Trials / Completed
CompletedNCT00496054
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotavirus Vaccine, Live, Oral, Pentavalent | Pentavalent vaccine 9G1, G2, G3, G4 \& P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2. |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2008-10-01
- Completion
- 2008-10-01
- First posted
- 2007-07-04
- Last updated
- 2017-04-13
- Results posted
- 2010-03-11
Source: ClinicalTrials.gov record NCT00496054. Inclusion in this directory is not an endorsement.