Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process
1 other identifier
interventional
770
6 countries
17
Brief Summary
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2004
Shorter than P25 for phase_3
17 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
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedSeptember 12, 2016
September 1, 2016
10 months
September 12, 2005
September 9, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.
Demonstration of non-inferiority in terms of immunogenicity of the HPV vaccine produced with a revised manufacturing process compared to the HPV vaccine produced with a previous manufacturing process
Secondary Outcomes (1)
Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.
Interventions
Eligibility Criteria
You may qualify if:
- A woman between, and including, 10 and 25 years of age at the time of the first vaccination.
- Written informed consent from the subject prior to enrolment.
- Subject must be free of obvious health problems.
- Subject must have negative urine pregnancy test.
You may not qualify if:
- Pregnant or breastfeeding.
- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
- History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
- Previous vaccination against human papillomavirus (HPV).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
Koebenhavn NV, 2400, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Tallinn, 1162, Estonia
GSK Investigational Site
Tartu, 50417, Estonia
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33200, Finland
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Athens, 11528, Greece
GSK Investigational Site
Heraklion, Crete, 71110, Greece
GSK Investigational Site
Thessaloniki, 54642, Greece
GSK Investigational Site
Rotterdam, 3011 EN, Netherlands
GSK Investigational Site
Rotterdam, 3015 GE, Netherlands
GSK Investigational Site
Kazan', 420015, Russia
GSK Investigational Site
Moscow, 115 478, Russia
GSK Investigational Site
Moscow, 119991, Russia
GSK Investigational Site
Smolensk, 214018, Russia
GSK Investigational Site
Volgograd, 400130, Russia
Related Publications (1)
Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669.
PMID: 35149535DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
September 1, 2004
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
September 12, 2016
Record last verified: 2016-09
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.