A Phase 1 interventional study of Cervarix and Placebo in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 25 sites in 2 countries. Open to female participants aged 9 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention
Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.
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Exclusion Criteria:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Biological: Cervarix · Drug: Placebo
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Biological: Cervarix · Drug: Placebo
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Biological: Cervarix · Drug: Placebo
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Biological: Cervarix
Intramuscular injection, different dosing /schedule
Also known as: GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299
Intramuscular injection, different dosing /schedule
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (\>) 50 millimeters (mm).
Time frame: Within 7 days (Day 0-6) after vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.
Time frame: Within 7 days (Day 0-6) after vaccination.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.
Time frame: At Month 3, 1 month after the second dose of vaccine or placebo
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.
Time frame: At Month 7, 1 month after the last dose of vaccine or placebo.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 7, 1 month after the last dose of vaccine or placebo.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.
Time frame: At Month 7 (M7)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.
Time frame: At Month 7 (M7)
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.
Time frame: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
Time frame: At Month 60 of the safety follow-up phase
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.
Time frame: At Month 60 of the safety follow-up phase
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
Time frame: From Month 0 to Month 48.
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
Time frame: Throughout the study period, from Month 0 to Month 60.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.
Time frame: Within 30 days (Day 0-29) after vaccination.
Number of Subjects With Medically Significant Conditions (MSCs).
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Time frame: From Month 0 to Month 7.
Number of Subjects With Medically Significant Conditions (MSCs).
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Time frame: From Month 0 to Month 48.
Number of Subjects With Medically Significant Conditions (MSCs).
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Time frame: Throughout the study period, from Month 0 to Month 60.
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time frame: From Month 0 to Month 7.
Number of Subjects With New Onset of Autoimune Diseases (NOADs)
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time frame: From Month 0 to Month 48.
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time frame: Throughout the study period, from Month 0 to Month 60.
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time frame: From Month 0 to Month 7.
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time frame: From Month 0 to Month 48.
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time frame: Throughout the study period, from Month 0 to Month 60.
Number of Subjects With Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Month 0 to Month 7.
Number of Subjects With Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Month 0 to Month 48.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period, from Month 0 to Month 60.
The study included two phases, an active vaccination phase (Months 0-7) followed by a safety follow-up phase (up to the end of the study at Month 60).
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 231 | 228 | 229 | 234 |
| Not completed | 9 | 13 | 11 | 5 |
| Withdrew: Protocol violation | 9 | 13 | 11 | 5 |
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 228 | 219 | 219 | 223 |
| Not completed | 12 | 22 | 21 | 16 |
| Withdrew: Adverse event | 0 | 1 | 1 | 1 |
| Withdrew: Protocol violation | 12 | 21 | 20 | 15 |
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 226 | 217 | 215 | 222 |
| Not completed | 14 | 24 | 25 | 17 |
| Withdrew: Adverse event | 0 | 1 | 1 | 1 |
| Withdrew: Protocol violation | 14 | 23 | 24 | 16 |
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 211 | 209 | 208 | 217 |
| Not completed | 29 | 32 | 32 | 22 |
| Withdrew: Adverse event | 0 | 1 | 1 | 1 |
| Withdrew: Protocol violation | 29 | 31 | 31 | 21 |
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 179 | 175 | 174 | 179 |
| Not completed | 61 | 66 | 66 | 60 |
| Withdrew: Protocol violation | 61 | 66 | 66 | 60 |
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 169 | 168 | 167 | 164 |
| Not completed | 71 | 73 | 73 | 75 |
| Withdrew: Withdrawal by subject | 2 | 4 | 4 | 2 |
| Withdrew: Other | 3 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 66 | 68 | 68 | 73 |
| Milestone | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Started | 240 | 241 | 240 | 239 |
| Completed | 162 | 164 | 158 | 167 |
| Not completed | 78 | 77 | 82 | 72 |
| Withdrew: Protocol violation | 78 | 77 | 82 | 72 |
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
| EL.U/mL | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Anti-HPV-16 | 5844.6 (5259.6 to 6494.7) | 10500.9 (9356.9 to 11784.8) | 7741.6 (6868.2 to 8726.1) | 13045.3 (11211.4 to 15179.2) |
| Anti-HPV-18 | 3543.2 (3126.6 to 4015.3) | 5997.5 (5310.9 to 6772.8) | 4811.4 (4282.7 to 5405.3) | 5087.1 (4460.2 to 5802.1) |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (\>) 50 millimeters (mm).
