Immunogenicity and Safety Study of GlaxoSmithKline Biolog... | NCT01462357

ID	Type	Description	Link
2011-002035-26	EudraCT Number

Label	Type	Description	Intervention Names
Cervarix 2 dose Group	Experimental	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.	Biological: Cervarix Drug: Placebo
Gardasil 2 dose Group	Experimental	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.	Biological: Gardasil Drug: Placebo
Gardasil 3 dose Group	Experimental	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.	Biological: Gardasil

Name	Type	Description	Arm Group Labels	Other Names
Cervarix	Biological	2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity	Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.	At Month 7 (i.e. one month after the last dose of study vaccine)
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity	Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.	At Month 7 (i.e. one month after the last dose of study vaccine)
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)	Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.	At Month 7 (i.e. one month after the last dose of study vaccine)

Secondary Outcomes

Measure	Description	Time Frame
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA	Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.	At Day 0 and Months 12, 18, 24 and 36
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol.
A female between, and including, 9 and 14 years of age at the time of the first vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, if capable, the subject should sign and personally date a written informed assent.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion Criteria:

Pregnant or breastfeeding.
A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol.
Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 36).
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
Cancer or autoimmune disease under treatment.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
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).
Previous administration of vaccine components.
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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
Acute disease and/or fever at the time of enrolment.
Drug and/or alcohol abuse.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Dax		40100	France
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
26062002	Background	Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, Rombo L, Tan NC, Rouzier R, Friel D, De Muynck B, De Simoni S, Suryakiran P, Hezareh M, Folschweiller N, Thomas F, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689-702. doi: 10.1080/21645515.2015.1050570.
29174109

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

ID	Type	URL	Comment
115411	Dataset Specification	View IPD

ID	Title	Description
FG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
FG001	Gardasil 2 Dose Group

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity

Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.

The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.

Posted

Count of Participants

Participants

At Month 7 (i.e. one month after the last dose of study vaccine)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Units	Counts
Participants	OG000334 OG001331 OG002333

Title

Denominators

Categories

Anti-HPV-16

- ParticipantsOG000330
- ParticipantsOG001327
- ParticipantsOG002322

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.					Difference in SCR	0			2-Sided	95	-1.16	1.15					Non-Inferiority	Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.

Primary

Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity

Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Month 7 (i.e. one month after the last dose of study vaccine)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Primary

Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)

Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.

The analysis was based on the TVC which included all subjects, regardless of serostatus, who received at least one dose of vaccine in this study and for whom data were available at the specified time point.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Month 7 (i.e. one month after the last dose of study vaccine)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA

Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.

The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.

Posted

Count of Participants

Participants

At Day 0 and Months 12, 18, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Anti-HPV-16/18 Antibody Titers as Assessed by ELISA

Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Day 0 and Months 12, 18, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36

Data at Month 36 were also expressed as International Units per milliliter (IU/mL). Conversion factor from EU/mL to IU/mL was determined to be 1/6.1 for HPV-16 and 1/5.7 for HPV-18, using the WHO International Standards (NIBSC codes 05-134 and 10-140 for HPV-16 and HPV-18, respectively). The assay cut-offs were therefore 3.1 IU/mL and 3.2 IU/mL for anti-HPV-16 and anti-HPV-18 antibodies, respectively.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002

Secondary

Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity

Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.

The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a subset of approximately 100 subjects per study group, who returned for blood sampling at Month 36, for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.

Posted

Count of Participants

Participants

At Day 0 and Months 7, 12, 18, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002

Secondary

Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity

Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0 and Months 7, 12, 18, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group

Secondary

Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC

The analysis was based on the Month 36 TVC, which included a subset of approximately 100 subjects per study group, who received at least one dose of vaccine in this study, for whom data were available at the specified time points and who were seronegative before vaccination.

Posted

Count of Participants

Participants

At Day 0 and Months 7, 12, 18, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group

Secondary

Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC

Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0 and Months 7, 12, 18, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)

Among immune markers expressed were Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L). The assay was performed on a sub-cohort of approximately 100 subjects per study group.

