Trials / Completed
CompletedNCT02012998
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 751 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 10 Years – 12 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HBVAXPRO 5µg | 0.5mL intramuscular injection |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2013-12-17
- Last updated
- 2017-09-11
Locations
10 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02012998. Inclusion in this directory is not an endorsement.