Trials / Completed
CompletedNCT00560755
Safety Study of ProQuad® rHA in Infants (V221-037)
An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,388 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 22 Months
- Healthy volunteers
- Accepted
Summary
Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life. Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ProQuad® | ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses. |
Timeline
- Start date
- 2007-10-24
- Primary completion
- 2008-11-24
- Completion
- 2008-11-24
- First posted
- 2007-11-20
- Last updated
- 2017-10-17
- Results posted
- 2017-10-17
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00560755. Inclusion in this directory is not an endorsement.