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NCT00422292 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,664
- Enrollment target
NCT00422292 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,664 participants.
The verdict
NCT00422292, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,664 participants
- Enrollment target
Study Summary
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: * To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. * To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. 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.
Interventions
- BIOLOGICAL Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
- BIOLOGICAL Measles, Mumps, Rubella and Varicella
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,664 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422292
The ClinicalTrials.gov registry entry for NCT00422292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,664 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Meningococcal Polysaccharide Diphtheria Conjugate Vaccine is the first listed.
NCT00422292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00422292 about?
NCT00422292 is a clinical study titled "Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers". This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: * To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with ...
What is the current status of trial NCT00422292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,664 participants. The study started on 2006-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00422292?
The interventions under investigation include: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine (BIOLOGICAL), Measles, Mumps, Rubella and Varicella (BIOLOGICAL).
Who is sponsoring clinical trial NCT00422292?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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