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NCT00483574 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,378
- Enrollment target
NCT00483574: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00483574 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,378 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00483574, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,378 participants
- Enrollment target
Study Summary
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.
Primary Outcome
Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
Interventions
- BIOLOGICAL Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- BIOLOGICAL Measles-mumps-rubella-varicella vaccine
- BIOLOGICAL Routine paediatric vaccine - Pneumococcal conjugate (PCV)
- BIOLOGICAL Routine paediatric vaccine - Hepatitis A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,378 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00483574 record still lists
NCT00483574 is an interventional study that assigns participants to a tested intervention. Its 1,378 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 (78% higher).
The record links to 0 conditions, and to 4 interventions - of which Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate is the first listed.
NCT00483574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00483574 about?
NCT00483574 is a clinical study titled "Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers". This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two do...
What is the current status of trial NCT00483574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,378 participants. The study started on 2007-05. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00483574?
The interventions under investigation include: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (BIOLOGICAL), Measles-mumps-rubella-varicella vaccine (BIOLOGICAL), Routine paediatric vaccine - Pneumococcal conjugate (PCV) (BIOLOGICAL), Routine paediatric vaccine - Hepatitis A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00483574?
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 NCT00483574's enrollment target sits among peer trials
1,378 177th of 2000 higher than 1,824 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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