NCT01362517

Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 60 Days – 120 Days
• Healthy volunteers: Accepted

Summary

The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule

Conditions

• Diphtheria
• Pertussis
• Tetanus
• Hepatitis B
• Haemophilus Influenzae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Quinvaxem	A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-07-01
• Completion: 2011-04-01
• First posted: 2011-05-30
• Last updated: 2013-09-09
• Results posted: 2013-06-24

Locations

1 site across 1 country: Vietnam