Trials / Completed
CompletedNCT00474526
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,545 (actual)
- Sponsor
- Novartis Vaccines · Industry
- Sex
- All
- Age
- 2 Months – 2 Months
- Healthy volunteers
- Accepted
Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal ACWY Conjugate Vaccine | |
| BIOLOGICAL | DTaP-IPV-HBV | |
| BIOLOGICAL | Hib | |
| BIOLOGICAL | Rotavirus | |
| BIOLOGICAL | Pneumococcal 7-valent Conjugate Vaccine | |
| BIOLOGICAL | HAV | |
| BIOLOGICAL | MMR-V | |
| BIOLOGICAL | DTaP |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2008-09-01
- Completion
- 2009-11-01
- First posted
- 2007-05-17
- Last updated
- 2014-03-24
- Results posted
- 2014-03-24
Locations
63 sites across 3 countries: United States, Argentina, Colombia
Source: ClinicalTrials.gov record NCT00474526. Inclusion in this directory is not an endorsement.