Safety of Imovax Polio in Chinese Infants and Children

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.

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Key information

Conditions

Poliomyelitis Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

2 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pingle, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inactivated Poliomyelitis vaccine

Biological

0.5 mL, intramuscular (IM)

Other names: IMOVAX Polio™ (IPV)

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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.

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Nov 28, 2005
Registry last updated: Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed