Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women

NCT ID: NCT00344032

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-28
• Study Completion Date: 2007-12-04

Brief Summary

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 evaluate the immune response induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cervarix

Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).

Group Type: EXPERIMENTAL

HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Placebo

Subjects who received 3 doses of Placebo (at 0, 1, 6 months).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Interventions

Placebo

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Intervention Type: BIOLOGICAL

HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK Biologicals' HPV-16/18 VLP/AS04 vaccine

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A female between, and including, 18 and 35 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects must have a negative urine pregnancy test.
• Subjects of childbearing potential at the time of study entry must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/ control within 30 days preceding the first dose of study vaccine/ control, or planned use during the study period.
• Pregnant or breastfeeding.
• Planning to become pregnant or likely to become pregnant.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (Days 1 to 30) before and 30 days (Day 0- Day 29) after the first dose of vaccine. Administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before the first dose of study vaccine is allowed.
• Previous administration of components of the investigational vaccine.
• Previous vaccination against HPV.
• Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
• Hypersensitivity to latex.
• Known acute or chronic, clinically significant neurologic, hepatic or renal functional pulmonary, cardiovascular abnormality, as determined by previous physical examination or laboratory tests.
• History of chronic condition(s) requiring treatment.
• Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine/ control or planned administration during the study period. Enrolment will be deferred until condition is resolved.
• Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Chandigarh, , India

GSK Investigational Site

Kolkata, , India

GSK Investigational Site

Mumbai, , India

GSK Investigational Site

New Delhi, , India

Countries

India

References

Bhatla N, Suri V, Basu P, Shastri S, Datta SK, Bi D, Descamps DJ, Bock HL; Indian HPV Vaccine Study Group. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women. J Obstet Gynaecol Res. 2010 Feb;36(1):123-32. doi: 10.1111/j.1447-0756.2009.01167.x.

Reference Type: BACKGROUND

PMID: 20178538 (View on PubMed)

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

Reference Type: BACKGROUND

PMID: 18845199 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

104479

Identifier Type: -

Identifier Source: org_study_id