Trials / Completed
CompletedNCT00197015
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,474 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 13 Months
- Healthy volunteers
- Accepted
Summary
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ followed by Havrix™ one month later.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Havrix® | 2 doses administered intramuscularly |
| BIOLOGICAL | M-M-R®II | 1 dose administered subcutaneously |
| BIOLOGICAL | VARIVAX® | 1 dose administered subcutaneously |
Timeline
- Start date
- 2003-10-06
- Primary completion
- 2009-06-09
- Completion
- 2009-06-09
- First posted
- 2005-09-20
- Last updated
- 2018-07-31
- Results posted
- 2010-04-01
Locations
42 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00197015. Inclusion in this directory is not an endorsement.