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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00422292 |
Purpose
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.
Primary Objectives:
Observational Objectives:
Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.
Immunogenicity:
- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Meningitis Measles Mumps Rubella Varicella |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine Biological: Measles, Mumps, Rubella and Varicella |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers |
| Enrollment: | 1664 |
| Study Start Date: | December 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Menactra® at 9 and 12 Months
Participants will received Menactra® vaccination at 9 and 12 months of age.
|
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, intramuscular (IM)
Other Name: Menactra®
|
|
Experimental: Menactra® at 9 Months and Menactra® + MMRV at 12 Months
Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
|
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
Other Name: Menactra®
|
|
Experimental: Menactra® at 9 Months and Menactra® + PCV at 12 Months
Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
|
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
Other Name: Menactra®
|
|
Active Comparator: MMRV + PCV at 12 Months
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
|
Biological: Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC
Other Names:
|
No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.
At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.
Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group
Eligibility| Ages Eligible for Study: | 9 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contacts and Locations
Show 88 Study Locations| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
| Responsible Party: | Medical Monitor, Sanofi Pasteur, Inc |
| ClinicalTrials.gov Identifier: | NCT00422292 History of Changes |
| Other Study ID Numbers: | MTA37 |
| Study First Received: | January 12, 2007 |
| Results First Received: | May 10, 2011 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Menactra vaccine Meningococcal meningitis Measles Mumps |
Rubella Varicella vaccines Haemophilus influenzae type b Pneumococcal conjugate vaccine |
|
Chickenpox Herpes Zoster Measles Meningitis Meningitis, Meningococcal Mumps Rubella Herpesviridae Infections DNA Virus Infections Virus Diseases Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Central Nervous System Infections |
Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial Central Nervous System Bacterial Infections Bacterial Infections Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Rubulavirus Infections Parotitis Parotid Diseases Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Rubivirus Infections |