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

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.

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.