Trials / Completed
CompletedNCT01600092
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,020 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RotaTeq™ experimental formulation | |
| BIOLOGICAL | RotaTeq™ existing formulation |
Timeline
- Start date
- 2013-04-29
- Primary completion
- 2014-03-25
- Completion
- 2014-03-25
- First posted
- 2012-05-16
- Last updated
- 2018-11-14
- Results posted
- 2015-03-19
Source: ClinicalTrials.gov record NCT01600092. Inclusion in this directory is not an endorsement.