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

Brief Title

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

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

Brief Summary

      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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Solicited and unsolicited local and systemic adverse events following vaccination

Secondary Outcome

 Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine

Condition

Diphtheria

Intervention

Shan 5

Study Arms / Comparison Groups

 Shan 5 Lot No 1

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

3000

Start Date

January 2009

Completion Date

February 2013

Primary Completion Date

December 2012

Eligibility 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
      

Gender

All

Ages

6 Weeks - 8 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Raman Rao, MD, +91-40-66301000, [email protected]

Location Countries

India

Location Countries

India

NCT ID

NCT00877357

Organization ID

SBL/DTPwHBHib/WHOCON/2008/0100

Study Sponsor

Shantha Biotechnics Limited

Study Sponsor

Raman Rao, MD, Study Director, Shantha Biotechnics Limited

Verification Date

April 2009