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

GlaxoSmithKline5,960 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

5,960

Conditions

Herpes Simplex

Interventions

GSK208141BIOLOGICAL

3 intramuscular doses

Havrix (investigational formulation)BIOLOGICAL

3 intramuscular doses

PlaceboBIOLOGICAL

3 intramuscular doses

Eligibility

Sex: FEMALEMin age: 10 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (151)

Outcomes

Primary Outcomes

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: From Month 0 to Month 12

Secondary Outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (\>) 30mm diameter and persisting more than 24 hours.

Time frame: Within 7 days (Days 0-6) after each and any vaccination

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.

Time frame: Within 7 days (Days 0-6) after each and any vaccination

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.

Data from ClinicalTrials.gov

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GSK Investigational Site

Birmingham, Alabama, United States

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

...and 141 more locations

Time frame: Within 30 days (Day 0-29) after any vaccination

Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits

Time frame: Within the 30 Day (Day 0-29) post-vaccination period

Number of Subjects With New Onset Chronic Diseases (NOCD)

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Time frame: During the active phase (up to Month 12)