Safety of Imovax Polio in Chinese Infants and Children - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258843

Purpose

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.

Condition	Intervention	Phase
Poliomyelitis	Biological: Inactivated Poliomyelitis vaccine	Phase III

MedlinePlus related topics: Polio and Post-Polio Syndrome

Drug Information available for: Poliovirus Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Further study details as provided by Sanofi-Aventis:

Enrollment:	40
Study Start Date:	November 2005
Study Completion Date:	April 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Children at 18 months of age	Biological: Inactivated Poliomyelitis vaccine 0.5 mL, IM
2: Experimental Infants at 2 months of age	Biological: Inactivated Poliomyelitis vaccine 0.5 mL, IM

Eligibility

Ages Eligible for Study:	2 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 HepB 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 HepB, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258843

Locations

China

Pingle, China

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur, Inc ( Medical Director )
Study ID Numbers:	IPV17
Study First Received:	November 24, 2005
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00258843
Health Authority:	China: State Food and Drug Administration

Keywords provided by Sanofi-Aventis:

IMOVAX;
poliomyelitis

Study placed in the following topic categories:

Virus Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Infections
Poliomyelitis
Central Nervous System Diseases

Picornaviridae Infections
Myelitis
Degenerative motor system disease
Enterovirus Infections
Motor neuron disease
Motor Neuron Disease

Additional relevant MeSH terms:

RNA Virus Infections
Nervous System Diseases
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on January 14, 2009