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Any Pain | 222 | 225 | 222 | 225 |
| Grade 3 Pain | 18 | 27 | 26 | 35 |
| Any Redness | 109 | 112 | 123 | 145 |
| Redness > 50 mm | 3 | 4 | 1 | 3 |
| Any Swelling | 92 | 88 | 83 | 118 |
| Swelling > 50 mm | 4 | 3 | 1 | 5 |
Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Any Arthralgia | 45 | 57 | 39 | 43 |
| Related Arthralgia | 39 | 43 | 35 | 35 |
| Grade 3 Arthralgia | 0 | 3 | 4 | 3 |
| Any Fatigue | 100 | 109 | 104 | 107 |
| Related Fatigue | 76 | 82 | 87 | 83 |
| Grade 3 Fatigue | 11 | 4 | 5 | 8 |
| Any Fever (Axillary Temperature >= 37.5°C) | 23 | 20 | 22 | 39 |
| Related Fever | 18 | 15 | 16 | 27 |
| Grade 3 Fever (Axillary Temperature >= 39.0°C) | 1 | 0 | 1 | 0 |
| Any Gastrointestinal Symptoms | 48 | 48 | 36 | 68 |
| Related Gastrointestinal Symptoms | 36 | 43 | 27 | 50 |
| Grade 3 Gastrointestinal Symptoms | 3 | 7 | 2 | 7 |
| Any Headache | 101 | 116 | 112 | 125 |
| Related Headache | 79 | 81 | 91 | 95 |
| Grade 3 Headache | 9 | 9 | 7 | 12 |
| Any Myalgia | 79 | 109 | 98 | 99 |
| Related Myalgia | 62 | 87 | 75 | 77 |
| Grade 3 Myalgia | 3 | 9 | 6 | 7 |
| Any Rash | 12 | 12 | 10 | 15 |
| Related Rash | 8 | 9 | 8 | 9 |
| Grade 3 Rash | 0 | 0 | 1 | 1 |
| Any Urticaria | 2 | 4 | 4 | 5 |
| Related Urticaria | 1 | 3 | 4 | 3 |
| Grade 3 Urticaria | 0 | 0 | 1 | 0 |
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.
| EL.U/mL | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group |
|---|---|---|---|
| Anti-HPV-16 | 5844.6 (5259.6 to 6494.7) | 397.9 (337.4 to 469.2) | 266.4 (227.2 to 312.4) |
| Anti-HPV-18 | 3543.2 (3126.6 to 4015.3) | 228.3 (196.7 to 265.0) | 181.9 (156.8 to 211.1) |
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.
