Safety of Imovax Polio in Chinese Infants and Children

NCT ID: NCT00258843

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Poliomyelitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Children at 18 months of age

Group Type EXPERIMENTAL

Inactivated Poliomyelitis vaccine

Intervention Type BIOLOGICAL

0.5 mL, intramuscular (IM)

Group 2

Infants at 2 months of age

Group Type EXPERIMENTAL

Inactivated Poliomyelitis vaccine

Intervention Type BIOLOGICAL

0.5 mL, IM

Interventions

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Inactivated Poliomyelitis vaccine

0.5 mL, intramuscular (IM)

Intervention Type BIOLOGICAL

Inactivated Poliomyelitis vaccine

0.5 mL, IM

Intervention Type BIOLOGICAL

Other Intervention Names

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IMOVAX Polio™ (IPV) IMOVAX Polio ™ (IPV)

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

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Pingle, , China

Site Status

Countries

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China

Related Links

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Other Identifiers

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IPV17

Identifier Type: -

Identifier Source: org_study_id

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