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Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

NCT00362427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2014-01-14

No results posted yet for this study

Summary

PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.

Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®

Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

Conditions

Interventions

BIOLOGICAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

0.5 mL, 4 doses, IM

BIOLOGICAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

0.5 Ml, 4 doses, IM

BIOLOGICAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

0.5 mL, 4 doses, IM with concommitant vaccines

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT00362427 on ClinicalTrials.gov