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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: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00422292 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,664 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentrat
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 |
What the finished NCT00422292 record still lists
NCT00422292 is an interventional study that assigns participants to a tested intervention. Its 1,664 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher).
The record links to 0 conditions, and to 2 interventions - of which Meningococcal Polysaccharide Diphtheria Conjugate Vaccine is the first listed.
NCT00422292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00422292's enrollment target sits among peer trials
1,664 137th of 2000 higher than 1,864 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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