHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Month 2232.8 (178.0 to 304.5)3694.6 (2720.2 to 5018.0)6271.3 (4762.4 to 8258.3)4570.7 (3636.0 to 5745.6)5114.8 (3967.7 to 6593.5)4846.7 (3817.6 to 6153.3)5627.6 (4650.8 to 6809.6)
Month 7920.5 (705.8 to 1200.6)7909.0 (5712.3 to 10950.4)14957.8 (11096.1 to 20163.5)9688.5 (7660.9 to 12252.7)11768.3 (8598.0 to 16107.6)9139.9 (6334.9 to 13186.9)12652.0 (10052.5 to 15923.6)
SecondaryAnti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7

Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

Time frame:
At Month 2 and Month 7
Reported as:
Geometric mean · EL.U/mL
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
EL.U/mLHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Month 2317.4 (246.2 to 409.2)1550.7 (1158.1 to 2076.5)2613.9 (1980.7 to 3449.5)1893.7 (1513.2 to 2369.8)2113.3 (1602.9 to 2786.4)2217.4 (1763.8 to 2787.7)2208.9 (1718.5 to 2839.4)
Month 7915.7 (732.1 to 1145.3)4719.4 (3631.1 to 6133.9)7923.1 (5902.7 to 10635.0)5851.8 (4400.7 to 7781.4)6027.6 (4463.6 to 8139.4)6266.4 (4514.6 to 8698.1)6149.5 (4805.2 to 7869.8)
SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.

Time frame:
During the 7 day post-vaccination period following each dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Any Pain - Dose 181454445444946
Grade 3 Pain - Dose 16656557
Any Pain - Dose 270424042404345
Grade 3 Pain - Dose 22334443
Any Pain - Dose 368403340374039
Grade 3 Pain - Dose 376310767
Any Pain - Across doses81484645445047
Grade 3 Pain - Across doses1012714111212
Any Redness - Dose 12010812151811
Grade 3 Redness - Dose 11000000
Any Redness - Dose 22118910141513
Grade 3 Redness - Dose 20000000
Any Redness - Dose 322171215131313
Grade 3 Redness - Dose 30000001
Any Redness - Across doses36281522242225
Grade 3 Redness - Across doses1000001
Any Swelling - Dose 11710686149
Grade 3 Swelling - Dose 11000000
Any Swelling - Dose 217113616186
Grade 3 Swelling - Dose 21000220
Any Swelling - Dose 32314811151611
Grade 3 Swelling - Dose 31001110
Any Swelling - Across doses33221218212719
Grade 3 Swelling - Across doses2001220
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.

