Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02409095
Status:
TERMINATED
Last Update Posted:
2018-09-11
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants
Sponsor:
Serum Institute of India Pvt. Ltd.
Organization:
Study Overview
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 Vaccination By Needle And Syringe In Healthy Infants In India
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to increased rate of local injection site reactions in the DSJI group.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: