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Safety of Imovax Polio in Chinese Infants and Children

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Inactivated Poliomyelitis vaccine
Inactivated Poliomyelitis vaccine
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;, poliomyelitis

Eligibility Criteria

2 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Group 1: Aged 18 months (18-20 months) on the day of inclusion Group 2: Aged 2 months (56-70 days) on the day of inclusion Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2) Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2) Vaccination planned in the 4 weeks following the trial vaccination Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Children at 18 months of age

Infants at 2 months of age

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
January 20, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00258843
Brief Title
Safety of Imovax Polio in Chinese Infants and Children
Official Title
Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
IMOVAX;, poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Children at 18 months of age
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Infants at 2 months of age
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis vaccine
Other Intervention Name(s)
IMOVAX Polio™ (IPV)
Intervention Description
0.5 mL, intramuscular (IM)
Intervention Type
Biological
Intervention Name(s)
Inactivated Poliomyelitis vaccine
Other Intervention Name(s)
IMOVAX Polio ™ (IPV)
Intervention Description
0.5 mL, IM

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Group 1: Aged 18 months (18-20 months) on the day of inclusion Group 2: Aged 2 months (56-70 days) on the day of inclusion Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2) Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2) Vaccination planned in the 4 weeks following the trial vaccination Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Pingle
Country
China

12. IPD Sharing Statement

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

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Safety of Imovax Polio in Chinese Infants and Children

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