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A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

NCT01177722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1375

Last updated 2014-05-05

Study results available
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Summary

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.

Primary Objectives:

* To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
* To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.

Secondary Objectives:

* To describe in each group the immunogenicity parameters for all antigens for each vaccine
* To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Conditions

Interventions

BIOLOGICAL

DTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-Hep B-IPV vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Days
Max Age
65 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • Colombia
  • Costa Rica

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 NCT01177722 on ClinicalTrials.gov