Trials / Completed
CompletedNCT02093260
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 405 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 6 Months – 11 Years
- Healthy volunteers
- Accepted
Summary
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Detailed description
Too see percentage of subjects with HI titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Vaccine | Flubio (Influenza HA) Vaccine The vaccine will be given intramuscularly. |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-07-01
- Completion
- 2014-12-01
- First posted
- 2014-03-20
- Last updated
- 2015-04-29
Locations
2 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT02093260. Inclusion in this directory is not an endorsement.