Trials / Completed
CompletedNCT00480324
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 765 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 14 Weeks
- Healthy volunteers
- Accepted
Summary
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus \[HRV\] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotarix | Two-dose oral vaccination. |
| BIOLOGICAL | Placebo | Two-dose oral administration. |
Timeline
- Start date
- 2007-06-19
- Primary completion
- 2009-03-31
- Completion
- 2009-11-21
- First posted
- 2007-05-30
- Last updated
- 2020-01-02
- Results posted
- 2010-11-17
Locations
20 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00480324. Inclusion in this directory is not an endorsement.