Time frame:
During the 7 day post-vaccination period following each dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Any Artharlgia - Dose 166461054
Grade 3 Arthralgia - Dose 11000200
Related Arthralgia - Dose 12524734
Any Artharlgia - Dose 241134235
Grade 3 Arthralgia - Dose 20010010
Related Arthralgia - Dose 221032114
Any Artharlgia - Dose 33474237
Grade 3 Arthralgia - Dose 31010100
Related Arthralgia - Dose 32354225
Any Artharlgia - Across doses111391111911
Grade 3 Arthralgia - Across doses2020310
Related Arthralgia - Across doses51279959
Any Fatigue - Dose 137232419202725
Grade 3 Fatigue - Dose 10221122
Related Fatigue - Dose 12613168152220
Any Fatigue - Dose 232191318192116
Grade 3 Fatigue - Dose 21232310
Related Fatigue - Dose 222141010141611
Any Fatigue - Dose 328161518142220
Grade 3 Fatigue - Dose 30111321
Related Fatigue - Dose 318151114121614
Any Fatigue - Across doses54333032253431
Grade 3 Fatigue - Across doses1463553
Related Fatigue - Across doses42282422222727
Any Fever - Dose 14221411
Grade 3 Fever - Dose 10000000
Related Fever - Dose 12201301
Any Fever - Dose 22223321
Grade 3 Fever - Dose 20000000
Related Fever - Dose 21212311
Any Fever - Dose 37111411
Grade 3 Fever - Dose 30000000
Related Fever - Dose 33101411
Any Fever - Across doses10443942
Grade 3 Fever - Across doses0000000
Related Fever - Across doses5413922
Any Gastrointestinal - Dose 12510131091013
Grade 3 Gastrointestinal - Dose 11010001
Related Gastrointestinal - Dose 114463857
Any Gastrointestinal - Dose 21610866104
Grade 3 Gastrointestinal - Dose 21110200
Related Gastrointestinal - Dose 27641382
Any Gastrointestinal - Dose 317576876
Grade 3 Gastrointestinal - Dose 32002110
Related Gastrointestinal - Dose 35154424
Any Gastrointestinal - Across doses36151820171718
Grade 3 Gastrointestinal - Across doses4122211
Related Gastrointestinal - Across doses188128101011
Any Headache - Dose 132111624172913
Grade 3 Headache - Dose 12101111
Related Headache - Dose 11986913189
Any Headache - Dose 22117914121919
Grade 3 Headache - Dose 21211112
Related Headache - Dose 215127891411
Any Headache - Dose 3241281491818
Grade 3 Headache - Dose 33010230
Related Headache - Dose 314105661513
Any Headache - Across doses45242331223327
Grade 3 Headache - Across doses5322252
Related Headache - Across doses32171516192521
Any Myalgia - Dose 12014118111410
Grade 3 Myalgia - Dose 10134011
Related Myalgia - Dose 114119511109
Any Myalgia - Dose 2121179957
Grade 3 Myalgia - Dose 21011010
Related Myalgia - Dose 281175845
Any Myalgia - Dose 31011117878
Grade 3 Myalgia - Dose 31011111
Related Myalgia - Dose 381195667
Any Myalgia - Across doses25181916171915
Grade 3 Myalgia - Across doses2135122
Related Myalgia - Across doses20161613151413
Any Rash - Dose 14111411
Grade 3 Rash - Dose 10000000
Related Rash - Dose 10000311
Any Rash - Dose 23210030
Grade 3 Rash - Dose 20000000
Related Rash - Dose 23010020
Any Rash - Dose 31111102
Grade 3 Rash - Dose 30000000
Related Rash - Dose 31101101
Any Rash - Across doses6422432
Grade 3 Rash - Across doses0000000
Related Rash - Across doses3111422
Any Urticaria - Dose 11130012
Grade 3 Urticaria - Dose 10000000
Related Urticaria - Dose 11120012
Any Urticaria - Dose 20010000
Grade 3 Urticaria - Dose 20000000
Related Urticaria - Dose 20010000
Any Urticaria - Dose 32110001
Grade 3 Urticaria - Dose 30000000
Related Urticaria - Dose 32100001
Any Urticaria - Across doses3230013
Grade 3 Urticaria - Across doses0000000
Related Urticaria - Across doses3220013
SecondaryNumber of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.

Time frame:
During the 30-day post-vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Any AEs60313425323629
Grade 3 AEs14583568
Related AEs171676989
SecondaryNumber of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.

Time frame:
From Day 0 to Month 7
Reported as:
Count of participants · Participants
Number of Subjects With Any Serious Adverse Events (SAEs)
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Subjects With Any Serious Adverse Events (SAEs)1202100
SecondaryNumber of Subjects With Any SAEs During the Extended Safety Follow-up

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.

Time frame:
From Day 0 to Month 12
Reported as:
Count of participants · Participants
Number of Subjects With Any SAEs During the Extended Safety Follow-up
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Subjects With Any SAEs During the Extended Safety Follow-up2213200
SecondaryNumber of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.

Time frame:
From Day 0 to Month 12
Reported as:
Count of participants · Participants
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Healthy baby0021012
Spontaneous abortion0000100
Elective abortion1000000
SecondaryNumber of Subjects Reporting New Onset of Chronic Diseases (NOCDs)

NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.

Time frame:
From Day 0 up to Month 12
Reported as:
Count of participants · Participants
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)5161312
SecondaryNumber of Subjects Reporting Medically Significant Conditions

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

Time frame:
From Day 0 up to Month 12
Reported as:
Count of participants · Participants
Number of Subjects Reporting Medically Significant Conditions
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Number of Subjects Reporting Medically Significant Conditions2112200
SecondaryNumber of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters

The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological \[basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA\]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.

