Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine

Exclusion Criteria

• •Pregnant or lactating female.
• •Female planning to become pregnant during the first eight months of the study
• •Any previous history of, or current clinical signs or symptoms of oro-labial (cold sores), genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling, or dysuria.
• •Previous vaccination against herpes.
• •History of erythema multiforme.
• •Use of any investigational or non-registered 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.
• •Planned administration/administration of a non-study vaccine within 30 days before and 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 the first dose of study vaccine is allowed.
• •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, including human immunodeficiency virus (HIV) infection.
• •History of a current acute or chronic autoimmune disease.
• •History of any neurologic 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, as determined by medical history or physical examination.
• •Acute disease at the time of enrolment
• •Oral temperature ≥99.5°F (\> 37.5°C) / axillary temperature ≥99.5°F (\> 37.5°C) 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 or planned use during the study period
• •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.