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Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

NCT00315055 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2014-09-12

Study results available
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Summary

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.

Immunogenicity

* To assess pre- and post-primary series
* To assess pre- and post-booster series.

Conditions

Interventions

BIOLOGICAL

DTaP-IPV-HB-PRP~T vaccine

0.5 mL, Intramuscular (IM)

BIOLOGICAL

DTaP-IPV//PRP~T combined

0.5 mL, IM

BIOLOGICAL

Hepatitis B vaccine

0.5 mL, IM

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Days
Max Age
71 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-07-31
Completion
2008-02-29

Countries

  • Turkey (Türkiye)

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 NCT00315055 on ClinicalTrials.gov