Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00481767
• Collaborator: (none)
• Enrollment: 676
• Locations: 2
• Arms: 2
• Actual Duration (Months): 33.8
• Patients Per Site: 338
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries. The incidence of cervical cancer varies depending on the region of the world. Africa has some of the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7 and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8 per 100 000; Middle Africa 28.0 and 23.0 per 100 000).

As in the majority of developing countries, organization of cervical cancer screening programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic vaccination could therefore clearly and efficiently decrease the incidence of cervical cancer. The current study is designed to assess the immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in Africa.

Ideally, HPV vaccination should be performed before onset of sexual activity, since studies have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will therefore be performed in subjects aged 10 to 25 years of age.

Condition or Disease	Intervention/Treatment	Phase
Human Papillomavirus (HPV) Infection	Biological: Cervarix; Drug: Placebo Al(OH)3	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 676 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine GSK580299 in Healthy Female Subjects Aged 10-25 Years.
• Actual Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 25, 2010
• Actual Study Completion Date: Jul 26, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cervarix Group Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Biological: Cervarix; The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.; Other Names: GlaxoSmithKline Biologicals' HPV vaccine GSK580299 HPV-16/18 L1 AS04 vaccine
Placebo Comparator: Placebo Group Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Drug: Placebo Al(OH)3; Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.

Outcome Measures

Primary Outcome Measures

1. Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies [At Month 7]

   A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

2. Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies [At Month 7]

   Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

Secondary Outcome Measures

1. Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies [At Month 2 and Month 12]

   A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

2. GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies [At Month 2 and Month 12]

   Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

3. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Within 7 days (Day 0-6) after each dose and across doses]

   Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.

4. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within 7 days (Day 0-6) after each dose and across doses]

   Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

5. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Within 30 days (Day 0-29) after any vaccination]

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

6. Number of Subjects With NOCDs and Other MSCs [From Day 0 up to Month 7 and from Month 7 up to Month 12]

   New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

7. Number of Subjects With Serious Adverse Events (SAEs) [From Day 0 up to Month 7 and from Month 7 up to Month 12]

   SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.

8. Number of Subjects With Pregnancies and Their Outcomes [From Day 0 up to Month 12]

   Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.

9. Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed [At Month 7]

   Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

10. Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed [At Month 7]

    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

11. Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed [At Month 12]

    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

12. Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed [At Month 12]

    Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study.

• A female between, and including, 10 and 25 years of age at the time of the first vaccination.

• Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment. For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject's parent or legally acceptable representative. In addition, a written or oral, signed or thumb printed and witnessed informed assent must be obtained from the subject.

• Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study.

• Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0).

• Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit.

• Subjects must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.

• Subjects must have had no more than 6 sexual partners prior to enrolment.

• Subjects must be willing to undergo HIV voluntary counselling and testing and must be willing to be informed of their HIV status. Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.

• Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.

• Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after any dose of study vaccine.

• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.

• Previous administration of components of the investigational vaccine.

• Cancer or autoimmune disease under treatment.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection based on laboratory testing performed during the screening visit.

• Hypersensitivity to latex.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.

• Acute disease at the time of enrolment.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.

• History of any neurologic disorders or seizures.

• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

• Pregnant or breastfeeding female.

• A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Dakar		Senegal
2	GSK Investigational Site	Mwanza		Tanzania

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Kiviat N et al. Immunisation of African pre-teen/adolescent girls and young women with the HPV-16/18 AS04-adjuvanted vaccine. Abstract presented at South African Society of Obstetricians and Gynaecologists - O & G Update 2011. Pretoria, South Africa, 5-7 May 2011.
• Sow PS, Watson-Jones D, Kiviat N, Changalucha J, Mbaye KD, Brown J, Bousso K, Kavishe B, Andreasen A, Toure M, Kapiga S, Mayaud P, Hayes R, Lebacq M, Herazeh M, Thomas F, Descamps D. Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women. J Infect Dis. 2013 Jun 1;207(11):1753-63. doi: 10.1093/infdis/jis619. Epub 2012 Dec 13.
• Sow PS. et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in African preteen/adolescent girls and young women. Abstract presented at the African Organisation for Research and Training in Cancer (AORTIC). Cairo, Egypt, November 30 - December 3, 2011.
• Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjosé S. High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00481767
• Other Study ID Numbers: 106069; 2017-000416-42
• First Posted: Jun 4, 2007
• Last Update Posted: Nov 17, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Safety; Immunogenicity; Human Papillomavirus (HPV) vaccine
• Additional relevant MeSH terms: Vaccines

Study Results

Participant Flow

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Period Title: Overall Study
STARTED	450	226
COMPLETED	418	205
NOT COMPLETED	32	21

Baseline Characteristics

Arm/Group Title	Cervarix Group	Placebo Group	Total
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Total of all reporting groups
Overall Participants	450	226	676
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	16.9 (4.36)	16.8 (4.16)	16.9 (4.29)
Sex: Female, Male (Count of Participants)
Female	450 100%	226 100%	676 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African/African american	431 95.8%	219 96.9%	650 96.2%
Not specified	19 4.2%	7 3.1%	26 3.8%

Outcome Measures

1. Primary Outcome

Title	Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
Description	A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time Frame	At Month 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	212	98
10-14 years anti-HPV-16	130 28.9%	4 1.8%
15-25 years anti-HPV-16	190 42.2%	5 2.2%
10-14 years anti-HPV-18	128 28.4%	2 0.9%
15-25 years anti-HPV-18	212 47.1%	5 2.2%

2. Primary Outcome

Title	Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
Description	Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time Frame	At Month 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	237	114
10-14 years anti-HPV-16	18591.3	4.8
15-25 years anti-HPV-16	10664.0	5.3
10-14 years anti-HPV-18	6409.8	3.9
15-25 years anti-HPV-18	3653.6	4.6

3. Secondary Outcome

Title	Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
Description	A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time Frame	At Month 2 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	212	98
10-14 years anti-HPV-16 Month 2	130 28.9%	1 0.4%
15-25 years anti-HPV-16 Month 2	190 42.2%	3 1.3%
10-14 years anti-HPV-16 Month 12	128 28.4%	2 0.9%
15-25 years anti-HPV-16 Month 12	184 40.9%	7 3.1%
10-14 years anti-HPV-18 Month 2	128 28.4%	1 0.4%
15-25 years anti-HPV-18 Month 2	212 47.1%	4 1.8%
10-14 years anti-HPV-18 Month 12	125 27.8%	0 0%
15-25 years anti-HPV-18 Month 12	205 45.6%	6 2.7%

4. Secondary Outcome

Title	GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
Description	Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time Frame	At Month 2 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	237	112
10-14 years anti-HPV-16 Month 2	5340.2	4.5
15-25 years anti-HPV-16 Month 2	3732.6	4.9
10-14 years anti-HPV-16 Month 12	4016.2	4.7
15-25 years anti-HPV-16 Month 12	2464.2	5.6
10-14 years anti-HPV-18 Month 2	3016.7	3.9
15-25 years anti-HPV-18 Month 2	2039.3	4.6
10-14 years anti-HPV-18 Month 12	1422.1	3.7
15-25 years anti-HPV-18 Month 12	855.9	4.6

5. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.
Time Frame	Within 7 days (Day 0-6) after each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	450	226
Any Pain, Dose 1	309 68.7%	116 51.3%
Grade 3 Pain, Dose 1	2 0.4%	0 0%
Any Swelling, Dose 1	15 3.3%	7 3.1%
Grade 3 Swelling, Dose 1	0 0%	0 0%
Any Pain, Dose 2	265 58.9%	95 42%
Grade 3 Pain, Dose 2	0 0%	0 0%
Any Swelling, Dose 2	45 10%	15 6.6%
Grade 3 Swelling, Dose 2	0 0%	0 0%
Any Pain, Dose 3	200 44.4%	66 29.2%
Grade 3 Pain, Dose 3	0 0%	0 0%
Any Swelling, Dose 3	26 5.8%	10 4.4%
Grade 3 Swelling, Dose 3	0 0%	0 0%
Any Pain, Across doses	375 83.3%	166 73.5%
Grade 3 Pain, Across doses	2 0.4%	0 0%
Any Swelling, Across doses	74 16.4%	27 11.9%
Grade 3 Swelling, Across doses	0 0%	0 0%

6. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time Frame	Within 7 days (Day 0-6) after each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	450	226
Any Arthralgia, Dose 1	19 4.2%	10 4.4%
Grade 3 Arthralgia, Dose 1	0 0%	0 0%
Related Arthralgia, Dose 1	7 1.6%	2 0.9%
Any Fatigue, Dose 1	34 7.6%	12 5.3%
Grade 3 Fatigue, Dose 1	0 0%	0 0%
Related Fatigue, Dose 1	21 4.7%	3 1.3%
Any Fever, Dose 1	72 16%	43 19%
Grade 3 Fever, Dose 1	0 0%	0 0%
Related Fever, Dose 1	34 7.6%	17 7.5%
Any Gastrointestinal, Dose 1	34 7.6%	21 9.3%
Grade 3 Gastrointestinal, Dose 1	0 0%	0 0%
Related Gastrointestinal, Dose 1	14 3.1%	8 3.5%
Any Headache, Dose 1	89 19.8%	56 24.8%
Grade 3 Headache, Dose 1	0 0%	0 0%
Related Headache, Dose 1	51 11.3%	25 11.1%
Any Myalgia, Dose 1	35 7.8%	16 7.1%
Grade 3 Myalgia, Dose 1	0 0%	0 0%
Related Myalgia, Dose 1	22 4.9%	7 3.1%
Any Rash, Dose 1	14 3.1%	8 3.5%
Grade 3 Rash, Dose 1	0 0%	0 0%
Related Rash, Dose 1	1 0.2%	0 0%
Any Urticaria, Dose 1	12 2.7%	7 3.1%
Grade 3 Urticaria, Dose 1	0 0%	0 0%
Related Urticaria, Dose 1	0 0%	0 0%
Any Arthralgia, Dose 2	47 10.4%	17 7.5%
Grade 3 Arthralgia, Dose 2	0 0%	0 0%
Related Arthralgia, Dose 2	4 0.9%	2 0.9%
Any Fatigue, Dose 2	62 13.8%	25 11.1%
Grade 3 Fatigue, Dose 2	0 0%	0 0%
Related Fatigue, Dose 2	17 3.8%	4 1.8%
Any Fever, Dose 2	82 18.2%	33 14.6%
Grade 3 Fever, Dose 2	0 0%	0 0%
Related Fever, Dose 2	19 4.2%	8 3.5%
Any Gastrointestinal, Dose 2	66 14.7%	26 11.5%
Grade 3 Gastrointestinal, Dose 2	0 0%	0 0%
Related Gastrointestinal, Dose 2	15 3.3%	6 2.7%
Any Headache, Dose 2	96 21.3%	49 21.7%
Grade 3 Headache, Dose 2	0 0%	0 0%
Related Headache, Dose 2	40 8.9%	18 8%
Any Myalgia, Dose 2	50 11.1%	17 7.5%
Grade 3 Myalgia, Dose 2	0 0%	0 0%
Related Myalgia, Dose 2	9 2%	3 1.3%
Any Rash, Dose 2	44 9.8%	15 6.6%
Grade 3 Rash, Dose 2	0 0%	0 0%
Related Rash, Dose 2	1 0.2%	0 0%
Any Urticaria, Dose 2	43 9.6%	14 6.2%
Grade 3 Urticaria, Dose 2	0 0%	0 0%
Related Urticaria, Dose 2	0 0%	0 0%
Any Arthralgia, Dose 3	28 6.2%	10 4.4%
Grade 3 Arthralgia, Dose 3	0 0%	0 0%
Related Arthralgia, Dose 3	0 0%	0 0%
Any Fatigue, Dose 3	34 7.6%	13 5.8%
Grade 3 Fatigue, Dose 3	0 0%	0 0%
Related Fatigue, Dose 3	4 0.9%	3 1.3%
Any Fever, Dose 3	81 18%	33 14.6%
Grade 3 Fever, Dose 3	0 0%	0 0%
Related Fever, Dose 3	20 4.4%	9 4%
Any Gastrointestinal, Dose 3	43 9.6%	19 8.4%
Grade 3 Gastrointestinal, Dose 3	0 0%	0 0%
Related Gastrointestinal, Dose 3	5 1.1%	5 2.2%
Any Headache, Dose 3	71 15.8%	33 14.6%
Grade 3 Headache, Dose 3	0 0%	0 0%
Related Headache, Dose 3	22 4.9%	12 5.3%
Any Myalgia, Dose 3	28 6.2%	10 4.4%
Grade 3 Myalgia, Dose 3	0 0%	0 0%
Related Myalgia, Dose 3	1 0.2%	0 0%
Any Rash, Dose 3	26 5.8%	12 5.3%
Grade 3 Rash, Dose 3	0 0%	0 0%
Related Rash, Dose 3	0 0%	0 0%
Any Urticaria, Dose 3	26 5.8%	11 4.9%
Grade 3 Urticaria, Dose 3	0 0%	0 0%
Related Urticaria, Dose 3	0 0%	0 0%
Any Arthralgia, Across doses	77 17.1%	32 14.2%
Grade 3 Arthralgia, Across doses	0 0%	0 0%
Related Arthralgia, Across doses	10 2.2%	4 1.8%
Any Fatigue, Across doses	111 24.7%	42 18.6%
Grade 3 Fatigue, Across doses	0 0%	0 0%
Related Fatigue, Across doses	39 8.7%	9 4%
Any Fever, Across doses	147 32.7%	70 31%
Grade 3 Fever, Across doses	0 0%	0 0%
Related Fever, Across doses	57 12.7%	27 11.9%
Any Gastrointestinal, Across doses	118 26.2%	56 24.8%
Grade 3 Gastrointestinal, Across doses	0 0%	0 0%
Related Gastrointestinal, Across doses	31 6.9%	17 7.5%
Any Headache, Across doses	189 42%	109 48.2%
Grade 3 Headache, Across doses	0 0%	0 0%
Related Headache, Across doses	101 22.4%	46 20.4%
Any Myalgia, Across doses	90 20%	36 15.9%
Grade 3 Myalgia, Across doses	0 0%	0 0%
Related Myalgia, Across doses	27 6%	9 4%
Any Rash, Across doses	71 15.8%	30 13.3%
Grade 3 Rash, Across doses	0 0%	0 0%
Related Rash, Across doses	2 0.4%	0 0%
Any Urticaria, Across doses	68 15.1%	27 11.9%
Grade 3 Urticaria, Across doses	0 0%	0 0%
Related Urticaria, Across doses	0 0%	0 0%

7. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Time Frame	Within 30 days (Day 0-29) after any vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	450	226
Any AE(s)	235 52.2%	142 62.8%
Grade 3 AE(s)	5 1.1%	1 0.4%
Related AE(s)	3 0.7%	4 1.8%

8. Secondary Outcome

Title	Number of Subjects With NOCDs and Other MSCs
Description	New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame	From Day 0 up to Month 7 and from Month 7 up to Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	450	226
NOCD(s) up to Month 7	10 2.2%	8 3.5%
NOCD(s) Month 7-12	1 0.2%	3 1.3%
MSC(s) up to Month 7	289 64.2%	161 71.2%
MSC(s) Month 7-12	121 26.9%	68 30.1%

9. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	From Day 0 up to Month 7 and from Month 7 up to Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	450	226
up to Month 7	12 2.7%	10 4.4%
up to Month 12	17 3.8%	14 6.2%

10. Secondary Outcome

Title	Number of Subjects With Pregnancies and Their Outcomes
Description	Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.
Time Frame	From Day 0 up to Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented and who reported pregnancies (and their outcomes).

