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
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|ClinicalTrials.gov Identifier: NCT03183492|
Recruitment Status : Withdrawn (Sponsor cancelled the study as real life impact data has already shown the value of HepA vaccination & as no critical need to gather additional data in Israel.)
First Posted : June 12, 2017
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis A||Biological: Havrix®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program|
|Estimated Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||January 28, 2019|
|Estimated Study Completion Date :||January 28, 2019|
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).
One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Other Name: GSK Biologicals' inactivated hepatitis A vaccine
- Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status. [ Time Frame: 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. [ Time Frame: At the pre-challenge time-point (Day 1) ]Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.
- Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183492
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|