NCT02640404

Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam

Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects Aged 9 Months to 55 Years in Vietnam

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults Objective: * To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.

Detailed description

Infants and toddlers will receive 2 doses of vaccine 3 months apart. Children ≥ 2 years through adults aged 55 years will receive 1 dose of vaccine. All participants will be evaluated for safety up to 28 days post-vaccination.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, Intramuscular. 2 doses 3 months apart
BIOLOGICAL	Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, Intramuscular.

Timeline

• Start date: 2016-06-06
• Primary completion: 2016-12-05
• Completion: 2016-12-05
• First posted: 2015-12-29
• Last updated: 2018-01-08
• Results posted: 2018-01-08

Locations

1 site across 1 country: Vietnam

Regulatory

• FDA-regulated drug study