Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

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).

Official Title

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.

Conditions

Herpes Simplex

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Further Details

Primary Outcome Measures:

• Occurrence of Serious Adverse Events throughout the study period (up to month 12).

Secondary Outcome Measures:

• Solicited general and local symptoms within 7 days after vaccination; unsolicited symptoms within 30 days after vaccination; new onset chronic diseases; abnormal biochemical and haematological parameters at months 0, 7 and 12; SAEs up to month 18.

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 Havrix vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months.

Study Start

April 2004

Eligibility & Criteria

• Ages Eligible for Study: 10 Years -17 Years
• Genders Eligible for Study: Female
• Accepts Healthy Volunteers

Inclusion Criteria:

• A 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.
• Subjects of childbearing potential at the time of study entry must be abstinent or must be using an effective method of birth control.
• Free of obvious health problems as established by history-directed physical examination before entering into the study.

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 (as determined by the investigator) 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.

Total Enrolment

6000

Contact Details

Location:

• South Brisbane, Australia

Contact GlaxoSmithKline for more information.