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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAV Group | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Havrix® | Biological | One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At the pre-challenge time-point (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 . | 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. | 30 days (Day 31) after challenge dose |
| 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:
| 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. | 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. | After the challenge dose up to the study end (Days 1-31) |
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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