Clinical Trial: Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To

Brief Summary:

This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment.

It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.


Detailed Summary: This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of Serum Institute of India Ltd. delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B (HBsAg) and Hemophilus Influenza B at 28 days after administration of a third dose of the vaccine.
Sponsor: Serum Institute of India Pvt. Ltd.

Current Primary Outcome: Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis [ Time Frame: one month after administration of third dose of the vaccine ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of solicited reactions [ Time Frame: within 4 days following the administration of each of the three vaccine dose ]
  • Occurrence of adverse event [ Time Frame: 84 days after first vccine dose ]
  • Occurrence of serious adverse event [ Time Frame: 84 days after first vccine dose ]


Original Secondary Outcome: Same as current

Information By: Serum Institute of India Pvt. Ltd.

Dates:
Date Received: January 12, 2015
Date Started: January 2015
Date Completion:
Last Updated: April 13, 2016
Last Verified: April 2016