NCT01890759

Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 17 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: * To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: * To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. * To assess the safety profile of Menactra® after each and any vaccination.

Detailed description

Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity. The planned duration of each subject's participation in the trial will be from 118 to 215 days.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Diphtheria Toxoid Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2013-06-25
• Primary completion: 2016-04-12
• Completion: 2016-04-12
• First posted: 2013-07-02
• Last updated: 2022-04-19
• Results posted: 2017-08-21

Locations

8 sites across 2 countries: India, Russia

Regulatory

• FDA-regulated drug study