Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

GlaxoSmithKline814 enrolled

Overview

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

814

Conditions

Infections, Papillomavirus

Interventions

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) 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 the subject's LAR, and written informed assent must be obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects must not be pregnant. * Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception 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 vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12). * Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), 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 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 each dose of vaccine(s). Administration of routine vaccines may be allowed up to 8 days before the first dose * A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * Pregnant or breastfeeding women. * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * Previous administration of components of the investigational vaccine. * Previous vaccination against hepatitis A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period. * History of hepatitis A or B infection. * Known exposure to hepatitis A or B within the previous 6 weeks. * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * Cancer or autoimmune disease under treatment. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Locations (21)

GSK Investigational Site

Surrey, British Columbia, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Newmarket, Ontario, Canada

GSK Investigational Site

Sarnia, Ontario, Canada

GSK Investigational Site

Hoersholm, Denmark

GSK Investigational Site

Odense C, Denmark

GSK Investigational Site

Bordány, Hungary

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Budapest, Hungary

...and 11 more locations

Outcomes

Primary Outcomes

Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies

Seroconversion is defined as the appearance of anti-HAV antibodies \[i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)\] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.

Time frame: At Month 7

Anti-Heptatis A (HAV) Antibody Titers.

Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.

Time frame: At Month 7

Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies

A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.

Time frame: At Month 7

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

Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 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.

Time frame: At Month 7

Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Time frame: At Month 7

Secondary Outcomes

Anti-HBs Antibody Titers

Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.

Time frame: At Month 7

Number of Subjects Seroconverted for Anti-HBs Antibodies

Time frame: At month 7

Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years

Time frame: At Month 7

Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Time frame: At Month 7

Number of Subjects Seroconverted for Anti-HAV Antibodies

Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.