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Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
This study is currently recruiting participants.
Verified by Shantha Biotechnics Limited, April 2009
First Received: April 6, 2009   Last Updated: May 5, 2009   History of Changes
Sponsored by: Shantha Biotechnics Limited
Information provided by: Shantha Biotechnics Limited
ClinicalTrials.gov Identifier: NCT00877357
  Purpose

A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type B
Biological: Shan 5
Phase IV

MedlinePlus related topics: Diphtheria Flu Hepatitis Hepatitis B Tetanus Whooping Cough
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants

Further study details as provided by Shantha Biotechnics Limited:

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

Secondary Outcome Measures:
  • Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: January 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Shan 5 Lot No 1: Experimental Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Shan 5 Lot No 2: Experimental Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Shan 5 Lot No 3: Experimental Biological: Shan 5
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 (hepatitis B surface antigen) assured negative.
  • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.

Exclusion Criteria:

  • Administration of immunoglobulin or any blood products since birth.
  • Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination 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 or Hib.
  • 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 born to mothers known to be HIV positive.
  • 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 40.40C, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877357

Contacts
Contact: Mandeep S Dhingra, MD +91-40-66301000 ext 1801 drmandeep@shanthabiotech.co.in

Locations
India, UT
School of Public Health, Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, UT, India, 160012
Contact: Madhu Gupta, MD     +91-172-2755223     madhugupta21@gmail.com    
Principal Investigator: Madhu Gupta, MD            
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
Study Director: Raman Rao, MD Shantha Biotechnics Limited
  More Information

No publications provided

Responsible Party: Shantha Biotechnics Limited ( VP, Scientific and Medical Affairs )
Study ID Numbers: SBL/DTPwHBHib/WHOCON/2008/0100
Study First Received: April 6, 2009
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00877357     History of Changes
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
Lot Consistency
Long Term Immunogenicity
Reactogenicity
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
Gram-Negative Bacterial Infections
Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Influenza, Human
Hepatitis B
DNA Virus Infections
Clostridium Infections

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

ClinicalTrials.gov processed this record on May 07, 2009