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

NCT02409095 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2018-09-11

No results posted yet for this study

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.

Conditions

  • Immune Response to DTP-HB-Hib Vaccine

Interventions

BIOLOGICAL

DTP-HB-Hib vaccine

Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases.

DEVICE

Disposable Syringe Jet Injector (DSJI)

Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.

OTHER

Needle & Syringe

The conventional needle syringe that is routinely used for vaccination.

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-02-29
Completion
2016-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409095 on ClinicalTrials.gov