Trial record 16 of 21 for:    Open Studies | "Hypocalcemia"

Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Shantha Biotechnics Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shantha Biotechnics Limited
ClinicalTrials.gov Identifier:
NCT00877357
First received: April 6, 2009
Last updated: May 5, 2009
Last verified: April 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Experimental: Shan 5 Lot No 1 Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Experimental: Shan 5 Lot No 2 Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Experimental: Shan 5 Lot No 3 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: VP, Scientific and Medical Affairs, Shantha Biotechnics Limited
ClinicalTrials.gov Identifier: NCT00877357     History of Changes
Other Study ID Numbers: SBL/DTPwHBHib/WHOCON/2008/0100
Study First Received: April 6, 2009
Last Updated: May 5, 2009
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

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

ClinicalTrials.gov processed this record on August 28, 2014