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	14	10
Ectopic pregnancy	1 0.2%	0 0%
Elective termination	3 0.7%	3 1.3%
Live infant	5 1.1%	5 2.2%
Premature live infant	3 0.7%	1 0.4%
Lost to follow-up	1 0.2%	0 0%
Spontaneous abortion	1 0.2%	1 0.4%

11. Secondary Outcome

Title	Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Description	Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time Frame	At Month 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	217	105
ALT, pre-vacc. ABOVE, Month 7 NORMAL	7 1.6%	4 1.8%
ALT, pre-vacc.ABOVE, Month 7 BELOW	0 0%	0 0%
ALT, pre-vacc. ABOVE, Month 7 ABOVE	1 0.2%	0 0%
ALT, pre-vacc. BELOW, Month 7 NORMAL	15 3.3%	7 3.1%
ALT, pre-vacc. BELOW, Month 7 BELOW	24 5.3%	10 4.4%
ALT, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
ALT, pre-vacc. NORMAL, Month 7 NORMAL	137 30.4%	57 25.2%
ALT, pre-vacc. NORMAL, Month 7 BELOW	30 6.7%	25 11.1%
ALT, pre-vacc. NORMAL, Month 7 ABOVE	3 0.7%	2 0.9%
BAS, pre-vacc. NORMAL, Month 7 NORMAL	216 48%	105 46.5%
BAS, pre-vacc. NORMAL, Month 7 BELOW	0 0%	0 0%
BAS, pre-vacc. NORMAL, Month 7 ABOVE	1 0.2%	0 0%
CREA, pre-vacc. ABOVE, Month 7 NORMAL	1 0.2%	1 0.4%
CREA, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
CREA, pre-vacc. ABOVE, Month 7 ABOVE	1 0.2%	0 0%
CREA, pre-vacc. BELOW, Month 7 NORMAL	19 4.2%	13 5.8%
CREA, pre-vacc. BELOW, Month 7 BELOW	37 8.2%	17 7.5%
CREA, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
CREA, pre-vacc. NORMAL, Month 7 NORMAL	149 33.1%	68 30.1%
CREA, pre-vacc. NORMAL, Month 7 BELOW	10 2.2%	4 1.8%
CREA, pre-vacc. NORMAL, Month 7 ABOVE	0 0%	2 0.9%
EOS, pre-vacc. ABOVE, Month 7 NORMAL	9 2%	12 5.3%
EOS, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
EOS, pre-vacc. ABOVE, Month 7 ABOVE	34 7.6%	16 7.1%
EOS, pre-vacc. BELOW, Month 7 NORMAL	17 3.8%	9 4%
EOS, pre-vacc. BELOW, Month 7 BELOW	2 0.4%	1 0.4%
EOS, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
EOS, pre-vacc. NORMAL, Month 7 NORMAL	134 29.8%	56 24.8%
EOS, pre-vacc. NORMAL, Month 7 BELOW	3 0.7%	2 0.9%
EOS, pre-vacc. NORMAL, Month 7 ABOVE	18 4%	9 4%
HC, pre-vacc. BELOW, Month 7 NORMAL	16 3.6%	7 3.1%
HC, pre-vacc. BELOW, Month 7 BELOW	59 13.1%	26 11.5%
HC, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
HC, pre-vacc. NORMAL, Month 7 NORMAL	104 23.1%	52 23%
HC, pre-vacc. NORMAL, Month 7 BELOW	38 8.4%	20 8.8%
HC, pre-vacc. NORMAL, Month 7 ABOVE	0 0%	0 0%
LYM, pre-vacc. ABOVE, Month 7 NORMAL	23 5.1%	11 4.9%
LYM, pre-vacc. ABOVE, Month 7 BELOW	4 0.9%	3 1.3%
LYM, pre-vacc. ABOVE, Month 7 ABOVE	50 11.1%	27 11.9%
LYM, pre-vacc. BELOW, Month 7 NORMAL	23 5.1%	8 3.5%
LYM, pre-vacc. BELOW, Month 7 BELOW	11 2.4%	6 2.7%
LYM, pre-vacc. BELOW, Month 7 ABOVE	7 1.6%	5 2.2%
LYM, pre-vacc. NORMAL, Month 7 NORMAL	47 10.4%	19 8.4%
LYM, pre-vacc. NORMAL, Month 7 BELOW	17 3.8%	2 0.9%
LYM, pre-vacc. NORMAL, Month 7 ABOVE	35 7.8%	24 10.6%
MON, pre-vacc. ABOVE, Month 7 NORMAL	17 3.8%	4 1.8%
MON, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
MON, pre-vacc. ABOVE, Month 7 ABOVE	31 6.9%	31 13.7%
MON, pre-vacc. NORMAL, Month 7 NORMAL	108 24%	45 19.9%
MON, pre-vacc. NORMAL, Month 7 BELOW	0 0%	0 0%
MON, pre-vacc. NORMAL, Month 7 ABOVE	61 13.6%	25 11.1%
NEU, pre-vacc. ABOVE, Month 7 NORMAL	0 0%	0 0%
NEU, pre-vacc. ABOVE, Month 7 BELOW	7 1.6%	3 1.3%
NEU, pre-vacc. ABOVE, Month 7 ABOVE	1 0.2%	0 0%
NEU, pre-vacc. BELOW, Month 7 NORMAL	9 2%	4 1.8%
NEU, pre-vacc. BELOW, Month 7 BELOW	165 36.7%	86 38.1%
NEU, pre-vacc. BELOW, Month 7 ABOVE	2 0.4%	1 0.4%
NEU, pre-vacc. NORMAL, Month 7 NORMAL	4 0.9%	1 0.4%
NEU, pre-vacc. NORMAL, Month 7 BELOW	26 5.8%	10 4.4%
NEU, pre-vacc. NORMAL, Month 7 ABOVE	3 0.7%	0 0%
PLA, pre-vacc. ABOVE, Month 7 NORMAL	10 2.2%	4 1.8%
PLA, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
PLA, pre-vacc. ABOVE, Month 7 ABOVE	7 1.6%	2 0.9%
PLA. pre-vacc. BELOW, Month 7 NORMAL	1 0.2%	0 0%
PLA. pre-vacc. BELOW, Month 7 BELOW	1 0.2%	2 0.9%
PLA. pre-vacc. BELOW, Month 7 ABOVE	0 0%	1 0.4%
PLA, pre-vacc. NORMAL, Month 7 NORMAL	194 43.1%	96 42.5%
PLA, pre-vacc. NORMAL, Month 7 BELOW	0 0%	0 0%
PLA, pre-vacc. NORMAL, Month 7 ABOVE	4 0.9%	0 0%
RBC, pre-vacc. BELOW, Month 7 NORMAL	10 2.2%	3 1.3%
RBC, pre-vacc. BELOW, Month 7 BELOW	19 4.2%	8 3.5%
RBC, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
RBC, pre-vacc. NORMAL, Month 7 NORMAL	176 39.1%	89 39.4%
RBC, pre-vacc. NORMAL, Month 7 BELOW	12 2.7%	5 2.2%
RBC, pre-vacc. NORMAL, Month 7 ABOVE	0 0%	0 0%
WBC, pre-vacc. ABOVE, Month 7 NORMAL	6 1.3%	6 2.7%
WBC, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
WBC, pre-vacc. ABOVE, Month 7 ABOVE	3 0.7%	1 0.4%
WBC, pre-vacc. BELOW, Month 7 NORMAL	5 1.1%	6 2.7%
WBC, pre-vacc. BELOW, Month 7 BELOW	16 3.6%	6 2.7%
WBC, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
WBC, pre-vacc. NORMAL, Month 7 NORMAL	158 35.1%	72 31.9%
WBC, pre-vacc. NORMAL, Month 7 BELOW	26 5.8%	13 5.8%
WBC, pre-vacc. NORMAL, Month 7 ABOVE	3 0.7%	1 0.4%

