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Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine Administered Intramuscularly ( 0, 1, 6 Month Schedule) in Healthy Women From Malaysia.


Phase 3
18 Years
35 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Associated Cervical Neoplasia, Papillomavirus Vaccines

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Trial Information

Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine Administered Intramuscularly ( 0, 1, 6 Month Schedule) in Healthy Women From Malaysia.


The protocol was primarily amended for the following reasons:

- Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming
commercially available in an increasing number of countries. Therefore, the study
procedures were revised to include questions at every visit to determine if subjects
have received an HPV vaccine outside of the study.

- It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control
group at the end of the study. The HPV vaccine will be offered to these subjects based
on its local indication once the vaccine is marketed in Malaysia.


Inclusion Criteria:



- 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 from Malaysia 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 an effective method of birth control for 30 days prior to vaccination
and must agree to continue such precautions for two months after completion of the
vaccination series.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- Chronic administration (defined as more than 14 days) 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 before and 30 days after the first dose of vaccine. Administration of
routine vaccines up to 8 days before the first dose of study vaccine is allowed.
Enrolment will be deferred until the subject is outside of specified window.

- previous administration of components of the investigational vaccine

- Previous vaccination against HPV or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine(s).

- Hypersensitivity to latex.

- Acute disease at the time of enrolment.

- Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular,
hepatic or renal functional 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(s) or planned administration during the
study period. Enrolment will be deferred until the subject is outside of specified
window.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

Outcome Description:

Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Outcome Time Frame:

At Month 7

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Malaysia: Ministry of Health

Study ID:

105926

NCT ID:

NCT00345878

Start Date:

September 2006

Completion Date:

December 2007

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • Associated Cervical Neoplasia
  • Papillomavirus Vaccines
  • HPV-16/18 L1 VLP AS04
  • Cervical neoplasia
  • Cervical cancer
  • Human Papillomavirus (HPV)
  • Double-blind
  • AS04
  • Neoplasms

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