Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
2 other identifiers
interventional
1,079
4 countries
21
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedStudy Start
First participant enrolled
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2015
CompletedResults Posted
Study results publicly available
March 28, 2016
CompletedNovember 15, 2019
October 1, 2019
3.9 years
October 27, 2011
August 11, 2014
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (19)
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
At Day 0 and Months 12, 18, 24 and 36
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
At Day 0 and Months 12, 18, 24 and 36
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36
At Month 36
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
At Day 0 and Months 7, 12, 18, 24 and 36
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
At Day 0 and Months 7, 12, 18, 24 and 36
- +14 more secondary outcomes
Study Arms (3)
Cervarix 2 dose Group
EXPERIMENTALSubjects 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.
Gardasil 2 dose Group
EXPERIMENTALSubjects 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.
Gardasil 3 dose Group
EXPERIMENTALSubjects 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.
Interventions
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.
2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.
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 Month 2 to maintain blinding.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (21)
GSK Investigational Site
Dax, 40100, France
GSK Investigational Site
Draguignan, 83300, France
GSK Investigational Site
Essey-lès-Nancy, 54270, France
GSK Investigational Site
Le Havre, 76620, France
GSK Investigational Site
Nice, 06300, France
GSK Investigational Site
Paris, 75970, France
GSK Investigational Site
Rosiers-d'Égletons, 19300, France
GSK Investigational Site
Saint Cyr Sur Loir, 37540, France
GSK Investigational Site
Seysses, 31600, France
GSK Investigational Site
Tours, 37100, France
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Singapore, 119074, Singapore
GSK Investigational Site
Singapore, 169608, Singapore
GSK Investigational Site
Singapore, 228510, Singapore
GSK Investigational Site
Singapore, 229899, Singapore
GSK Investigational Site
Singapore, 529889, Singapore
GSK Investigational Site
Singapore, 768826, Singapore
GSK Investigational Site
Eskilstuna, SE-631 88, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Örebro, SE-701 16, Sweden
Related Publications (3)
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.
PMID: 26062002BACKGROUNDLeung TF, Liu AP, Lim FS, Thollot F, Oh HML, Lee BW, Rombo L, Tan NC, Rouzier R, De Simoni S, Suryakiran P, Hezareh M, Thomas F, Folschweiller N, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years: Results to month 36 from a randomized trial. Vaccine. 2018 Jan 2;36(1):98-106. doi: 10.1016/j.vaccine.2017.11.034. Epub 2017 Nov 23.
PMID: 29174109BACKGROUNDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2011
First Posted
October 31, 2011
Study Start
November 21, 2011
Primary Completion
October 27, 2015
Study Completion
October 27, 2015
Last Updated
November 15, 2019
Results First Posted
March 28, 2016
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below).
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD is available via the Clinical Study Data Request site (click on the link provided below).