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Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

NCT01444781 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1106

Last updated 2014-07-16

Study results available
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Summary

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are:

* To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose
* To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
* To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Conditions

Interventions

BIOLOGICAL

DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide

0.5 mL, Intramuscular each into the right and left deltoid muscle

BIOLOGICAL

DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide

0.5 mL, Intramuscular each into the right and left deltoid muscle

BIOLOGICAL

DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine

0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-04-30
Completion
2013-10-31

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 NCT01444781 on ClinicalTrials.gov