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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Herpes Simplex

Treatments: Biological: GSK208141; Biological: Placebo; Biological: Havrix (investigational formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224484

208141/040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,960 patients

Sex: Female

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
• History of a current acute or chronic autoimmune disease.
• History of any neurological disorders or seizures, with the exception of a single febrile seizure during childhood.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
• Acute disease at the time of enrolment
• Oral temperature >= 37.5°C (99.5°F) / axillary temperature >= 37.5°C (99.5°F) at the time of enrolment.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5,960 participants in 3 patient groups, including a placebo group

GD2-AS04 GROUP

Experimental group

Description:

Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.

Treatment:

Biological: GSK208141

HAVRIX GROUP

Active Comparator group

Description:

Female subjects aged 10-17 years, who received 3 doses of Havrix, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.

Treatment:

Biological: Havrix (investigational formulation)

SALINE GROUP

Placebo Comparator group

Description:

Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.

Treatment:

Biological: Placebo