Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18

• ClinicalTrials.gov Identifier: NCT00169494
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: September 12, 2016
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infections, Papillomavirus	Biological: HPV-16/18 L1/AS04	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 770 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: September 2004
• Actual Primary Completion Date: July 2005
• Actual Study Completion Date: July 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.
2. 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 :

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

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

Denmark

GSK Investigational Site

Koebenhavn NV, Denmark, 2400

GSK Investigational Site

Odense C, Denmark, 5000

Estonia

GSK Investigational Site

Tallinn, Estonia, 1162

GSK Investigational Site

Tartu, Estonia, 50417

Finland

GSK Investigational Site

Seinajoki, Finland, 60100

GSK Investigational Site

Tampere, Finland, 33200

Greece

GSK Investigational Site

Athens, Greece, 11527

GSK Investigational Site

Athens, Greece, 11528

GSK Investigational Site

Heraklion, Crete, Greece, 71110

GSK Investigational Site

Thessaloniki, Greece, 54642

Netherlands

GSK Investigational Site

Rotterdam, Netherlands, 3011 EN

GSK Investigational Site

Rotterdam, Netherlands, 3015 GE

Russian Federation

GSK Investigational Site

Kazan, Russian Federation, 420015

GSK Investigational Site

Moscow, Russian Federation, 115 478

GSK Investigational Site

Moscow, Russian Federation, 119991

GSK Investigational Site

Smolensk, Russian Federation, 214018

GSK Investigational Site

Volgograd, Russian Federation, 400130

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Month 18 FU 

Month 24 FU 

Month 36 FU 

Month 48 FU 

Study Data/Documents: Informed Consent Form 

Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 580299/012
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 580299/012
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkilä K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petäjä 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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00169494
• Other Study ID Numbers: 580299/012
• First Posted: September 15, 2005
• Last Update Posted: September 12, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.