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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

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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

Tracking Information
First Submitted Date  ICMJE February 6, 2008
First Posted Date  ICMJE February 18, 2008
Last Update Posted Date June 25, 2009
Study Start Date  ICMJE March 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
Solicited and unsolicited local and systemic adverse events following vaccination [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type B
Intervention  ICMJE Biological: Shan5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Study Arms  ICMJE Experimental: Shan5
Intervention: Biological: Shan5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2008)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 8 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00617812
Other Study ID Numbers  ICMJE SBL/DTPwHB-Hib/PMS/2007/0100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Head Clinical Research and Medical Affairs, Shantha Biotechnics Limited
Study Sponsor  ICMJE Shantha Biotechnics Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Raman Rao, MD Shantha Biotechnics Limited, Hyderabad, India
PRS Account Shantha Biotechnics Limited
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP