Safety of Imovax Polio in Chinese Infants and Children

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00258843

Enrollment

Registered

2005-11-28

Start date

2005-11-30

Completion date

2006-04-30

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poliomyelitis

Keywords

IMOVAX;, poliomyelitis

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.

Interventions

BIOLOGICALInactivated Poliomyelitis vaccine

0.5 mL, intramuscular (IM)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Months to 18 Months

Healthy volunteers

Yes

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026