Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
1 other identifier
interventional
814
4 countries
21
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
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
Study Start
First participant enrolled
December 15, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2009
CompletedResults Posted
Study results publicly available
January 6, 2010
CompletedAugust 17, 2018
October 1, 2016
12 months
December 20, 2007
November 27, 2009
June 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
Seroconversion is defined as the appearance of anti-HAV antibodies \[i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)\] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
At Month 7
Anti-Heptatis A (HAV) Antibody Titers.
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
At Month 7
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
At Month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
At Month 7
Secondary Outcomes (16)
Anti-HBs Antibody Titers
At Month 7
Number of Subjects Seroconverted for Anti-HBs Antibodies
At month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
At Month 7
Number of Subjects Seroconverted for Anti-HAV Antibodies
One month after the second dose of vaccine
- +11 more secondary outcomes
Study Arms (3)
Cervarix™ & Twinrix™ Group
EXPERIMENTALSubjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
Cervarix™ Group
EXPERIMENTALSubjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
Twinrix™ Group
ACTIVE COMPARATORSubjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
Interventions
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must not be pregnant.
- Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
You may not qualify if:
- 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).
- Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
- A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding women.
- 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.
- Previous vaccination against hepatitis A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
- History of hepatitis A or B infection.
- Known exposure to hepatitis A or B within the previous 6 weeks.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (21)
GSK Investigational Site
Surrey, British Columbia, V3R 8P8, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Hoersholm, 2970, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Bordány, 6795, Hungary
GSK Investigational Site
Budapest, 1032, Hungary
GSK Investigational Site
Budapest, 1033, Hungary
GSK Investigational Site
Budapest, 1039, Hungary
GSK Investigational Site
Budapest, 1089, Hungary
GSK Investigational Site
Győr, 9024, Hungary
GSK Investigational Site
Hódmezővásárhely, 6800, Hungary
GSK Investigational Site
Szeged, 6723, Hungary
GSK Investigational Site
Szombathely, 9700, Hungary
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Lycksele, SE-921 82, Sweden
GSK Investigational Site
Örebro, SE-702 11, Sweden
GSK Investigational Site
Umeå, SE-901 85, Sweden
Related Publications (3)
Pedersen C, Breindahl M, Aggarwal N, Berglund J, Oroszlan G, Silfverdal SA, Szuts P, O'Mahony M, David MP, Dobbelaere K, Dubin G, Descamps D. Randomized trial: immunogenicity and safety of coadministered human papillomavirus-16/18 AS04-adjuvanted vaccine and combined hepatitis A and B vaccine in girls. J Adolesc Health. 2012 Jan;50(1):38-46. doi: 10.1016/j.jadohealth.2011.10.009.
PMID: 22188832BACKGROUNDPederson C et al. Co-administration of ASO4- adjuvanted human papillomavirus- 16/18 cervical cancer vaccine with inactivated hepatitis A ans B vaccine in girls aged 9-15 years. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 19-22 November 2009.
BACKGROUNDBergman 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
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 21, 2007
Study Start
December 15, 2007
Primary Completion
December 1, 2008
Study Completion
April 28, 2009
Last Updated
August 17, 2018
Results First Posted
January 6, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.