| EL.U/mL | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| 9-14 years, Anti-HPV-16 | 2003.9 (1635.7 to 2455.0) | 15028.4 (12611.3 to 17908.6) | 11058.6 (9273.8 to 13186.7) | 22066.3 (18140.7 to 26841.2) |
| 15-19 years, Anti-HPV-16 | 1168.5 (957.4 to 1426.2) | 10818.7 (8979.8 to 13034.2) | 7869.6 (6488.9 to 9543.9) | 12817.4 (9723.2 to 16896.2) |
| 20-25 years, Anti-HPV-16 | 1371.2 (1092.2 to 1721.6) | 7331.4 (5965.2 to 9010.4) | 5209.2 (4166.5 to 6512.7) | 7370.0 (5673.6 to 9573.6) |
| 9-14 years, Anti-HPV-18 | 1134.3 (922.8 to 1394.3) | 8085.8 (6654.5 to 9825.0) | 5630.7 (4772.1 to 6643.7) | 7192.9 (5952.6 to 8691.6) |
| 15-19 years, Anti-HPV-18 | 719.8 (571.2 to 907.0) | 6170.1 (5046.8 to 7543.5) | 5039.3 (4283.4 to 5928.5) | 4907.0 (3780.8 to 6368.7) |
| 20-25 years, Anti-HPV-18 | 656.5 (514.6 to 837.5) | 4389.6 (3525.6 to 5465.4) | 3889.2 (2980.9 to 5074.3) | 3576.8 (2886.5 to 4432.2) |
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
| EL.U/mL | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Anti-HPV-16 at Month 12 | 1064.7 (937.5 to 1209.1) | 3256.0 (2918.8 to 3632.1) | 2438.7 (2167.2 to 2744.2) | 4726.7 (4036.8 to 5534.6) |
| Anti-HPV-16 at Month 18 | 968.1 (845.2 to 1109.0) | 2229.4 (1983.2 to 2506.2) | 1659.1 (1466.9 to 1876.4) | 3185.1 (2735.1 to 3709.2) |
| Anti-HPV-16 at Month 24 | 821.2 (718.5 to 938.5) | 1756.4 (1556.6 to 1981.9) | 1285.1 (1139.6 to 1449.2) | 2425.9 (2071.1 to 2841.5) |
| Anti-HPV-16 at Month 36 | 688.3 (592.2 to 799.9) | 1462.2 (1288.8 to 1658.8) | 1094.0 (961.1 to 1245.1) | 2195.4 (1850.8 to 2604.1) |
| Anti-HPV-16 at Month 48 | 649.5 (556.0 to 758.8) | 1261.2 (1106.4 to 1437.7) | 953.5 (835.5 to 1088.2) | 1892.3 (1594.2 to 2246.0) |
| Anti-HPV-18 at Month 12 | 472.9 (410.5 to 544.8) | 1760.1 (1531.5 to 2022.8) | 1426.2 (1250.8 to 1626.1) | 1714.5 (1469.7 to 2000.0) |
| Anti-HPV-18 at Month 18 | 389.2 (338.7 to 447.2) | 1025.2 (889.0 to 1182.2) | 883.1 (774.7 to 1006.8) | 1096.6 (939.4 to 1280.1) |
| Anti-HPV-18 at Month 24 | 345.9 (299.3 to 399.8) | 818.2 (706.5 to 947.5) | 674.6 (591.8 to 769.0) | 866.8 (741.2 to 1013.6) |
| Anti-HPV-18 at Month 36 | 302.2 (254.9 to 358.2) | 712.8 (605.4 to 839.3) | 617.9 (532.3 to 717.2) | 874.2 (734.9 to 1040.0) |
| Anti-HPV-18 at Month 48 | 260.4 (218.5 to 310.2) | 626.3 (531.0 to 738.7) | 517.0 (446.2 to 599.1) | 723.2 (607.2 to 861.4) |
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
| EL.U/mL | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Anti-HPV-16 | 1677.5 (1677.5 to 1677.5) | 11784.8 (11784.8 to 11784.8) | 8726.1 (8726.1 to 8726.1) | 15179.2 (15179.2 to 15179.2) |
| Anti-HPV-18 | 817.3 (715.6 to 933.4) | 5997.5 (5310.9 to 6772.8) | 4811.4 (4282.7 to 5405.3) | 5087.1 (4460.2 to 5802.1) |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| BAS, PRE NORMAL, M7 NORMAL | 219 | 214 | 208 | 214 |
| BAS, PRE NORMAL, M7 BELOW | 0 | 0 | 0 | 0 |
| BAS, PRE NORMAL, M7 ABOVE | 2 | 3 | 6 | 3 |
| BAS, PRE NORMAL, M7 MISSING | 1 | 2 | 4 | 3 |
| BAS, PRE BELOW, M7 NORMAL | 0 | 0 | 1 | 0 |
| BAS, PRE BELOW, M7 BELOW | 0 | 0 | 0 | 1 |
| BAS, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| BAS, PRE ABOVE, M7 NORMAL | 1 | 2 | 2 | 4 |
| BAS, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| BAS, PRE ABOVE, M7 ABOVE | 0 | 0 | 0 | 0 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| CREA, PRE NORMAL, M7 NORMAL | 202 | 200 | 210 | 206 |
| CREA, PRE NORMAL, M7 BELOW | 7 | 4 | 3 | 6 |
| CREA, PRE NORMAL, M7 ABOVE | 5 | 7 | 1 | 4 |
| CREA, PRE NORMAL, M7 MISSING | 1 | 0 | 1 | 2 |
| CREA, PRE BELOW, M7 NORMAL | 6 | 3 | 3 | 2 |
| CREA, PRE BELOW, M7 BELOW | 2 | 4 | 4 | 3 |
| CREA, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| CREA, PRE BELOW, M7 MISSING | 0 | 0 | 0 | 1 |
| CREA, PRE ABOVE, M7 NORMAL | 2 | 4 | 4 | 2 |
| CREA, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| CREA, PRE ABOVE, M7 ABOVE | 1 | 3 | 2 | 3 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| EOS, PRE NORMAL, M7 NORMAL | 203 | 207 | 200 | 205 |
| EOS, PRE NORMAL, M7 BELOW | 0 | 0 | 0 | 0 |
| EOS, PRE NORMAL, M7 ABOVE | 5 | 6 | 8 | 6 |
| EOS, PRE NORMAL, M7 MISSING | 1 | 1 | 4 | 3 |
| EOS, PRE BELOW, M7 NORMAL | 0 | 1 | 0 | 0 |
| EOS, PRE BELOW, M7 BELOW | 0 | 1 | 1 | 0 |
| EOS, PRE BELOW, M7 ABOVE | 1 | 0 | 0 | 0 |
| EOS, PRE ABOVE, M7 NORMAL | 8 | 3 | 3 | 7 |
| EOS, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| EOS, PRE ABOVE, M7 ABOVE | 8 | 3 | 7 | 5 |
| EOS, PRE ABOVE, M7 MISSING | 0 | 1 | 0 | 0 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Hct, PRE NORMAL, M7 NORMAL | 196 | 193 | 189 | 208 |
| Hct, PRE NORMAL, M7 BELOW | 6 | 5 | 8 | 2 |
| Hct, PRE NORMAL, M7 ABOVE | 11 | 8 | 7 | 6 |
| Hct, PRE NORMAL, M7 MISSING | 2 | 2 | 4 | 1 |
| Hct, PRE BELOW, M7 NORMAL | 3 | 5 | 4 | 2 |
| Hct, PRE BELOW, M7 BELOW | 3 | 2 | 3 | 1 |
| Hct, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| Hct, PRE ABOVE, M7 NORMAL | 7 | 8 | 10 | 7 |
| Hct, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| Hct, PRE ABOVE, M7 ABOVE | 1 | 5 | 2 | 6 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| ALT, PRE NORMAL, M7 NORMAL | 211 | 211 | 213 | 209 |
| ALT, PRE NORMAL, M7 BELOW | 3 | 2 | 4 | 4 |
| ALT, PRE NORMAL, M7 ABOVE | 1 | 6 | 7 | 5 |
| ALT, PRE NORMAL, M7 MISSING | 0 | 0 | 1 | 0 |
| ALT, PRE BELOW, M7 NORMAL | 0 | 2 | 0 | 2 |
| ALT, PRE BELOW, M7 BELOW | 1 | 1 | 1 | 2 |
| ALT, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| ALT, PRE ABOVE, M7 NORMAL | 9 | 4 | 1 | 7 |
| ALT, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| ALT, PRE ABOVE, M7 ABOVE | 4 | 1 | 2 | 3 |
| ALT, PRE ABOVE, M7 MISSING | 0 | 0 | 0 | 1 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| LYM, PRE NORMAL, M7 NORMAL | 201 | 202 | 192 | 202 |
| LYM, PRE NORMAL, M7 BELOW | 3 | 0 | 3 | 1 |
| LYM, PRE NORMAL, M7 ABOVE | 6 | 7 | 5 | 7 |
| LYM, PRE NORMAL, M7 MISSING | 1 | 2 | 4 | 3 |
| LYM, PRE BELOW, M7 NORMAL | 4 | 3 | 3 | 1 |
| LYM, PRE BELOW, M7 BELOW | 2 | 0 | 2 | 2 |
| LYM, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 2 |
