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

Phase 3

Completed

• Conditions: Tetanus; Pertussis; Diphtheria; Hepatitis B; Hemophilus Influenzae B
• Interventions: Biological: DTwP-HepB-Hib Vaccine

• Registration Number: NCT01470287
• Lead Sponsor: Novartis Vaccines

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Study Start: 2011-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. Male and female subjects ≥ 42 days to ≤ 64 days of age.
2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements

Exclusion Criteria

1. Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
3. History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
4. Administration of parenteral immunoglobulin preparation and/or blood products since birth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	DTwP-HepB-Hib Vaccine	-

Primary Outcome Measures

Name	Time	Method
Seroprotection rate one month after the last dose of vaccine administration	One month after last vaccination

Secondary Outcome Measures

Name	Time	Method
Seroprotection rate and GMCs one month after the last vaccine administration	One month after last vaccination

Trial Locations

Locations (3)

Rajarajeshwari Medical College and Hospital; 🇮🇳 Bangalore, Karnataka, India

Medical College Kolkata; 🇮🇳 Kolkatta, West Bengal, India

Bharathi Vidyapeeth University; 🇮🇳 Pune, Maharashtra, India