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| Sponsor: | Novartis |
|---|---|
| Collaborator: |
Novartis Vaccines |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00626327 |
Purpose
Safety immune response of Novartis MenACWY conjugate vaccine when given to healthy toddlers
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Infections |
Biological: MenACWY and MMRV Biological: MMRV |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers |
| Estimated Enrollment: | 1830 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: MenACWY and MMRV
V1: MenACWY, V3: MenACWY plus MMRV vaccine at 9 and 12 months of age.
|
| 2: Experimental |
Biological: MenACWY and MMRV
V1: MenACWY, V3: MenACWY and V4: MMRV vaccine at 9, 12 and 13.5 months of age
|
| 3: Active Comparator |
Biological: MMRV
V3: MMRV at 12 months of age
|
Eligibility| Ages Eligible for Study: | 7 Months to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 89 Study Locations| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
| Responsible Party: | Novartis Vaccines ( Novartis ) |
| Study ID Numbers: | V59P21, BB-IND 11278 |
| Study First Received: | February 20, 2008 |
| Last Updated: | December 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00626327 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
vaccine toddlers healthy meningitis meningococcal |
measles mumps rubella varicella Prevention of Meningococcal disease types ACWY |
|
Bacterial Infections Meningococcal Infections Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |