Trials / Completed
CompletedNCT02062502
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 611 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 23 Months
- Healthy volunteers
- Accepted
Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VARIVAX™ New Seed Process | Varicella virus vaccine live manufactured with a new seed process |
| BIOLOGICAL | VARIVAX™ 2007 process | Varicella virus vaccine live manufactured with the 2007 process |
| BIOLOGICAL | M-M-R II™ | Measles, Mumps, and Rubella virus vaccine live |
Timeline
- Start date
- 2014-03-07
- Primary completion
- 2015-02-24
- Completion
- 2015-10-13
- First posted
- 2014-02-13
- Last updated
- 2018-10-30
- Results posted
- 2016-03-01
Source: ClinicalTrials.gov record NCT02062502. Inclusion in this directory is not an endorsement.