Time frame:
At Month 2 and Month 7
Reported as:
Count of participants · Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ParticipantsHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
ALAT, Normal (pre-vacc) - Normal (Month 2)78434244424746
ALAT, Normal (pre-vacc) - Below (Month 2)0000000
ALAT, Normal (pre-vacc) - Above (Month 2)2201210
ALAT, Normal (pre-vacc) - Missing (Month 2)1000100
ALAT, Normal (pre-vacc) - Normal (Month 7)78444044414145
ALAT, Normal (pre-vacc) - Below (Month 7)0000000
ALAT, Normal (pre-vacc) - Above (Month 7)0011310
ALAT, Normal (pre-vacc) - Missing (Month 7)0000010
ALAT, Above (pre-vacc) - Normal (Month 2)2110020
ALAT, Above (pre-vacc) - Below (Month 2)0000000
ALAT, Above (pre-vacc) - Above (Month 2)0000100
ALAT, Above (pre-vacc) - Normal (Month 7)2110120
ALAT, Above (pre-vacc) - Below (Month 7)0000000
ALAT, Above (pre-vacc) - Above (Month 7)0000000
BAS, Normal (pre-vacc) - Normal (Month 2)80434242434845
BAS, Normal (pre-vacc) - Below (Month 2)0000000
BAS, Normal (pre-vacc) - Above (Month 2)0000000
BAS, Normal (pre-vacc) - Missing (Month 2)0000100
BAS, Normal (pre-vacc) - Normal (Month 7)76404041434344
BAS, Normal (pre-vacc) - Below (Month 7)0000000
BAS, Normal (pre-vacc) - Above (Month 7)1100000
BAS, Normal (pre-vacc) - Missing (Month 7)0111000
CREA, Normal (pre-vacc) - Normal (Month 2)78434243434743
CREA, Normal (pre-vacc) - Below (Month 2)0000000
CREA, Normal (pre-vacc) - Above (Month 2)1211023
CREA, Normal (pre-vacc) - Missing (Month 2)0000100
CREA, Normal (pre-vacc) - Normal (Month 7)73434243414443
CREA, Normal (pre-vacc) - Below (Month 7)0000000
CREA, Normal (pre-vacc) - Above (Month 7)3101202
CREA, Above (pre-vacc) - Normal (Month 2)3000110
CREA, Above (pre-vacc) - Below (Month 2)0000000
CREA, Above (pre-vacc) - Above (Month 2)1101100
CREA, Above (pre-vacc) - Normal (Month 7)3000110
CREA, Above (pre-vacc) - Below (Month 7)0000000
CREA, Above (pre-vacc) - Above (Month 7)1101100
EOS, Normal (pre-vacc) - Normal (Month 2)67404238394541
EOS, Normal (pre-vacc) - Below (Month 2)3101011
EOS, Normal (pre-vacc) - Above (Month 2)3000303
EOS, Normal (pre-vacc) - Missing (Month 2)0000100
EOS, Normal (pre-vacc) - Normal (Month 7)63384038403843
EOS, Normal (pre-vacc) - Below (Month 7)3000021
EOS, Normal (pre-vacc) - Above (Month 7)4101210
EOS, Normal (pre-vacc) - Missing (Month 7)0110000
EOS, Above (pre-vacc) - Normal (Month 2)4000020
EOS, Above (pre-vacc) - Below (Month 2)0000000
EOS, Above (pre-vacc) - Above (Month 2)0001001
EOS, Above (pre-vacc) - Normal (Month 7)4000010
EOS, Above (pre-vacc) - Below (Month 7)0000000
EOS, Above (pre-vacc) - Above (Month 7)0001011
EOS, Below (pre-vacc) - Normal (Month 2)3102100
EOS, Below (pre-vacc) - Below (Month 2)0100000
EOS, Below (pre-vacc) - Above (Month 2)0000000
EOS, Below (pre-vacc) - Normal (Month 7)1102100
EOS, Below (pre-vacc) - Below (Month 7)2100000
EOS, Below (pre-vacc) - Above (Month 7)0000000
HCT, Normal (pre-vacc) - Normal (Month 2)73394140394541
HCT, Normal (pre-vacc) - Below (Month 2)0200120
HCT, Normal (pre-vacc) - Above (Month 2)2000221
HCT, Normal (pre-vacc) - Missing (Month 2)0000100
HCT, Normal (pre-vacc) - Normal (Month 7)71384040414339
HCT, Normal (pre-vacc) - Below (Month 7)1200010
