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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

NCT01948193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2015-10-20

Study results available
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Summary

The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT\~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India.

Primary Objective:

* To evaluate the immunogenicity of the study vaccine in terms of seroprotection \[diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)\] and vaccine response for pertussis antigens \[pertussis toxoid (PT) and filamentous haemagglutinin (FHA)\] one month after the third dose.

Secondary Objectives:

* To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose.
* To describe the safety after each and any doses of the study vaccine.

Conditions

Interventions

BIOLOGICAL

Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT01948193 on ClinicalTrials.gov