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Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

NCT01475539 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2015-01-12

No results posted yet for this study

Summary

The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination.

Primary objective:

* To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series.

Secondary objectives:

* To evaluate the safety profile of the investigational vaccines after each administration in each group.
* To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group.
* To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.

Conditions

Interventions

BIOLOGICAL

Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio

0.5 mL, Intramuscular + 1g dragee candy oral dose

BIOLOGICAL

Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio

0.5 mL, Intramuscular + 1g dragee candy oral dose

BIOLOGICAL

Live oral poliovirus type 1, 2 and 3

1g dragee candy, oral

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • China

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 NCT01475539 on ClinicalTrials.gov