| LYM, PRE ABOVE, M7 NORMAL | 5 | 7 | 8 | 5 |
| LYM, PRE ABOVE, M7 BELOW | 0 | 0 | 1 | 0 |
| LYM, PRE ABOVE, M7 ABOVE | 4 | 2 | 5 | 4 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| MON, PRE NORMAL, M7 NORMAL | 212 | 202 | 197 | 208 |
| MON, PRE NORMAL, M7 BELOW | 0 | 1 | 2 | 2 |
| MON, PRE NORMAL, M7 ABOVE | 4 | 6 | 9 | 6 |
| MON, PRE NORMAL, M7 MISSING | 1 | 2 | 3 | 3 |
| MON, PRE BELOW, M7 NORMAL | 1 | 1 | 0 | 2 |
| MON, PRE BELOW, M7 BELOW | 2 | 1 | 0 | 0 |
| MON, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| MON, PRE ABOVE, M7 NORMAL | 5 | 6 | 6 | 4 |
| MON, PRE ABOVE], M7 BELOW | 0 | 0 | 0 | 0 |
| MON, PRE ABOVE, M7 ABOVE | 1 | 4 | 5 | 2 |
| MON, PRE ABOVE, M7 MISSING | 0 | 0 | 1 | 0 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| NEU, PRE NORMAL, M7 NORMAL | 184 | 188 | 185 | 186 |
| NEU, PRE NORMAL, M7 BELOW | 16 | 16 | 9 | 9 |
| NEU, PRE NORMAL, M7 ABOVE | 5 | 1 | 1 | 3 |
| NEU, PRE NORMAL, M7 MISSING | 1 | 2 | 7 | 6 |
| NEU, PRE BELOW, M7 NORMAL | 8 | 6 | 9 | 15 |
| NEU, PRE BELOW, M7 BELOW | 2 | 4 | 7 | 3 |
| NEU, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| NEU, PRE ABOVE, M7 NORMAL | 6 | 5 | 5 | 1 |
| NEU, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 2 |
| NEU, PRE ABOVE, M7 ABOVE | 1 | 0 | 0 | 0 |
| NEU, PRE BELOW, M7 MISSING | 1 | 1 | 0 | 1 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| RBC, PRE NORMAL, M7 NORMAL | 204 | 204 | 196 | 213 |
| RBC, PRE NORMAL, M7 BELOW | 7 | 7 | 2 | 7 |
| RBC, PRE NORMAL, M7 ABOVE | 2 | 3 | 2 | 3 |
| RBC, PRE NORMAL, M7 MISSING | 1 | 1 | 4 | 2 |
| RBC, PRE BELOW, M7 NORMAL | 4 | 3 | 2 | 1 |
| RBC, PRE BELOW, M7 BELOW | 2 | 3 | 10 | 3 |
| RBC, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| RBC, PRE ABOVE, M7 NORMAL | 5 | 4 | 6 | 3 |
| RBC, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| RBC, PRE ABOVE, M7 ABOVE | 4 | 3 | 6 | 1 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| WBC, PRE NORMAL, M7 NORMAL | 197 | 199 | 194 | 212 |
| WBC, PRE NORMAL, M7 BELOW | 4 | 9 | 5 | 9 |
| WBC, PRE NORMAL, M7 ABOVE | 5 | 4 | 8 | 3 |
| WBC, PRE NORMAL, M7 MISSING | 1 | 1 | 4 | 1 |
| WBC, PRE BELOW, M7 NORMAL | 4 | 5 | 3 | 3 |
| WBC, PRE BELOW, M7 BELOW | 4 | 4 | 3 | 1 |
| WBC, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| WBC, PRE ABOVE, M7 NORMAL | 10 | 4 | 9 | 4 |
| WBC, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| WBC, PRE ABOVE, M7 ABOVE | 4 | 2 | 3 | 0 |
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| PLA, PRE NORMAL, M7 NORMAL | 204 | 204 | 206 | 218 |
| PLA, PRE NORMAL, M7 BELOW | 1 | 2 | 3 | 0 |
| PLA, PRE NORMAL, M7 ABOVE | 5 | 2 | 2 | 1 |
| PLA, PRE NORMAL, M7 MISSING | 1 | 2 | 4 | 2 |
| PLA, PRE BELOW, M7 NORMAL | 0 | 0 | 0 | 1 |
| PLA, PRE BELOW, M7 BELOW | 0 | 3 | 0 | 2 |
| PLA, PRE BELOW, M7 ABOVE | 0 | 0 | 0 | 0 |
| PLA, PRE ABOVE, M7 NORMAL | 9 | 11 | 8 | 4 |
| PLA, PRE ABOVE, M7 BELOW | 0 | 0 | 0 | 0 |
| PLA, PRE ABOVE, M7 ABOVE | 6 | 3 | 5 | 4 |
Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Anti-HPV-16 at Month 12 | 194 | 162 | 172 | 169 |
