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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Biological: HPV-16/18 L1/AS04

• Study Type: Interventional
• Enrollment (Actual): 770
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Koebenhavn NV, Denmark, 2400
    • GSK Investigational Site
  • Odense C, Denmark, 5000
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 1162
    • GSK Investigational Site
  • Tartu, Estonia, 50417
    • GSK Investigational Site
• Finland
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33200
    • GSK Investigational Site
• Greece
  • Athens, Greece, 11528
    • GSK Investigational Site
  • Athens, Greece, 11527
    • GSK Investigational Site
  • Heraklion, Crete, Greece, 71110
    • GSK Investigational Site
  • Thessaloniki, Greece, 54642
    • GSK Investigational Site
• Netherlands
  • Rotterdam, Netherlands, 3011 EN
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3015 GE
    • GSK Investigational Site
• Russian Federation
  • Kazan, Russian Federation, 420015
    • GSK Investigational Site
  • Moscow, Russian Federation, 119991
    • GSK Investigational Site
  • Moscow, Russian Federation, 115 478
    • GSK Investigational Site
  • Smolensk, Russian Federation, 214018
    • GSK Investigational Site
  • Volgograd, Russian Federation, 400130
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Month 18 FU
• Month 24 FU
• Month 36 FU
• Month 48 FU

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 580299/012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: 580299/012
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 580299/012 are summarised with studies 107476 (M18), 107477 (M24), and 107479 (M36) on the GSK Clinical Study Register.