Trials / Completed
CompletedNCT00312858
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 653 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 15 Months
- Healthy volunteers
- Accepted
Summary
Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.
Detailed description
Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart. Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Comparator: VAQTA™ (Hepatitis A vaccine) | VAQTA™ 0.5 mL injection |
| BIOLOGICAL | Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) | ProQuad™ 0.5 mL injection |
| BIOLOGICAL | Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) | Prevnar™ 0.5 mL injection |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2006-04-11
- Last updated
- 2017-04-13
- Results posted
- 2009-08-03
Source: ClinicalTrials.gov record NCT00312858. Inclusion in this directory is not an endorsement.