Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Intervention: GSK208141; Havrix (investigational formulation); Placebo
Intervention description: 3 intramuscular doses; 3 intramuscular doses; 3 intramuscular doses
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5960.0
Sex: Female
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Simplex vaccine; Safety; Adolescents; Immunogenicity

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.
    

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

          -  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.