HCT, Normal (pre-vacc) - Above (Month 7)0000102
HCT, Normal (pre-vacc) - Missing (Month 7)0100000
HCT, Above (pre-vacc) - Normal (Month 2)4222102
HCT, Above (pre-vacc) - Below (Month 2)0000000
HCT, Above (pre-vacc) - Above (Month 2)2100001
HCT, Above (pre-vacc) - Normal (Month 7)5322002
HCT, Above (pre-vacc) - Below (Month 7)0000000
HCT, Above (pre-vacc) - Above (Month 7)1000101
HCT, Below (pre-vacc) - Normal (Month 2)1203201
HCT, Below (pre-vacc) - Below (Month 2)1000010
HCT, Below (pre-vacc) - Above (Month 2)0000000
HCT, Below (pre-vacc) - Normal (Month 7)2002200
HCT, Below (pre-vacc) - Below (Month 7)0101011
HCT, Below (pre-vacc) - Above (Month 7)0000000
LYM, Normal (pre-vacc) - Normal (Month 2)70383639384040
LYM, Normal (pre-vacc) - Below (Month 2)1100120
LYM, Normal (pre-vacc) - Above (Month 2)2210132
LYM, Normal (pre-vacc) - Missing (Month 2)0000100
LYM, Normal (pre-vacc) - Normal (Month 7)65353438393739
LYM, Normal (pre-vacc) - Below (Month 7)2110011
LYM, Normal (pre-vacc) - Above (Month 7)2311121
LYM, Normal (pre-vacc) - Missing (Month 7)1100000
LYM, Above (pre-vacc) - Normal (Month 2)3142120
LYM, Above (pre-vacc) - Below (Month 2)0000000
LYM, Above (pre-vacc) - Above (Month 2)2000101
LYM, Above (pre-vacc) - Normal (Month 7)2131120
LYM, Above (pre-vacc) - Below (Month 7)0000000
LYM, Above (pre-vacc) - Above (Month 7)3011101
LYM, Below (pre-vacc) - Normal (Month 2)2110113
LYM, Below (pre-vacc) - Below (Month 2)0001000
LYM, Below (pre-vacc) - Above (Month 2)0000000
LYM, Below (pre-vacc) - Normal (Month 7)1110113
LYM, Below (pre-vacc) - Below (Month 7)1001000
LYM, Below (pre-vacc) - Above (Month 7)0000000
MONO, Normal (pre-vacc) - Normal (Month 2)68343631364037
MONO, Normal (pre-vacc) - Below (Month 2)6334325
MONO, Normal (pre-vacc) - Above (Month 2)1102120
MONO, Normal (pre-vacc) - Missing (Month 2)1000100
MONO, Normal (pre-vacc) - Normal (Month 7)69353432353539
MONO, Normal (pre-vacc) - Below (Month 7)3042431
MONO, Normal (pre-vacc) - Above (Month 7)0203211
MONO, Normal (pre-vacc) - Missing (Month 7)1100000
MONO, Above (pre-vacc) - Normal (Month 2)0130000
MONO, Above (pre-vacc) - Below (Month 2)0000000
MONO, Above (pre-vacc) - Above (Month 2)1001011
MONO, Above (pre-vacc) - Normal (Month 7)1130000
MONO, Above (pre-vacc) - Below (Month 7)0000000
MONO, Above (pre-vacc) - Above (Month 7)0001011
MONO, Below (pre-vacc) - Normal (Month 2)1204211
MONO, Below (pre-vacc) - Below (Month 2)2200122
MONO, Below (pre-vacc) - Above (Month 2)0000000
MONO, Below (pre-vacc) - Normal (Month 7)1203222
MONO, Below (pre-vacc) - Below (Month 7)2101011
MONO, Below (pre-vacc) - Above (Month 7)0000000
NEU, Normal (pre-vacc) - Normal (Month 2)63393936404241
NEU, Normal (pre-vacc) - Below (Month 2)7103131
NEU, Normal (pre-vacc) - Above (Month 2)3011000
NEU, Normal (pre-vacc) - Missing (Month 2)1000100
NEU, Normal (pre-vacc) - Normal (Month 7)69353837403839
NEU, Normal (pre-vacc) - Below (Month 7)2303101
NEU, Normal (pre-vacc) - Above (Month 7)0010021
NEU, Normal (pre-vacc) - Missing (Month 7)1100000
NEU, Above (pre-vacc) - Normal (Month 2)3221133
NEU, Above (pre-vacc) - Below (Month 2)0000000
NEU, Above (pre-vacc) - Above (Month 2)0000000
NEU, Above (pre-vacc) - Normal (Month 7)2221133
NEU, Above (pre-vacc) - Below (Month 7)0000000
NEU, Above (pre-vacc) - Above (Month 7)0000000
NEU, Below (pre-vacc) - Normal (Month 2)2101101
NEU, Below (pre-vacc) - Below (Month 2)1000000
NEU, Below (pre-vacc) - Above (Month 2)0000000
NEU, Below (pre-vacc) - Normal (Month 7)1101100
NEU, Below (pre-vacc) - Below (Month 7)2000001
NEU, Below (pre-vacc) - Above (Month 7)0000000
PLA, Normal (pre-vacc) - Normal (Month 2)74434041434643
PLA, Normal (pre-vacc) - Below (Month 2)0000000
PLA, Normal (pre-vacc) - Above (Month 2)1110100
PLA, Normal (pre-vacc) - Missing (Month 2)0000100
PLA, Normal (pre-vacc) - Normal (Month 7)70423941434042
PLA, Normal (pre-vacc) - Below (Month 7)0000000
PLA, Normal (pre-vacc) - Above (Month 7)3010110
PLA, Normal (pre-vacc) - Missing (Month 7)0100000
PLA, Above (pre-vacc) - Normal (Month 2)4212023
PLA, Above (pre-vacc) - Below (Month 2)0000000
PLA, Above (pre-vacc) - Above (Month 2)3002120
PLA, Above (pre-vacc) - Normal (Month 7)1102012
PLA, Above (pre-vacc) - Below (Month 7)0000000
PLA, Above (pre-vacc) - Above (Month 7)5112131
PLA, Below (pre-vacc) - Normal (Month 2)1000000
PLA, Below (pre-vacc) - Below (Month 2)0010000
PLA, Below (pre-vacc) - Above (Month 2)0000000
PLA, Below (pre-vacc) - Normal (Month 7)1010000
PLA, Below (pre-vacc) - Below (Month 7)0000000
PLA, Below (pre-vacc) - Above (Month 7)0000000
RBC, Normal (pre-vacc) - Normal (Month 2)83414241414741
RBC, Normal (pre-vacc) - Below (Month 2)0100221
RBC, Normal (pre-vacc) - Above (Month 2)0000001
RBC, Normal (pre-vacc) - Missing (Month 2)0000100
RBC, Normal (pre-vacc) - Normal (Month 7)78424141414342
RBC, Normal (pre-vacc) - Below (Month 7)1000110
RBC, Normal (pre-vacc) - Above (Month 7)1000100
RBC, Above (pre-vacc) - Normal (Month 2)0200001
RBC, Above (pre-vacc) - Below (Month 2)0000000
RBC, Above (pre-vacc) - Above (Month 2)0000000
RBC, Above (pre-vacc) - Normal (Month 7)0200001
RBC, Above (pre-vacc) - Below (Month 7)0000000
RBC, Above (pre-vacc) - Above (Month 7)0000000
RBC, Below (pre-vacc) - Normal (Month 2)0104211
RBC, Below (pre-vacc) - Below (Month 2)0110001
RBC, Below (pre-vacc) - Above (Month 2)0000000
RBC, Below (pre-vacc) - Normal (Month 7)0112211
RBC, Below (pre-vacc) - Below (Month 7)0002001
RBC, Below (pre-vacc) - Above (Month 7)0000000
WBC, Normal (pre-vacc) - Normal (Month 2)71373940414240
WBC, Normal (pre-vacc) - Below (Month 2)1100021
WBC, Normal (pre-vacc) - Above (Month 2)2121010
WBC, Normal (pre-vacc) - Missing (Month 2)0000100
WBC, Normal (pre-vacc) - Normal (Month 7)69363841383737
WBC, Normal (pre-vacc) - Below (Month 7)0110211
WBC, Normal (pre-vacc) - Above (Month 7)1010122
WBC, Normal (pre-vacc) - Missing (Month 7)1100000
WBC, Above (pre-vacc) - Normal (Month 2)3621224
WBC, Above (pre-vacc) - Below (Month 2)0000000
WBC, Above (pre-vacc) - Above (Month 2)1101030
WBC, Above (pre-vacc) - Normal (Month 7)3612234
WBC, Above (pre-vacc) - Below (Month 7)0000000
WBC, Above (pre-vacc) - Above (Month 7)1110020
WBC, Below (pre-vacc) - Normal (Month 2)4002201
WBC, Below (pre-vacc) - Below (Month 2)1000000
WBC, Below (pre-vacc) - Above (Month 2)0000000
WBC, Below (pre-vacc) - Normal (Month 7)3000201
WBC, Below (pre-vacc) - Below (Month 7)2002000
WBC, Below (pre-vacc) - Above (Month 7)0000000

