A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2-AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.

GlaxoSmithKline1 site in 1 country5,960 target enrollmentApril 7, 2004

ConditionsHerpes Simplex

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Herpes Simplex
Sponsor: GlaxoSmithKline
Enrollment: 5960
Locations: 1
Primary Endpoint: Number of Subjects With Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).

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

Detailed Description

Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months.

Registry

clinicaltrials.gov

Start Date

April 7, 2004

End Date

July 24, 2007

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
•Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
•Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
•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. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.

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.
•Pregnant or lactating female.
•Female planning to become pregnant or likely to become pregnant during the first eight months of the study (months 0-8).
•Any previous confirmed history of, or current clinical signs or symptoms of, oro labial herpes (cold sores), herpetic whitlow or genital herpes disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, dysuria or pain, burning, itching, tingling in the ano-genital area.
•History of previous or planned vaccination against hepatitis A or a history of hepatitis A infection.
•Previous vaccination against herpes.
•History of herpetic keratitis.
•History of multiform erythema.
•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 with the following exceptions: administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before and 30 days after the first dose of study vaccine.
•History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines

Outcomes

Primary Outcomes

Number of Subjects With Serious Adverse Events (SAEs)

Time Frame: From Month 0 to Month 12

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Secondary Outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 7 days (Days 0-6) after each and any vaccination)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 7 days (Days 0-6) after each and any vaccination)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Day 0-29) after any vaccination)
Number of Subjects With Serious Adverse Events (SAEs)(Up to month 18 (during active phase and ESFU period))
Number of Subjects With New Onset Chronic Diseases (NOCD)(During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18))
Number of Subjects With Medically Significant Conditions (MSC)(During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18))
Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits(Starting from Day 30 until the end of study (Month 18))
Anti-glycoprotein D (Anti-gD) Antibody Concentrations(At months 0, 7 and 12)
Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations(At months 0, 7 and 12)
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed(At months 7 and 12)