At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 103 enrolled

Drug / intervention

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate +1 morebiological

Likely dose

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 0.5 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00771849

NCT00771849Phase 2Completed

Compare CT.gov

Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Children Who Have Previously Received a Monovalent Meningococcal C Conjugate Vaccine

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 15, 2008·Updated Apr 14, 2016

In Brief

A Phase 2 clinical trial evaluating Meningococcal Polysaccharide Diphtheria Toxoid Conjugate and Haemophilus Influenzae Type b (Hib) vaccine for Meningitis and Meningococcemia. Completed, enrolled 103 participants across 2 sites.

Detailed Summary

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously. Primary objective: To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMeningitis, Meningococcemia

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2003

Primary CompletionMar 2004

Study CompletionMay 2004

First PostedOct 2008

TodayJul 2026

First PostedOct 15, 2008

Enrollment StartAug 1, 2003

Primary CompletionMar 1, 2004

Study CompletionMay 1, 2004

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 17.7 years ago

Interventions

Meningococcal Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular

Haemophilus Influenzae Type b (Hib) vaccinebiological

0.5 mL, Intramuscular