Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel
Study Details
Study Description
Brief Summary
This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: HAV Group Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1). |
Biological: Havrix®
One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status. [At the pre-challenge time-point (Day 1)]
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.
- Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations. [At the pre-challenge time-point (Day 1)]
Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.
Secondary Outcome Measures
- Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose. [30 days (Day 31) after challenge dose]
Anti-HAV anamnestic response to the challenge dose is defined as: At least a 4-fold increase in anti-HAV antibody concentrations in subjects seropositive at the pre-challenge time-point. Anti-HAV antibody concentrations at least 4 time the assay cut-off (i.e.60 mIU/mL) in subjects seronegative at the pre-challenge time-point.
- Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose. [30 days (Day 31) after challenge dose]
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL .
- Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose. [30 days (Day 31) after challenge dose]
Immunogenicity will be assessed in terms of GMC of anti-HAV antibody concentrations.
- Occurrence of solicited local and general symptoms. [During the 4-day (Days 1-4) follow-up period after the challenge dose]
The following local (injection-site) AEs will be solicited: Pain at injection site, Redness at injection site, Swelling at injection site. The following general AEs will be solicited: Fatigue, Fever*, Gastrointestinal symptoms**, Headache. *Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity. **Gastrointestinal symptoms include nausea, vomiting, diarrhea and/or abdominal pain. The AEs will be categorized depending on their intensity into the following grades: (mild) = An AE which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (moderate) = An AE which is sufficiently discomforting to interfere with normal everyday activities. (severe) = An AE which prevents normal, everyday activities.
- Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. [During the 31-day (Days 1-31) follow-up period after the challenge dose]
Unsolicited AE covers any AE 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.
- Occurrence of Serious Adverse Events (SAEs). [After the challenge dose up to the study end (Days 1-31)]
SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
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Written informed consent obtained from the subject prior to performing any study specific procedure
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A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)
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Documented administration of 2 doses of Havrix® Junior in the second year of life
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Healthy subjects as established by medical history and clinical examination before entering into the study
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Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration
Exclusion Criteria:
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Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period
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Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
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Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
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Administration of long-acting immune-modifying drugs at any time during the study entry
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Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
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Administration of any hepatitis A vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects
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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
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History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
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Planned enrolment in the Israel Defense Forces within 30 days of study enrolment or activity that would prohibit the subject to return for Visit 2
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Acute disease and/or fever at the time of enrolment Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity Subjects with a minor illness without fever may be enrolled at the discretion of the investigator
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Pregnant or lactating female
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Female planning to become pregnant or planning to discontinue contraceptive precautions
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 116762