Safety of Imovax Polio in Chinese Infants and Children

Phase 3

Completed

• Conditions: Poliomyelitis
• Interventions: Biological: Inactivated Poliomyelitis vaccine

• Registration Number: NCT00258843
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-24
• Study First Submitted QC: 2005-11-24
• Study First Posted: 2005-11-28
• Primary Completion: 2006-02
• Study Completion: 2006-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	Inactivated Poliomyelitis vaccine	Infants at 2 months of age
Group 1	Inactivated Poliomyelitis vaccine	Children at 18 months of age