| Anti-HPV-16 at Month 18 | 192 | 166 | 172 | 168 |
| Anti-HPV-16 at Month 24 | 185 | 155 | 165 | 162 |
| Anti-HPV-16 at Month 36 | 156 | 135 | 146 | 135 |
| Anti-HPV-16 at Month 48 | 149 | 130 | 139 | 129 |
| Anti-HPV-18 at Month 12 | 187 | 173 | 166 | 173 |
| Anti-HPV-18 at Month 18 | 184 | 177 | 166 | 173 |
| Anti-HPV-18 at Month 24 | 173 | 165 | 159 | 166 |
| Anti-HPV-18 at Month 36 | 144 | 145 | 139 | 132 |
| Anti-HPV-18 at Month 48 | 138 | 139 | 135 | 129 |
Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
| EL.U/mL | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Anti-HPV-16 at Month 60 | 658.0 (560.4 to 772.5) | 1254.0 (1088.5 to 1444.8) | 976.1 (846.1 to 1126.1) | 1858.5 (1586.2 to 2177.6) |
| Anti-HPV-18 at Month 60 | 269.4 (223.0 to 325.5) | 622.2 (519.0 to 745.9) | 557.9 (473.7 to 657.0) | 745.3 (629.3 to 882.7) |
Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Anti-HPV-16 at Month 60 | 130 | 114 | 119 | 127 |
| Anti-HPV-18 at Month 60 | 116 | 122 | 116 | 125 |
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Ectopic pregnancy | 1 | 0 | 0 | 0 |
| Elective termination with NO ACA | 5 | 3 | 3 | 5 |
| Elective termination with CA | 0 | 0 | 1 | 0 |
| Live infant with NO ACA | 15 | 12 | 15 | 12 |
| Lost to follow up | 1 | 0 | 0 | 0 |
| Pregnancy ongoing | 0 | 1 | 2 | 2 |
| Spontaneous abortion with NO ACA | 1 | 0 | 3 | 1 |
Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Ectopic pregnancy | 1 | 0 | 0 | 1 |
| Elective termination NO apparent congenital anom. | 5 | 6 | 4 | 6 |
| Elective termination congenital anomaly | 0 | 0 | 1 | 0 |
| Live infant NO apparent congenital anomaly | 22 | 16 | 22 | 18 |
| Lost to follow up | 1 | 0 | 0 | 0 |
| Molar pregnancy | 1 | 0 | 0 | 0 |
| Spontaneous abortion NO apparent congenital anom. | 2 | 1 | 3 | 1 |
An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Any unsolicited AE(s) | 83 | 85 | 76 | 107 |
| Grade 3 unsolicited AE(s) | 11 | 8 | 6 | 14 |
| Related unsolicited AE(s) | 26 | 20 | 16 | 27 |
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With Medically Significant Conditions (MSCs). | 40 | 48 | 45 | 42 |
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With Medically Significant Conditions (MSCs). | 79 | 94 | 88 | 82 |
MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With Medically Significant Conditions (MSCs). | 85 | 97 | 92 | 89 |
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With New Onset of Autoimmune Diseases (NOADs) | 1 | 1 | 2 | 1 |
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With New Onset of Autoimune Diseases (NOADs) | 3 | 4 | 5 | 4 |
NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With New Onset of Autoimmune Diseases (NOADs) | 4 | 4 | 5 | 6 |
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With New Onset of Chronic Diseases (NOCDs) | 4 | 2 | 6 | 3 |
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With New Onset of Chronic Diseases (NOCDs) | 8 | 11 | 13 | 6 |