12. Secondary Outcome

Title	Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Description	Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time Frame	At Month 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	187	96
ALT, pre-vacc. ABOVE, Month 7 NORMAL	2 0.4%	2 0.9%
ALT, pre-vacc. ABOVE, Month 7 BELOW	0 0%	1 0.4%
ALT, pre-vacc. ABOVE, Month 7 ABOVE	1 0.2%	0 0%
ALT, pre-vacc. BELOW, Month 7 NORMAL	7 1.6%	3 1.3%
ALT, pre-vacc. BELOW, Month 7 BELOW	6 1.3%	8 3.5%
ALT, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
ALT, pre-vacc. NORMAL, Month 7 NORMAL	144 32%	65 28.8%
ALT, pre-vacc. NORMAL, Month 7 BELOW	39 8.7%	20 8.8%
ALT, pre-vacc. NORMAL, Month 7 ABOVE	0 0%	0 0%
BAS, pre-vacc. ABOVE, Month 7 NORMAL	19 4.2%	12 5.3%
BAS, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
BAS, pre-vacc. ABOVE, Month 7 ABOVE	2 0.4%	0 0%
BAS, pre-vacc. NORMAL, Month 7 NORMAL	163 36.2%	81 35.8%
BAS, pre-vacc. NORMAL, Month 7 BELOW	0 0%	0 0%
BAS, pre-vacc. NORMAL, Month 7 ABOVE	15 3.3%	6 2.7%
CREA, pre-vacc. BELOW, Month 7 NORMAL	2 0.4%	2 0.9%
CREA, pre-vacc. BELOW, Month 7 BELOW	41 9.1%	12 5.3%
CREA, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
CREA, pre-vacc. NORMAL, Month 7 NORMAL	40 8.9%	14 6.2%
CREA, pre-vacc. NORMAL, Month 7 BELOW	116 25.8%	71 31.4%
CREA, pre-vacc. NORMAL, Month 7 ABOVE	0 0%	0 0%
EOS, pre-vacc. ABOVE, Month 7 NORMAL	14 3.1%	4 1.8%
EOS, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
EOS, pre-vacc. ABOVE, Month 7 ABOVE	61 13.6%	35 15.5%
EOS, pre-vacc. ABOVE, Month 7 MISSING	1 0.2%	0 0%
EOS, pre-vacc. NORMAL, Month 7 NORMAL	92 20.4%	52 23%
EOS, pre-vacc. NORMAL, Month 7 BELOW	0 0%	0 0%
EOS, pre-vacc. NORMAL, Month 7 ABOVE	31 6.9%	8 3.5%
HC, pre-vacc. ABOVE, Month 7 NORMAL	1 0.2%	0 0%
HC, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
HC, pre-vacc. ABOVE, Month 7 ABOVE	0 0%	0 0%
HC, pre-vacc. BELOW, Month 7 NORMAL	20 4.4%	6 2.7%
HC, pre-vacc. BELOW, Month 7 BELOW	40 8.9%	29 12.8%
HC, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
HC, pre-vacc. NORMAL, Month 7 NORMAL	118 26.2%	51 22.6%
HC, pre-vacc. NORMAL, Month 7 BELOW	20 4.4%	13 5.8%
HC, pre-vacc. NORMAL, Month 7 ABOVE	0 0%	0 0%
LYM, pre-vacc. ABOVE, Month 7 NORMAL	12 2.7%	7 3.1%
LYM, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
LYM, pre-vacc. ABOVE, Month 7 ABOVE	8 1.8%	1 0.4%
LYM, pre-vacc. NORMAL, Month 7 NORMAL	166 36.9%	81 35.8%
LYM, pre-vacc. NORMAL, Month 7 BELOW	3 0.7%	0 0%
LYM, pre-vacc. NORMAL, Month 7 ABOVE	10 2.2%	10 4.4%
MON, pre-vacc. ABOVE, Month 7 NORMAL	6 1.3%	6 2.7%
MON, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
MON, pre-vacc. ABOVE, Month 7 ABOVE	6 1.3%	1 0.4%
MON, pre-vacc. NORMAL, Month 7 NORMAL	180 40%	85 37.6%
MON, pre-vacc. NORMAL, Month 7 BELOW	0 0%	0 0%
MON, pre-vacc. NORMAL, Month 7 ABOVE	7 1.6%	7 3.1%
NEU, pre-vacc. BELOW, Month 7 NORMAL	13 2.9%	9 4%
NEU, pre-vacc. BELOW, Month 7 BELOW	22 4.9%	7 3.1%
NEU, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
NEU, pre-vacc. BELOW, Month 7 MISSING	1 0.2%	0 0%
NEU, pre-vacc. NORMAL, Month 7 NORMAL	145 32.2%	70 31%
NEU, pre-vacc. NORMAL, Month 7 BELOW	17 3.8%	13 5.8%
NEU, pre-vacc. NORMAL, Month 7 ABOVE	1 0.2%	0 0%
PLA, pre-vacc. ABOVE, Month 7 NORMAL	7 1.6%	1 0.4%
PLA, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
PLA, pre-vacc. ABOVE, Month 7 ABOVE	3 0.7%	2 0.9%
PLA, pre-vacc. BELOW, Month 7 NORMAL	4 0.9%	0 0%
PLA, pre-vacc. BELOW, Month 7 BELOW	1 0.2%	0 0%
PLA, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
PLA, pre-vacc. NORMAL, Month 7 NORMAL	180 40%	92 40.7%
PLA, pre-vacc. NORMAL, Month 7 BELOW	2 0.4%	0 0%
PLA, pre-vacc. NORMAL, Month 7 ABOVE	2 0.4%	4 1.8%
RBC, pre-vacc. ABOVE, Month 7 NORMAL	6 1.3%	4 1.8%
RBC, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
RBC, pre-vacc. ABOVE, Month 7 ABOVE	5 1.1%	3 1.3%
RBC, pre-vacc. BELOW, Month 7 NORMAL	1 0.2%	0 0%
RBC, pre-vacc. BELOW, Month 7 BELOW	1 0.2%	1 0.4%
RBC, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
RBC, pre-vacc. NORMAL, Month 7 NORMAL	177 39.3%	90 39.8%
RBC, pre-vacc. NORMAL, Month 7 BELOW	5 1.1%	0 0%
RBC, pre-vacc. NORMAL, Month 7 ABOVE	4 0.9%	1 0.4%
WBC, pre-vacc. ABOVE, Month 7 NORMAL	13 2.9%	6 2.7%
WBC, pre-vacc. ABOVE, Month 7 BELOW	0 0%	0 0%
WBC, pre-vacc. ABOVE, Month 7 ABOVE	4 0.9%	1 0.4%
WBC, pre-vacc. BELOW, Month 7 NORMAL	0 0%	2 0.9%
WBC, pre-vacc. BELOW, Month 7 BELOW	0 0%	0 0%
WBC, pre-vacc. BELOW, Month 7 ABOVE	0 0%	0 0%
WBC, pre-vacc. NORMAL, Month 7 NORMAL	177 39.3%	86 38.1%
WBC, pre-vacc. NORMAL, Month 7 BELOW	4 0.9%	2 0.9%
WBC, pre-vacc. NORMAL, Month 7 ABOVE	1 0.2%	2 0.9%