Adverse events

Collected over Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HPV-16/18 Group0/88 (0%)2/88 (2.3%)81/88 (92%)
HPV-TETRA A Group0/50 (0%)2/50 (4%)48/50 (96%)
HPV-TETRA B Group0/49 (0%)1/49 (2%)46/49 (93.9%)
HPV-TETRA C Group0/48 (0%)3/48 (6.3%)45/48 (93.8%)
HPV-TETRA D Group0/48 (0%)2/48 (4.2%)44/48 (91.7%)
HPV-TETRA E Group0/50 (0%)0/50 (0%)50/50 (100%)
HPV-TETRA F Group0/50 (0%)0/50 (0%)47/50 (94%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
AppendicitisInfections and infestations0/881/500/491/480/480/500/50
MyelitisNervous system disorders0/880/500/491/480/480/500/50
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/880/500/490/481/480/500/50
CellulitisInfections and infestations0/880/500/490/481/480/500/50
PneumothoraxRespiratory, thoracic and mediastinal disorders0/880/500/491/480/480/500/50
Pre-eclampsiaPregnancy, puerperium and perinatal conditions0/880/501/490/480/480/500/50
Premature labourPregnancy, puerperium and perinatal conditions0/880/501/490/480/480/500/50
AstheniaGeneral disorders0/881/500/490/480/480/500/50
HeadacheNervous system disorders1/880/500/490/480/480/500/50
Major depressionPsychiatric disorders1/880/500/490/480/480/500/50
Most frequent other events
Showing 10 of 25
Most frequent other events
EventHPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F Group
Pain*General disorders81/8648/4946/4745/4644/4650/5047/48
Fatigue*General disorders54/8633/4930/4732/4625/4634/5031/48
Headache (solicited)*General disorders45/8624/4923/4731/4622/4633/5027/48
Redness*General disorders36/8628/4915/4722/4624/4622/5025/48
Swelling*General disorders33/8622/4912/4718/4621/4627/5019/48
Gastrointestinal*General disorders36/8615/4918/4720/4617/4617/5018/48
Myalgia*General disorders25/8618/4919/4716/4617/4619/5015/48
Arthralgia*General disorders11/8613/499/4711/4611/469/5011/48
Fever*General disorders10/864/494/473/469/464/502/48
Upper respiratory tract infection**Infections and infestations4/884/509/494/486/487/505/50

Baseline characteristics

Age, Continuous
Age, Continuous(Years)HPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F GroupTotal
Mean20.9 ± 2.0321.5 ± 2.1821.2 ± 2.0721.1 ± 2.0921.4 ± 2.2721.2 ± 2.2620.7 ± 1.9121.1 ± 2.10
Sex: Female, Male
Sex: Female, Male(Participants)HPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F GroupTotal
Female88504948485050383
Male00000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)HPV-16/18 GroupHPV-TETRA A GroupHPV-TETRA B GroupHPV-TETRA C GroupHPV-TETRA D GroupHPV-TETRA E GroupHPV-TETRA F GroupTotal
Black10111116
White/caucasian80504646424447355
Arabic/north african00000101
East/south east asian40002006
South asian00110103
American hispanic10101205
Japanese00001001
Other, not specified20001126
08

Study locations

11 sites
  • GSK Investigational Site
    Aurora, Colorado 80045, United States
  • GSK Investigational Site
    Golden, Colorado 80401, United States
  • GSK Investigational Site
    Kingston, Rhode Island 02881, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84109, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84121, United States
  • GSK Investigational Site
    Bruxelles, 1070, Belgium
  • GSK Investigational Site
    Gent, 9000, Belgium
  • GSK Investigational Site
    Leuven, 3000, Belgium
  • GSK Investigational Site
    Liège, 4000, Belgium
  • GSK Investigational Site
    Roeselare, 8800, Belgium
  • GSK Investigational Site
    Wilrijk, 2610, Belgium
09

References and documents

Publications

  • Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25. PubMed 24674663 ↗

Individual participant data

Plan to share: Yes — IPD is available via the Clinical Study Data Request site (click on the link provided below).

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00231413
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 4, 2005
Start date
Mar 4, 2005
Primary completion
Mar 27, 2006
Completion
Mar 27, 2006
Results posted
Dec 12, 2019
Last update
Dec 12, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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