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Phase 3, Open, Age-stratified Study to Assess Immunogenicity & Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up


Phase 3
15 Years
55 Years
Not Enrolling
Female
Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection

Thank you

Trial Information

Phase 3, Open, Age-stratified Study to Assess Immunogenicity & Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

Inclusion Criteria


Inclusion criteria for primary study:

- A woman who the investigator believes that she and/or her parents/legally acceptable
representative can and will comply with the requirements of the protocol.

- A woman between, and including, 15 and 55 years of age at the time of the first
vaccination.

- Written informed consent obtained from the subject prior to enrolment (for subjects
below the legal age of consent, written informed consent must be obtained from a
parent or legally acceptable representative and, in addition, the subject should sign
and personally date a written informed assent).

- Free of obvious health problems.

- Subject must have a negative urine pregnancy test.

- Subject must be of non-childbearing potential or, if of childbearing potential, she
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. Subjects who reach menarche during the study
and therefore become of childbearing potential must agree to follow the same
precautions

Inclusion criteria for extension studies

- A female who enrolled in the primary study and received three doses of vaccine.

- Written informed consent obtained from the subject prior to enrolment (for subjects
below the legal age of consent, written informed consent must be obtained from a
parent or legally acceptable representative and, in addition, the subject must sign
and personally date a written informed assent).

Exclusion criteria for primary study:

- Pregnant or breastfeeding.

- A woman planning to become pregnant, likely to become pregnant (as determined by the
investigator) or planning to discontinue contraceptive precautions during the study
period, up to two months after the last vaccine dose.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned
use during the study period (up to Month 12).

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose, or planned administration during the
study period.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days before and 30 days after the first dose of study vaccine. Planned
administration/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.

- 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 vaccine.

- Hypersensitivity to latex.

- Known acute or chronic, clinically significant neurologic, 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 3 months preceding
the first dose of study vaccine or planned administration during the study period.
Enrolment will be deferred until the subject is outside of specified window.

- Acute disease at the time of enrolment.

Exclusion criteria for extension studies

- Use of any investigational or non-registered product (drug or vaccine) or planned use
during the study period.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device).

- Chronic administration of immunosuppressants or other immune-modifying drugs
occurring less than 3 months prior to blood sampling.

- Administration of immunoglobulins and/or any blood products within the three months
preceding blood sampling.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age

Outcome Description:

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 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. Seroconversion at Month 7 was a secondary outcome measure as per protocol for Cervarix (46-55 Years) Group.

Outcome Time Frame:

At Month 7

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK

Study ID:

103514

NCT ID:

NCT00196937

Start Date:

October 2004

Completion Date:

February 2009

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Human Papillomavirus Infection
  • HPV Vaccine Safety
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Warts
  • Carcinoma in Situ
  • Papillomavirus Infections

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