MedTrace Logo

Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

NCT00604058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2014-01-22

No results posted yet for this study

Summary

The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Inactivated Poliomyelitis vaccine (IMOVAX)

Fractional dose (1/5th) 0.1 mL, intradermally

BIOLOGICAL

Inactivated Poliomyelitis vaccine (IMOVAX)

A full dose, 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
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • Philippines

Study Locations

More Related Trials

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 NCT00604058 on ClinicalTrials.gov