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

Primary Purpose

Poliomyelitis, Polio

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Poliomyelitis Vaccine inactivated
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Imovax polio, poliomyelitis

Eligibility Criteria

60 Days - 70 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine

Secondary Outcome Measures

To provide information concerning the safety of IMOVAX Polio™ vaccine

Full Information

First Posted
July 3, 2006
Last Updated
January 20, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00348387
Brief Title
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Polio
Keywords
Imovax polio, poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Poliomyelitis Vaccine inactivated
Other Intervention Name(s)
IMOVAX Polio ™
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
Other Intervention Name(s)
Poliomyelitis Vaccine in Dragee Candy
Intervention Description
1g dragee, oral
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
Time Frame
1 month post-vaccination 3
Secondary Outcome Measure Information:
Title
To provide information concerning the safety of IMOVAX Polio™ vaccine
Time Frame
Entire study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
70 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Guilin City,
ZIP/Postal Code
541001
Country
China
City
PingLe county
ZIP/Postal Code
542400
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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

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