13. Secondary Outcome

Title	Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Description	Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	211	102
ALT, pre-vacc. ABOVE, Month 12 NORMAL	8 1.8%	4 1.8%
ALT, pre-vacc.ABOVE, Month 12 BELOW	0 0%	0 0%
ALT, pre-vacc. ABOVE, Month 12 ABOVE	0 0%	0 0%
ALT, pre-vacc. BELOW, Month 12 NORMAL	17 3.8%	9 4%
ALT, pre-vacc. BELOW, Month 12 BELOW	21 4.7%	8 3.5%
ALT, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
ALT, pre-vacc. NORMAL, Month 12 NORMAL	139 30.9%	61 27%
ALT, pre-vacc. NORMAL, Month 12 BELOW	24 5.3%	17 7.5%
ALT, pre-vacc. NORMAL, Month 12 ABOVE	2 0.4%	3 1.3%
BAS, pre-vacc. NORMAL, Month 12 NORMAL	210 46.7%	102 45.1%
BAS, pre-vacc. NORMAL, Month 12 BELOW	0 0%	0 0%
BAS, pre-vacc. NORMAL, Month 12 ABOVE	1 0.2%	0 0%
CREA, pre-vacc. ABOVE, Month 12 NORMAL	1 0.2%	0 0%
CREA, pre-vacc. ABOVE, Month 12 BELOW	0 0%	1 0.4%
CREA, pre-vacc. ABOVE, Month 12 ABOVE	1 0.2%	0 0%
CREA, pre-vacc. BELOW, Month 12 NORMAL	13 2.9%	6 2.7%
CREA, pre-vacc. BELOW, Month 12 BELOW	43 9.6%	23 10.2%
CREA, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
CREA, pre-vacc. NORMAL, Month 12 NORMAL	130 28.9%	64 28.3%
CREA, pre-vacc. NORMAL, Month 12 BELOW	23 5.1%	8 3.5%
CREA, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	0 0%
EOS, pre-vacc. ABOVE, Month 12 NORMAL	14 3.1%	11 4.9%
EOS, pre-vacc. ABOVE, Month 12 BELOW	1 0.2%	0 0%
EOS, pre-vacc. ABOVE, Month 12 ABOVE	28 6.2%	17 7.5%
EOS, pre-vacc. BELOW, Month 12 NORMAL	13 2.9%	6 2.7%
EOS, pre-vacc. BELOW, Month 12 BELOW	6 1.3%	3 1.3%
EOS, pre-vacc. BELOW, Month 12 ABOVE	0 0%	1 0.4%
EOS, pre-vacc. NORMAL, Month 12 NORMAL	126 28%	52 23%
EOS, pre-vacc. NORMAL, Month 12 BELOW	6 1.3%	2 0.9%
EOS, pre-vacc. NORMAL, Month 12 ABOVE	17 3.8%	10 4.4%
HC, pre-vacc. BELOW, Month 12 NORMAL	15 3.3%	10 4.4%
HC, pre-vacc. BELOW, Month 12 BELOW	56 12.4%	23 10.2%
HC, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
HC, pre-vacc. NORMAL, Month 12 NORMAL	108 24%	45 19.9%
HC, pre-vacc. NORMAL, Month 12 BELOW	32 7.1%	24 10.6%
HC, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	0 0%
LYM, pre-vacc. ABOVE, Month 12 NORMAL	24 5.3%	16 7.1%
LYM, pre-vacc. ABOVE, Month 12 BELOW	4 0.9%	3 1.3%
LYM, pre-vacc. ABOVE, Month 12 ABOVE	47 10.4%	22 9.7%
LYM, pre-vacc. BELOW, Month 12 NORMAL	9 2%	8 3.5%
LYM, pre-vacc. BELOW, Month 12 BELOW	15 3.3%	5 2.2%
LYM, pre-vacc. BELOW, Month 12 ABOVE	14 3.1%	6 2.7%
LYM, pre-vacc. NORMAL, Month 12 NORMAL	48 10.7%	24 10.6%
LYM, pre-vacc. NORMAL, Month 12 BELOW	27 6%	4 1.8%
LYM, pre-vacc. NORMAL, Month 12 ABOVE	23 5.1%	14 6.2%
MON, pre-vacc. ABOVE, Month 12 NORMAL	13 2.9%	10 4.4%
MON, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
MON, pre-vacc. ABOVE, Month 12 ABOVE	32 7.1%	24 10.6%
MON, pre-vacc. NORMAL, Month 12 NORMAL	102 22.7%	38 16.8%
MON, pre-vacc. NORMAL, Month 12 BELOW	0 0%	0 0%
MON, pre-vacc. NORMAL, Month 12 ABOVE	64 14.2%	30 13.3%
NEU, pre-vacc. ABOVE, Month 12 NORMAL	4 0.9%	0 0%
NEU, pre-vacc. ABOVE, Month 12 BELOW	4 0.9%	3 1.3%
NEU, pre-vacc. ABOVE, Month 12 ABOVE	0 0%	0 0%
NEU, pre-vacc. BELOW, Month 12 NORMAL	11 2.4%	5 2.2%
NEU, pre-vacc. BELOW, Month 12 BELOW	160 35.6%	83 36.7%
NEU, pre-vacc. BELOW, Month 12 ABOVE	2 0.4%	0 0%
NEU, pre-vacc. NORMAL, Month 12 NORMAL	7 1.6%	1 0.4%
NEU, pre-vacc. NORMAL, Month 12 BELOW	22 4.9%	9 4%
NEU, pre-vacc. NORMAL, Month 12 ABOVE	1 0.2%	1 0.4%
PLA, pre-vacc. ABOVE, Month 12 NORMAL	13 2.9%	4 1.8%
PLA, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
PLA, pre-vacc. ABOVE, Month 12 ABOVE	4 0.9%	2 0.9%
PLA. pre-vacc. BELOW, Month 12 NORMAL	1 0.2%	1 0.4%
PLA. pre-vacc. BELOW, Month 12 BELOW	1 0.2%	2 0.9%
PLA. pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
PLA, pre-vacc. NORMAL, Month 12 NORMAL	188 41.8%	93 41.2%
PLA, pre-vacc. NORMAL, Month 12 BELOW	3 0.7%	0 0%
PLA, pre-vacc. NORMAL, Month 12 ABOVE	1 0.2%	0 0%
RBC, pre-vacc. BELOW, Month 12 NORMAL	8 1.8%	5 2.2%
RBC, pre-vacc. BELOW, Month 12 BELOW	19 4.2%	6 2.7%
RBC, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
RBC, pre-vacc. NORMAL, Month 12 NORMAL	169 37.6%	80 35.4%
RBC, pre-vacc. NORMAL, Month 12 BELOW	15 3.3%	11 4.9%
RBC, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	0 0%
WBC, pre-vacc. ABOVE, Month 12 NORMAL	6 1.3%	7 3.1%
WBC, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
WBC, pre-vacc. ABOVE, Month 12 ABOVE	2 0.4%	0 0%
WBC, pre-vacc. BELOW, Month 12 NORMAL	10 2.2%	5 2.2%
WBC, pre-vacc. BELOW, Month 12 BELOW	9 2%	7 3.1%
WBC, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
WBC, pre-vacc. NORMAL, Month 12 NORMAL	156 34.7%	64 28.3%
WBC, pre-vacc. NORMAL, Month 12 BELOW	22 4.9%	16 7.1%
WBC, pre-vacc. NORMAL, Month 12 ABOVE	6 1.3%	3 1.3%

