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

Phase 3

Completed

• Conditions: Poliomyelitis; Polio
• Interventions: Biological: Poliomyelitis Vaccine inactivated; Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)

• Registration Number: NCT00348387
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-03
• Study First Posted: 2006-07-04
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Poliomyelitis Vaccine inactivated	-
Group 2	Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine	1 month post-vaccination 3

Secondary Outcome Measures

Name	Time	Method
To provide information concerning the safety of IMOVAX Polio™ vaccine	Entire study period