Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-28

Study Completion Date

2007-03-01

Brief Summary

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Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

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Detailed Description

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Conditions

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Infections, Papillomavirus Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cervarix Lot1 Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

Cervarix™

Intervention Type BIOLOGICAL

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Cervarix Lot2 Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

Cervarix™

Intervention Type BIOLOGICAL

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Cervarix Lot3 Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

Cervarix™

Intervention Type BIOLOGICAL

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Cervarix Low Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Group Type EXPERIMENTAL

Cervarix™

Intervention Type BIOLOGICAL

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Interventions

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Cervarix™

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Subject must have a negative urine pregnancy test.
* Healthy subject before entering the study entry as established by medical history and physical examination.
* Subject must be of non-childbearing potential.

Exclusion Criteria

* pregnant or breastfeeding subject.
* previous vaccination against human papillomavirus (HPV).
* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.

Minimum Eligible Age

18 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

Hvidovre, , Denmark

Site Status

GSK Investigational Site

Kaunas, , Lithuania

Site Status

GSK Investigational Site

Klaipėda, , Lithuania

Site Status

GSK Investigational Site

Vilnius, , Lithuania

Site Status

GSK Investigational Site

Vilnius, , Lithuania

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

Countries

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Denmark Lithuania Poland

References

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Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.

Reference Type BACKGROUND

PMID: 19221517 (View on PubMed)

Study Documents

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