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NCT00777257 · ClinicalTrials.gov registry record · Phase 4

Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
1,345
Enrollment target

NCT00777257: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.

NCT00777257 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,345 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (160% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00777257, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
1,345 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Interventions

  • BIOLOGICAL T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
  • BIOLOGICAL Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
  • BIOLOGICAL Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap

Trial Details

FieldValue
Enrollment Target 1,345 participants
Start Date 2005-04
Est. Completion 2007-09
Phase Phase 4
Sanofi Pasteur, a Sanofi Company

153 total trials

What the finished NCT00777257 record still lists

NCT00777257 is an interventional study that assigns participants to a tested intervention. Its 1,345 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (160% higher).

The record links to 0 conditions, and to 3 interventions - of which T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. is the first listed.

NCT00777257 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00777257 about?

NCT00777257 is a clinical study titled "Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine". The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibo...

What is the current status of trial NCT00777257?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,345 participants. The study started on 2005-04. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00777257?

The interventions under investigation include: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (BIOLOGICAL), Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (BIOLOGICAL), Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap (BIOLOGICAL).

Who is sponsoring clinical trial NCT00777257?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00777257's enrollment target sits among peer trials

1,345 56th of 2000 higher than 1,945 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00777257, the US trial registry maintained by the National Library of Medicine. NCT00777257 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.