Trials / Terminated
TerminatedNCT00839917
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 23 Months
- Healthy volunteers
- Accepted
Summary
This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™) | Single administration of 0.5 mL subcutaneous injection |
| BIOLOGICAL | M-M-R™ II and Varivax™ | Single administration of 0.5 mL subcutaneous injection |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2009-02-10
- Last updated
- 2017-04-12
- Results posted
- 2012-10-10
Source: ClinicalTrials.gov record NCT00839917. Inclusion in this directory is not an endorsement.