14. Secondary Outcome

Title	Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Description	Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.

Arm/Group Title	Cervarix Group	Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.	Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Measure Participants	194	100
ALT, pre-vacc. ABOVE, Month 12 NORMAL	2 0.4%	2 0.9%
ALT, pre-vacc. ABOVE, Month 12 BELOW	0 0%	1 0.4%
ALT, pre-vacc. ABOVE, Month 12 ABOVE	1 0.2%	1 0.4%
ALT, pre-vacc. BELOW, Month 12 NORMAL	12 2.7%	8 3.5%
ALT, pre-vacc. BELOW, Month 12 BELOW	1 0.2%	3 1.3%
ALT, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
ALT, pre-vacc. NORMAL, Month 12 NORMAL	166 36.9%	73 32.3%
ALT, pre-vacc. NORMAL, Month 12 BELOW	24 5.3%	13 5.8%
ALT, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	1 0.4%
BAS, pre-vacc. ABOVE, Month 12 NORMAL	21 4.7%	12 5.3%
BAS, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
BAS, pre-vacc. ABOVE, Month 12 ABOVE	2 0.4%	1 0.4%
BAS, pre-vacc. NORMAL, Month 12 NORMAL	174 38.7%	81 35.8%
BAS, pre-vacc. NORMAL, Month 12 BELOW	0 0%	0 0%
BAS, pre-vacc. NORMAL, Month 12 ABOVE	9 2%	8 3.5%
CREA, pre-vacc. BELOW, Month 12 NORMAL	2 0.4%	0 0%
CREA, pre-vacc. BELOW, Month 12 BELOW	40 8.9%	14 6.2%
CREA, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
CREA, pre-vacc. NORMAL, Month 12 NORMAL	48 10.7%	19 8.4%
CREA, pre-vacc. NORMAL, Month 12 BELOW	116 25.8%	69 30.5%
CREA, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	0 0%
EOS, pre-vacc. ABOVE, Month 12 NORMAL	22 4.9%	10 4.4%
EOS, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
EOS, pre-vacc. ABOVE, Month 12 ABOVE	57 12.7%	33 14.6%
EOS, pre-vacc. NORMAL, Month 12 NORMAL	93 20.7%	48 21.2%
EOS, pre-vacc. NORMAL, Month 12 BELOW	0 0%	0 0%
EOS, pre-vacc. NORMAL, Month 12 ABOVE	34 7.6%	11 4.9%
HC, pre-vacc. BELOW, Month 12 NORMAL	29 6.4%	10 4.4%
HC, pre-vacc. BELOW, Month 12 BELOW	34 7.6%	28 12.4%
HC, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
HC, pre-vacc. NORMAL, Month 12 NORMAL	107 23.8%	48 21.2%
HC, pre-vacc. NORMAL, Month 12 BELOW	36 8%	16 7.1%
HC, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	0 0%
LYM, pre-vacc. ABOVE, Month 12 NORMAL	9 2%	3 1.3%
LYM, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
LYM, pre-vacc. ABOVE, Month 12 ABOVE	9 2%	5 2.2%
LYM, pre-vacc. NORMAL, Month 12 NORMAL	168 37.3%	81 35.8%
LYM, pre-vacc. NORMAL, Month 12 BELOW	0 0%	2 0.9%
LYM, pre-vacc. NORMAL, Month 12 ABOVE	20 4.4%	11 4.9%
MON, pre-vacc. ABOVE, Month 12 NORMAL	8 1.8%	6 2.7%
MON, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
MON, pre-vacc. ABOVE, Month 12 ABOVE	4 0.9%	1 0.4%
MON, pre-vacc. NORMAL, Month 12 NORMAL	184 40.9%	88 38.9%
MON, pre-vacc. NORMAL, Month 12 BELOW	0 0%	0 0%
MON, pre-vacc. NORMAL, Month 12 ABOVE	10 2.2%	7 3.1%
NEU, pre-vacc. BELOW, Month 12 NORMAL	18 4%	6 2.7%
NEU, pre-vacc. BELOW, Month 12 BELOW	18 4%	11 4.9%
NEU, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
NEU, pre-vacc. NORMAL, Month 12 NORMAL	138 30.7%	72 31.9%
NEU, pre-vacc. NORMAL, Month 12 BELOW	32 7.1%	13 5.8%
NEU, pre-vacc. NORMAL, Month 12 ABOVE	0 0%	0 0%
PLA, pre-vacc. ABOVE, Month 12 NORMAL	8 1.8%	1 0.4%
PLA, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
PLA, pre-vacc. ABOVE, Month 12 ABOVE	2 0.4%	1 0.4%
PLA, pre-vacc. BELOW, Month 12 NORMAL	5 1.1%	0 0%
PLA, pre-vacc. BELOW, Month 12 BELOW	0 0%	0 0%
PLA, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
PLA, pre-vacc. NORMAL, Month 12 NORMAL	185 41.1%	96 42.5%
PLA, pre-vacc. NORMAL, Month 12 BELOW	1 0.2%	2 0.9%
PLA, pre-vacc. NORMAL, Month 12 ABOVE	5 1.1%	2 0.9%
RBC, pre-vacc. ABOVE, Month 12 NORMAL	5 1.1%	3 1.3%
RBC, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
RBC, pre-vacc. ABOVE, Month 12 ABOVE	5 1.1%	4 1.8%
RBC, pre-vacc. BELOW, Month 12 NORMAL	2 0.4%	0 0%
RBC, pre-vacc. BELOW, Month 12 BELOW	1 0.2%	2 0.9%
RBC, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
RBC, pre-vacc. NORMAL, Month 12 NORMAL	182 40.4%	91 40.3%
RBC, pre-vacc. NORMAL, Month 12 BELOW	6 1.3%	2 0.9%
RBC, pre-vacc. NORMAL, Month 12 ABOVE	5 1.1%	0 0%
WBC, pre-vacc. ABOVE, Month 12 NORMAL	12 2.7%	5 2.2%
WBC, pre-vacc. ABOVE, Month 12 BELOW	0 0%	0 0%
WBC, pre-vacc. ABOVE, Month 12 ABOVE	5 1.1%	1 0.4%
WBC, pre-vacc. BELOW, Month 12 NORMAL	0 0%	2 0.9%
WBC, pre-vacc. BELOW, Month 12 BELOW	0 0%	0 0%
WBC, pre-vacc. BELOW, Month 12 ABOVE	0 0%	0 0%
WBC, pre-vacc. NORMAL, Month 12 NORMAL	165 36.7%	85 37.6%
WBC, pre-vacc. NORMAL, Month 12 BELOW	14 3.1%	5 2.2%
WBC, pre-vacc. NORMAL, Month 12 ABOVE	10 2.2%	4 1.8%

