NCT01470287

Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age

A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 42 Days – 64 Days
• Healthy volunteers: Accepted

Summary

This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Hemophilus Influenzae B

Interventions

Type	Name	Description
BIOLOGICAL	DTwP-HepB-Hib Vaccine	Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-11-11
• Last updated: 2017-05-19

Locations

3 sites across 1 country: India