A clinical trial to Assess theImmunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine DTwP-Hib-HepB in Indian infants

Phase 3

Completed

• Conditions: Seroprotection against Diphtheria, Tetanus, Petussis, Hepatitis-B and Haemophilus Influenzae type B diseases.

• Registration Number: CTRI/2011/11/002118
• Lead Sponsor: Novartis Healthcare Pvt Ltd Vaccines Division

Brief Summary

This is a Phase III, single arm, multicentre, open label study to evaluate immunogenicity, safety and tolerability of 3 doses of a pentavalent vaccine administered to Indian infants at approximately 6, 10 and 14 weeks of age. The study will be conducted in 4 centers in India. DTwP-HepB-Hib is a fully liquid vaccine combining Diphtheria, Tetanus, whole cell Bordetella pertussis (B. pertussis), Hepatitis B (HepB), and Haemophilus influenzae type b (Hib) antigens. The primary immunogenicity objective of the study is to assess the seroprotective titers to diphtheria, tetanus, HepB, B.pertussis and  Hib one month after third study injection. Secondary Immunogenicity Objective is to evaluate geometric mean concentration (GMCs) against diphtheria, tetanus, B.pertussis, HepB and Hib antigens one month after third study injection,   The safety objective is to evaluate the safety and tolerability of Quinvaxem vaccine administered to infants at Days 1, 29 and 57 of the study.

7 Feb 2012: Study is not initiated at site 03, No Subjects recruited at this site.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-15
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

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

Inclusion Criteria

Healthy infants without any contradictions to receive investigational vaccine.

Exclusion Criteria

• 1.Parents unwilling or unable to provide written informed consent 2.
• History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
• 3.Known hypersensitivity or allergic reactions after previous vaccinations 4.Presence of any significant medical condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity Endpoints:	one month after the third study injection
Seroprotection rates one month after the last dose of vaccine administration	one month after the third study injection

Secondary Outcome Measures

Name	Time	Method
GMCs one month after last dose of vaccine administration	one month after the third study injection
Safety Endpoints:	Safety and Tolerability

Trial Locations

Locations (3)

Bharati Hospital and Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Medical College Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Rajarajeshwari Medical College & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Bharati Hospital and Research Center

🇮🇳Pune, MAHARASHTRA, India

Dr Sanjay Lalwani

Principal investigator

912024364308

sanjaylalwani2007@rediffmail.com