The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a sub-cohort of approximately 100 subjects per study group, who returned for blood sampling at Month 36 and for whom data concerning immunogenicity outcome measures were available at the specified time point.

Posted

Median

Inter-Quartile Range

T-cells/million cells

At Day 0 and Months 7, 12, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group

Secondary

B-cell-mediated Immune Responses in the Sub-cohort for CMI

The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented. The assay was performed on a sub-cohort of approximately 100 subjects per study group.

Posted

Median

Inter-Quartile Range

B-cells/million cells

At Day 0 and Months 7, 12, 24 and 36

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and who had their symptom sheet completed.

Posted

Count of Participants

Participants

During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group

Secondary

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

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

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and who had their symptom sheet completed.

Posted

Count of Participants

Participants

During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

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

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

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)

pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

From Day 0 up to Month 12

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Number of Subjects With Medically Significant Conditions (MSCs)

MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

From Day 0 up to Month 36 (throughout the study period)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

From Day 0 up to Month 36 (throughout the study period)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related = an event assessed by the investigator as causally related to the investigational product, to study participation or to GSK concomitant products.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

From Day 0 up to Month 36 (throughout the study period)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group

Secondary

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant congenital anomaly (CA), Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.

The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.

Posted

Count of Participants

Participants

From Day 0 up to Month 36 (throughout the study period)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Number of Subjects Using a Concomitant Medication Throughout the Study Period

The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Secondary

Number of Subjects Completing the Vaccination Schedule

The number of subjects who have completed the three-dose vaccination schedule in all groups.

The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.

Posted

Count of Participants

Participants

From Day 0 up to Month 36 (throughout the study period)

ID	Title	Description
OG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
OG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Anaphylactic shock	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Completed suicide	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Epilepsy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Influenza	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Lung abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Mouth cyst	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Peritonitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Post procedural infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Presyncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Seizure	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Tension headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Teratoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Tonsillitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected358 at risk EG0020 events0 affected358 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk
Viral infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected358 at risk EG0020 events0 affected358 at risk
Vulval ulceration	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected359 at risk EG0010 events0 affected358 at risk EG0021 events1 affected358 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00098 events68 affected359 at risk EG001119 events82 affected358 at risk EG002108 events67 affected358 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG000370 events191 affected359 at risk EG001261 events135 affected358 at risk EG002288 events157 affected358 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG000374 events192 affected359 at risk EG001359 events199 affected358 at risk EG002390 events193 affected358 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00069 events55 affected359 at risk EG001103 events74 affected358 at risk EG00291 events70 affected358 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG000241 events149 affected359 at risk EG001213 events134 affected358 at risk EG002232 events152 affected358 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG000267 events166 affected359 at risk EG001230 events144 affected358 at risk EG002254 events136 affected358 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00010 events8 affected359 at risk EG00112 events11 affected358 at risk EG00222 events20 affected358 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG000784 events329 affected359 at risk EG001613 events277 affected358 at risk EG002669 events295 affected358 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG00070 events59 affected359 at risk EG00171 events64 affected358 at risk EG00265 events53 affected358 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00032 events26 affected359 at risk EG00117 events16 affected358 at risk EG00223 events18 affected358 at risk
Swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG000288 events163 affected359 at risk EG001146 events98 affected358 at risk EG002200 events118 affected358 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00031 events27 affected359 at risk EG00133 events29 affected358 at risk EG00234 events31 affected358 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00036 events28 affected359 at risk EG00116 events13 affected358 at risk EG00233 events25 affected358 at risk

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D014412	Tumor Virus Infections
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C510352	human papillomavirus vaccine, L1 type 16, 18
D000068857	Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D053918	Papillomavirus Vaccines
D014765	Viral Vaccines

ID	Title	Description
BG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
BG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
BG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cervarix 2 Dose Group	Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.	0	359	21	359	343	359
EG001	Gardasil 2 Dose Group	Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.	0	358	11	358	321	358
EG002	Gardasil 3 Dose Group	Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.	1	358	14	358	324	358