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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status.
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.
Time frame: At the pre-challenge time-point (Day 1)
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.
Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.
Time frame: At the pre-challenge time-point (Day 1)
Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine 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.
Time frame: 30 days (Day 31) after challenge dose
Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose.
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL .
Time frame: 30 days (Day 31) after challenge dose
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose.
Immunogenicity will be assessed in terms of GMC of anti-HAV antibody concentrations.
Time frame: 30 days (Day 31) after challenge dose
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Occurrence of solicited local and general symptoms.
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: 1. (mild) = An AE which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2. (moderate) = An AE which is sufficiently discomforting to interfere with normal everyday activities. 3. (severe) = An AE which prevents normal, everyday activities.
Time frame: During the 4-day (Days 1-4) follow-up period after the challenge dose
Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
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.
Time frame: During the 31-day (Days 1-31) follow-up period after the challenge dose
Occurrence of Serious Adverse Events (SAEs).
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.
Time frame: After the challenge dose up to the study end (Days 1-31)