Safety of Imovax Polio in Chinese Infants and Children

Poliomyelitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258843
• Other study ID #: IPV17
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2005
• Last updated: January 20, 2014
• Start date: November 2005
• Est. completion date: April 2006

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 18 Months

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated Poliomyelitis vaccine
0.5 mL, intramuscular (IM)
• Inactivated Poliomyelitis vaccine
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

External Links

•   Link
•   Link