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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470287
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Hemophilus Influenzae B Biological: DTwP-HepB-Hib Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Seroprotection rate one month after the last dose of vaccine administration [ Time Frame: One month after last vaccination ]

Secondary Outcome Measures :
  1. Seroprotection rate and GMCs one month after the last vaccine administration [ Time Frame: One month after last vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   42 Days to 64 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470287


Locations
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01470287    
Other Study ID Numbers: V66_05
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Keywords provided by Novartis ( Novartis Vaccines ):
Infants,
Immunogenicity,
Safety
Additional relevant MeSH terms:
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Hepatitis B
Diphtheria
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bacterial Infections
Bacterial Infections and Mycoses
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections