Safety study of herpes simplex vaccine in HSV seronegative and seropositive females between 10 and 17 years old
Trial overview
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 to Month 12
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: Within 7 days (Days 0-6) after each and any vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: Within 7 days (Days 0-6) after each and any vaccination
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within 30 days (Day 0-29) after any vaccination
Number of subjects with unsolicited adverse events (AEs) with medically attended visits
Timeframe: Within the 30 Day (Day 0-29) post-vaccination period
Number of subjects with new onset chronic diseases (NOCD)
Timeframe: During the active phase (up to Month 12)
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed
Timeframe: At months 7 and 12
Number of subjects with unsolicited adverse events (AEs) with medically attended visits
Timeframe: Starting from Day 30 until the end of study (Month 18)
Number of subjects with medically significant conditions (MSC)
Timeframe: During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)
Number of subjects with new onset chronic diseases (NOCD)
Timeframe: During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)
Number of subjects with serious adverse events (SAEs)
Timeframe: Up to month 18 (during active phase and ESFU period)
Anti-glycoprotein D (anti-gD) antibody concentrations
Timeframe: At months 0, 7 and 12
Anti-deacylated Monophosphoryl lipid A (anti-MPL) antibody concentrations
Timeframe: At months 0, 7 and 12
- 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.
- 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.
•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.
•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 location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.