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

Completed · Phase 3 · Has a placebo group

Conditions studied: Herpes Simplex

In brief

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.

Key facts

Study ID

NCT00224484

Run by

GlaxoSmithKline

People needed

5960

Starts

2004-04-07

Expected to finish

2007-07-24

Last updated by the study team

2019-01-07

Who can join

Age: 10 and older, up to 17. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Tempe, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Littleton, Colorado, United States
• GSK Investigational Site — Thornton, Colorado, United States
• GSK Investigational Site — Westminster, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Cocoa Beach, Florida, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Naples, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Arkansas City, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Towson, Maryland, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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