Trials / Withdrawn
WithdrawnNCT03183492
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
Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 19 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Havrix® | One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
Timeline
- Start date
- 2018-05-07
- Primary completion
- 2019-01-28
- Completion
- 2019-01-28
- First posted
- 2017-06-12
- Last updated
- 2018-03-02
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03183492. Inclusion in this directory is not an endorsement.