Status:
COMPLETED
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
Lead Sponsor:
Novartis Vaccines
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
42-64 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Male and female subjects ≥ 42 days to ≤ 64 days of age.
- Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements
Exclusion
- Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
- History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
- History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
- Administration of parenteral immunoglobulin preparation and/or blood products since birth.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01470287
Start Date
December 1 2011
End Date
April 1 2012
Last Update
May 19 2017
Active Locations (3)
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1
Rajarajeshwari Medical College and Hospital
Bangalore, Karnataka, India
2
Bharathi Vidyapeeth University
Pune, Maharashtra, India
3
Medical College Kolkata
Kolkata, West Bengal, India