Adverse Events

Time Frame	Solicited local and general symptoms: within 7 days (Day 0-6) after vaccination; Unsolicited AEs: within 30 days (Day 0-29) after any vaccination; SAEs: during the whole study period (from Day 0 up to Month 12).
Arm/Group Title	Cervarix Group		Placebo Group
Arm/Group Description	Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.		Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
All Cause Mortality
	Cervarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/450 (0%)		0/226 (0%)
Serious Adverse Events
	Cervarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/450 (3.8%)		14/226 (6.2%)
Endocrine disorders
Goitre	1/450 (0.2%)		0/226 (0%)
Gastrointestinal disorders
Abdominal pain lower	1/450 (0.2%)		0/226 (0%)
Haemorrhoids	1/450 (0.2%)		0/226 (0%)
Infections and infestations
Malaria	10/450 (2.2%)		11/226 (4.9%)
Urinary tract infection	0/450 (0%)		3/226 (1.3%)
Pneumonia bacterial	1/450 (0.2%)		1/226 (0.4%)
Amoebiasis	1/450 (0.2%)		0/226 (0%)
Appendicitis	1/450 (0.2%)		0/226 (0%)
Burn infection	0/450 (0%)		1/226 (0.4%)
Dysentery	1/450 (0.2%)		0/226 (0%)
Gastroenteritis	1/450 (0.2%)		0/226 (0%)
Pelvic inflammatory disease	1/450 (0.2%)		0/226 (0%)
Pyomyositis	1/450 (0.2%)		0/226 (0%)
Tonsillitis bacterial	1/450 (0.2%)		0/226 (0%)
Tonsillitis	0/450 (0%)		1/226 (0.4%)
Injury, poisoning and procedural complications
Femur fracture	1/450 (0.2%)		0/226 (0%)
Nervous system disorders
Neuropathy vitamin b6 deficiency	1/450 (0.2%)		0/226 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete	1/450 (0.2%)		1/226 (0.4%)
Ectopic pregnancy	1/450 (0.2%)		0/226 (0%)
Postpartum haemorrhage	1/450 (0.2%)		0/226 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	1/450 (0.2%)		0/226 (0%)
Other (Not Including Serious) Adverse Events
	Cervarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	433/450 (96.2%)		216/226 (95.6%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/450 (0.2%)	1	0/226 (0%)	0
Lymphadenitis	1/450 (0.2%)	1	0/226 (0%)	0
Cardiac disorders
Palpitations	1/450 (0.2%)	1	0/226 (0%)	0
Ear and labyrinth disorders
Ear pain	5/450 (1.1%)	5	2/226 (0.9%)	2
Vertigo	13/450 (2.9%)	15	3/226 (1.3%)	4
Eye disorders
Conjunctivitis	8/450 (1.8%)	8	1/226 (0.4%)	1
Conjunctivitis allergic	0/450 (0%)	0	1/226 (0.4%)	1
Eye allergy	0/450 (0%)	0	1/226 (0.4%)	1
Eye irritation	0/450 (0%)	0	1/226 (0.4%)	1
Eye pain	4/450 (0.9%)	4	0/226 (0%)	0
Eye pruritus	2/450 (0.4%)	2	0/226 (0%)	0
Eyelid oedema	1/450 (0.2%)	1	1/226 (0.4%)	1
Lacrimation increased	1/450 (0.2%)	1	1/226 (0.4%)	1
Myopia	1/450 (0.2%)	1	2/226 (0.9%)	2
Visual impairment	0/450 (0%)	0	1/226 (0.4%)	1
Gastrointestinal disorders
Abdominal discomfort	0/450 (0%)	0	1/226 (0.4%)	1
Abdominal pain	16/450 (3.6%)	17	7/226 (3.1%)	7
Abdominal pain upper	1/450 (0.2%)	1	2/226 (0.9%)	2
Constipation	0/450 (0%)	0	2/226 (0.9%)	2
Dental caries	6/450 (1.3%)	6	2/226 (0.9%)	2
Diarrhoea	6/450 (1.3%)	6	3/226 (1.3%)	3
Dyspepsia	0/450 (0%)	0	1/226 (0.4%)	1
Enteritis	0/450 (0%)	0	1/226 (0.4%)	1
Gastritis	4/450 (0.9%)	4	0/226 (0%)	0
Gastrointestinal disorder	118/450 (26.2%)	143	56/226 (24.8%)	66
Gastrooesophageal reflux disease	0/450 (0%)	0	1/226 (0.4%)	1
Gingivitis	1/450 (0.2%)	1	0/226 (0%)	0
Glossitis	1/450 (0.2%)	1	0/226 (0%)	0
Haemorrhoids	1/450 (0.2%)	1	0/226 (0%)	0
Hyperchlorhydria	2/450 (0.4%)	2	0/226 (0%)	0
Nausea	2/450 (0.4%)	2	2/226 (0.9%)	2
Oesophagitis	1/450 (0.2%)	1	0/226 (0%)	0
Peptic ulcer	1/450 (0.2%)	1	0/226 (0%)	0
Stomatitis	1/450 (0.2%)	1	0/226 (0%)	0
Toothache	6/450 (1.3%)	6	3/226 (1.3%)	3
Vomiting	2/450 (0.4%)	2	0/226 (0%)	0
General disorders
Asthenia	1/450 (0.2%)	1	1/226 (0.4%)	1
Chest discomfort	0/450 (0%)	0	1/226 (0.4%)	1
Chest pain	5/450 (1.1%)	5	1/226 (0.4%)	1
Fatigue	111/450 (24.7%)	130	42/226 (18.6%)	50
Influenza like illness	1/450 (0.2%)	1	0/226 (0%)	0
Injection site rash	0/450 (0%)	0	1/226 (0.4%)	1
Oedema peripheral	0/450 (0%)	0	1/226 (0.4%)	1
Pain	376/450 (83.6%)	779	168/226 (74.3%)	279
Pyrexia	147/450 (32.7%)	235	71/226 (31.4%)	110
Swelling	74/450 (16.4%)	86	27/226 (11.9%)	32
Immune system disorders
Hypersensitivity	0/450 (0%)	0	1/226 (0.4%)	1
Infections and infestations
Abscess	2/450 (0.4%)	2	0/226 (0%)	0
Abscess limb	1/450 (0.2%)	1	1/226 (0.4%)	1
Adenoiditis	1/450 (0.2%)	1	1/226 (0.4%)	1
Amoebiasis	1/450 (0.2%)	1	3/226 (1.3%)	3
Arthritis bacterial	1/450 (0.2%)	1	0/226 (0%)	0
Body tinea	7/450 (1.6%)	7	3/226 (1.3%)	3
Bronchitis	4/450 (0.9%)	4	4/226 (1.8%)	4
