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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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HPV-16/18 L1/AS04

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Koebenhavn NV, , Denmark

Site Status

GSK Investigational Site

Odense C, , Denmark

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Seinäjoki, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Heraklion, Crete, , Greece

Site Status

GSK Investigational Site

Thessaloniki, , Greece

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Kazan', , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Smolensk, , Russia

Site Status

GSK Investigational Site

Volgograd, , Russia

Site Status

Countries

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Denmark Estonia Finland Greece Netherlands Russia

References

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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.

Reference Type DERIVED

PMID: 35149535 (View on PubMed)

Study Documents

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