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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01470287
First received: November 9, 2011
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Diphtheria,
Tetanus,
Pertussis,
Hepatitis B,
Hemophilus Influenzae B
Biological: DTwP-HepB-Hib Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Seroprotection rate one month after the last dose of vaccine administration [ Time Frame: One month after last vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroprotection rate and GMCs one month after the last vaccine administration [ Time Frame: One month after last vaccination ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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.

  Eligibility

Ages Eligible for Study:   42 Days to 64 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470287

Locations
India
Rajarajeshwari Medical College and Hospital
Bangalore, Karnataka, India
Bharathi Vidyapeeth University
Pune, Maharashtra, India
Medical College Kolkata
Kolkatta, West Bengal, India
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01470287     History of Changes
Other Study ID Numbers: V66_05
Study First Received: November 9, 2011
Last Updated: April 30, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Novartis:
Infants,
Immunogenicity,
Safety

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Clostridium Infections

ClinicalTrials.gov processed this record on August 20, 2014