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Trial record 1 of 1 for:    NCT00617812
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Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

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: NCT00617812
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
Shantha Biotechnics Limited

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B Biological: Shan5 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Shan5 Biological: Shan5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Solicited and unsolicited local and systemic adverse events following vaccination [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children in the age group six to eight weeks
  • Born after a normal gestational period (36 - 42 weeks)
  • Mother's HBsAg assured negative.
  • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
  • Parents willing to fill the Diary Card

Exclusion Criteria:

  • Administration of immunoglobulin or any blood products since birth.
  • Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV & BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
  • Previous vaccination or evidence of infection with DTP.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
  • Major congenital or hereditary immunodeficiency.
  • Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
  • Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
  • Parent/s or guardian of subject unable to maintain diary card
  • Simultaneous participation in any other clinical study
Contacts and Locations
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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): NCT00617812


Locations
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India
Deccan College of Medical Sciences
Hyderabaad, Andhra Pradesh, India, 500058
Ankur Institute of Child Health
Ahmedabad, Gujrat, India, 380009
JSS Medical College
Mysore, Karnataka, India, 570015
Institute of Child Health
Kolkata, West Bengal, India, 700017
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
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Study Director: Raman Rao, MD Shantha Biotechnics Limited, Hyderabad, India
More Information
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Responsible Party: Head Clinical Research and Medical Affairs, Shantha Biotechnics Limited
ClinicalTrials.gov Identifier: NCT00617812    
Other Study ID Numbers: SBL/DTPwHB-Hib/PMS/2007/0100
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009
Keywords provided by Shantha Biotechnics Limited:
Vaccine
Prevention
Diphtheria
Tetanus
 Pertussis
Hepatitis B
Haemophilus influenzae type b
Healthy infants
Additional relevant MeSH terms:
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Hepatitis B
Whooping Cough
Tetanus
Diphtheria
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Respiratory Tract Infections
Respiratory Tract Diseases
 Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections