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Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
This study is ongoing, but not recruiting participants.
Sponsored by: Shantha Biotechnics Limited
Information provided by: Shantha Biotechnics Limited
ClinicalTrials.gov Identifier: NCT00617812
  Purpose

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 Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type B
Biological: Shan5
Phase IV

MedlinePlus related topics: Diphtheria Flu Hepatitis Hepatitis B Tetanus Whooping Cough
Drug Information available for: Tetanus Vaccine Hepatitis B Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Shantha Biotechnics Limited:

Primary Outcome Measures:
  • Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited and unsolicited local and systemic adverse events following vaccination [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Shan5: Experimental Biological: Shan5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

  Eligibility

Ages Eligible for Study:   6 Weeks to 8 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617812

Locations
India, Andhra Pradesh
Deccan College of Medical Sciences
Hyderabaad, Andhra Pradesh, India, 500058
India, Gujrat
Ankur Institute of Child Health
Ahmedabad, Gujrat, India, 380009
India, Karnataka
JSS Medical College
Mysore, Karnataka, India, 570015
India, West Bengal
Institute of Child Health
Kolkata, West Bengal, India, 700017
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
Study Director: Raman Rao, MD Shantha Biotechnics Limited, Hyderabad, India
  More Information

Responsible Party: Shantha Biotechnics Limited ( Head Clinical Research and Medical Affairs )
Study ID Numbers: SBL/DTPwHB-Hib/PMS/2007/0100
Study First Received: February 6, 2008
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00617812  
Health Authority: India: Drugs Controller General of India

Keywords provided by Shantha Biotechnics Limited:
Vaccine
Prevention
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus influenzae type b
Healthy infants

Study placed in the following topic categories:
Bacterial Infections
Liver Diseases
Haemophilus influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Healthy
Orthomyxoviridae Infections
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepatitis B
Influenza, Human
DNA Virus Infections
Clostridium Infections

Additional relevant MeSH terms:
Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009