NCT00772629

Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults

Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide (Serogroups A, C or Serogroups A, C, Y, and W-135) Vaccine or Not Vaccinated With Meningococcal Vaccine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years. Primary Objective: To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups. Secondary Objective: To collect reference sera for the development and refinement of laboratory assays for the measurement of antibody responses to serogroups Y and W 135.

Detailed description

Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study. There were no safety concerns involved in the decision to stop enrollment. Subjects that were enrolled at the time completed the study as per protocol, the last subject last visit was on 29 April 2004.

Conditions

• Meningitis
• Meningococcemia

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2008-10-15
• Last updated: 2014-02-14
• Results posted: 2009-04-27

Locations

2 sites across 1 country: United Kingdom