Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV

January 20, 2014 updated by: Sanofi Pasteur, a Sanofi Company

This study is intended to support the registration of IMOVAX Polio in China.

The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guilin City,, China, 541001
      • PingLe county, China, 542400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 2 months (60-70 days) on the day of inclusion into the study
  • Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more
  • Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
  • Able to attend all planned clinic appointment and obey and follow all study instructions

Exclusion Criteria:

  • Taking part in another clinical trial during the 4 weeks before the first trial vaccination
  • Have plans to take part in another clinical trial d during this trial period
  • Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
  • Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
  • Prolonged or long time illness that could interfere with study or full participation
  • Received blood or blood-derived products since birth
  • Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
  • Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
  • Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
  • History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
  • Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)
  • Bleeding disorder or a low platelet which do not allow vaccination into the muscle
  • Had seizures in the past
  • Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 2
Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
1g dragee, oral
Other Names:
  • Poliomyelitis Vaccine in Dragee Candy
Experimental: Group 1
Biological: Poliomyelitis Vaccine inactivated
0.5 mL, Intramuscular
Other Names:
  • IMOVAX Polio ™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
Time Frame: 1 month post-vaccination 3
1 month post-vaccination 3

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety of IMOVAX Polio™ vaccine
Time Frame: Entire study period
Entire study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPV13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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