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With New Onset of Chronic Diseases (NOCDs) | 8 | 11 | 14 | 7 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs). | 4 | 4 | 4 | 2 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs). | 10 | 13 | 19 | 13 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| Participants | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 14 | 16 | 19 | 15 |
Collected over Serious adverse events: From Month 0 to Month 60. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix 1/Placebo Group | — | 14/240 (5.8%) | 229/240 (95.4%) |
| Cervarix 1/Placebo/Cervarix 1 Group | — | 16/241 (6.6%) | 233/241 (96.7%) |
| Cervarix 2/Placebo/Cervarix 2 Group | — | 19/240 (7.9%) | 228/240 (95%) |
| Cervarix 2 Group | — | 15/239 (6.3%) | 233/239 (97.5%) |
| Event | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| AppendicitisInfections and infestations | 0/240 | 2/241 | 4/240 | 1/239 |
| Abdominal painGastrointestinal disorders | 3/240 | 1/241 | 0/240 | 1/239 |
| TonsillitisInfections and infestations | 0/240 | 0/241 | 0/240 | 2/239 |
| Abortion spontaneous incompletePregnancy, puerperium and perinatal conditions | 0/240 | 0/241 | 2/240 | 1/239 |
| Umbilical hernia, obstructiveGastrointestinal disorders | 0/240 | 2/241 | 0/240 | 0/239 |
| Basedow's diseaseEndocrine disorders | 0/240 | 0/241 | 0/240 | 1/239 |
| Appendix disorderGastrointestinal disorders | 0/240 | 0/241 | 0/240 | 1/239 |
| Pharyngitis streptococcalInfections and infestations | 0/240 | 0/241 | 0/240 | 1/239 |
| Urinary tract infectionInfections and infestations | 1/240 | 0/241 | 0/240 | 1/239 |
| Ligament ruptureInjury, poisoning and procedural complications | 0/240 | 0/241 | 0/240 | 1/239 |
| Event | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group |
|---|---|---|---|---|
| PainGeneral disorders | 222/240 | 225/241 | 222/240 | 225/239 |
| RednessGeneral disorders | 109/240 | 112/241 | 123/240 | 145/239 |
| HeadacheGeneral disorders | 101/240 | 116/241 | 112/240 | 125/239 |
| SwellingGeneral disorders | 92/240 | 88/241 | 83/240 | 118/239 |
| FatigueGeneral disorders | 100/240 | 109/241 | 104/240 | 107/239 |
| MyalgiaGeneral disorders | 79/240 | 109/241 | 98/240 | 99/239 |
| GastrointestinalGeneral disorders | 48/240 | 48/241 | 36/240 | 68/239 |
| ArthralgiaGeneral disorders | 45/240 | 57/241 | 39/240 | 43/239 |
| FeverGeneral disorders | 23/240 | 20/241 | 22/240 | 39/239 |
| RashGeneral disorders | 12/240 | 12/241 | 10/240 | 15/239 |
| Age, Continuous(Years) | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group | Total |
|---|---|---|---|---|---|
| Mean | 17.1 ± 4.30 | 17.2 ± 4.30 | 17.3 ± 4.25 | 17.2 ± 4.38 | 17.2 ± 4.31 |
| Sex: Female, Male(Participants) | Cervarix 1/Placebo Group | Cervarix 1/Placebo/Cervarix 1 Group | Cervarix 2/Placebo/Cervarix 2 Group | Cervarix 2 Group | Total |
|---|---|---|---|---|---|
| Female | 240 | 241 | 240 | 239 | 960 |
| Male | 0 | 0 | 0 | 0 | 0 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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