Bronchopneumonia	1/450 (0.2%)	1	0/226 (0%)	0
Candidiasis	1/450 (0.2%)	1	0/226 (0%)	0
Cellulitis	1/450 (0.2%)	1	0/226 (0%)	0
Chlamydial infection	1/450 (0.2%)	1	0/226 (0%)	0
Cutaneous larva migrans	1/450 (0.2%)	1	0/226 (0%)	0
Fungal infection	2/450 (0.4%)	2	1/226 (0.4%)	1
Fungal skin infection	4/450 (0.9%)	4	2/226 (0.9%)	2
Gastroenteritis	3/450 (0.7%)	3	1/226 (0.4%)	1
Giardiasis	1/450 (0.2%)	1	0/226 (0%)	0
Gingival infection	1/450 (0.2%)	1	0/226 (0%)	0
Helminthic infection	8/450 (1.8%)	8	1/226 (0.4%)	1
Hookworm infection	1/450 (0.2%)	1	1/226 (0.4%)	1
Hordeolum	1/450 (0.2%)	1	1/226 (0.4%)	1
Influenza	8/450 (1.8%)	8	1/226 (0.4%)	1
Malaria	56/450 (12.4%)	66	38/226 (16.8%)	44
Measles	0/450 (0%)	0	1/226 (0.4%)	1
Nasopharyngitis	9/450 (2%)	10	12/226 (5.3%)	12
Otitis media	0/450 (0%)	0	1/226 (0.4%)	1
Parasitic gastroenteritis	1/450 (0.2%)	1	0/226 (0%)	0
Paronychia	0/450 (0%)	0	1/226 (0.4%)	1
Pelvic inflammatory disease	4/450 (0.9%)	5	1/226 (0.4%)	1
Pericoronitis	1/450 (0.2%)	1	0/226 (0%)	0
Pharyngitis	2/450 (0.4%)	2	0/226 (0%)	0
Pneumonia	2/450 (0.4%)	2	3/226 (1.3%)	3
Respiratory tract infection	1/450 (0.2%)	1	1/226 (0.4%)	1
Rhinitis	1/450 (0.2%)	1	0/226 (0%)	0
Sepsis	0/450 (0%)	0	1/226 (0.4%)	1
Shigella infection	0/450 (0%)	0	1/226 (0.4%)	1
Sinusitis	1/450 (0.2%)	1	0/226 (0%)	0
Subcutaneous abscess	1/450 (0.2%)	1	0/226 (0%)	0
Tinea capitis	1/450 (0.2%)	1	0/226 (0%)	0
Tinea versicolour	1/450 (0.2%)	1	1/226 (0.4%)	1
Tonsillitis	4/450 (0.9%)	4	2/226 (0.9%)	2
Trichuriasis	1/450 (0.2%)	1	0/226 (0%)	0
Upper respiratory tract infection	10/450 (2.2%)	11	5/226 (2.2%)	5
Vaginal infection	2/450 (0.4%)	2	0/226 (0%)	0
Vaginitis bacterial	1/450 (0.2%)	1	0/226 (0%)	0
Varicella	1/450 (0.2%)	1	0/226 (0%)	0
Vulvitis	1/450 (0.2%)	1	2/226 (0.9%)	2
Vulvovaginal candidiasis	1/450 (0.2%)	1	0/226 (0%)	0
Injury, poisoning and procedural complications
Arthropod sting	1/450 (0.2%)	1	0/226 (0%)	0
Burns first degree	1/450 (0.2%)	1	0/226 (0%)	0
Human bite	0/450 (0%)	0	1/226 (0.4%)	1
Limb traumatic amputation	1/450 (0.2%)	1	0/226 (0%)	0
Soft tissue injury	1/450 (0.2%)	1	0/226 (0%)	0
Wound	2/450 (0.4%)	2	1/226 (0.4%)	1
Metabolism and nutrition disorders
Hypoglycaemia	0/450 (0%)	0	1/226 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	79/450 (17.6%)	97	36/226 (15.9%)	41
Back pain	4/450 (0.9%)	4	2/226 (0.9%)	2
Musculoskeletal chest pain	0/450 (0%)	0	1/226 (0.4%)	1
Musculoskeletal pain	1/450 (0.2%)	1	0/226 (0%)	0
Myalgia	90/450 (20%)	113	38/226 (16.8%)	46
Neck pain	1/450 (0.2%)	1	0/226 (0%)	0
Pain in extremity	2/450 (0.4%)	2	2/226 (0.9%)	2
Torticollis	1/450 (0.2%)	1	0/226 (0%)	0
Nervous system disorders
Dizziness	1/450 (0.2%)	1	0/226 (0%)	0
Head discomfort	1/450 (0.2%)	1	0/226 (0%)	0
Headache	201/450 (44.7%)	298	116/226 (51.3%)	157
Sensory disturbance	2/450 (0.4%)	2	0/226 (0%)	0
Psychiatric disorders
Anxiety	1/450 (0.2%)	1	0/226 (0%)	0
Insomnia	2/450 (0.4%)	2	1/226 (0.4%)	1
Renal and urinary disorders
Dysuria	1/450 (0.2%)	1	0/226 (0%)	0
Reproductive system and breast disorders
Amenorrhoea	0/450 (0%)	0	1/226 (0.4%)	1
Dysmenorrhoea	23/450 (5.1%)	25	10/226 (4.4%)	10
Genital discharge	1/450 (0.2%)	1	0/226 (0%)	0
Menstruation delayed	1/450 (0.2%)	1	0/226 (0%)	0
Metrorrhagia	1/450 (0.2%)	1	1/226 (0.4%)	1
Oligomenorrhoea	1/450 (0.2%)	1	0/226 (0%)	0
Ovarian cyst	0/450 (0%)	0	1/226 (0.4%)	1
Pelvic pain	3/450 (0.7%)	3	0/226 (0%)	0
Vaginal discharge	6/450 (1.3%)	6	4/226 (1.8%)	4
Vaginal haemorrhage	1/450 (0.2%)	1	1/226 (0.4%)	1
Vulvovaginal pruritus	1/450 (0.2%)	1	0/226 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy	0/450 (0%)	0	1/226 (0.4%)	1
Cough	13/450 (2.9%)	13	7/226 (3.1%)	8
Dysphonia	1/450 (0.2%)	1	0/226 (0%)	0
Oropharyngeal pain	8/450 (1.8%)	9	6/226 (2.7%)	6
Rhinorrhoea	1/450 (0.2%)	1	0/226 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis	0/450 (0%)	0	1/226 (0.4%)	1
Dermatitis allergic	0/450 (0%)	0	1/226 (0.4%)	1
Eczema	1/450 (0.2%)	1	0/226 (0%)	0
Pigmentation disorder	0/450 (0%)	0	1/226 (0.4%)	1
Pruritus	0/450 (0%)	0	1/226 (0.4%)	1
Rash	71/450 (15.8%)	84	33/226 (14.6%)	38
Rash papular	1/450 (0.2%)	1	0/226 (0%)	0
Skin disorder	0/450 (0%)	0	1/226 (0.4%)	1
Skin exfoliation	0/450 (0%)	0	1/226 (0.4%)	1
Urticaria	68/450 (15.1%)	81	28/226 (12.4%)	33
Vascular disorders
Hot flush	0/450 (0%)	0	1/226 (0.4%)	1
Hypotension	3/450 (0.7%)	3	2/226 (0.9%)	2
Orthostatic hypotension	0/450 (0%)	0	1/226 (0.4%)	1
Phlebitis	0/450 (0%)	0	1/226 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.