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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470287
• Other study ID #: V66_05
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2011
• Last updated: May 17, 2017
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 64 Days

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
India	Rajarajeshwari Medical College and Hospital	Bangalore	Karnataka
India	Medical College Kolkata	Kolkatta	West Bengal
India	Bharathi Vidyapeeth University	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection rate one month after the last dose of vaccine administration		One month after last vaccination
Secondary	Seroprotection rate and GMCs one month after the last vaccine administration		One month after last vaccination