A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

• Conditions: Poliomyelitis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005186-23-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 5007

Inclusion Criteria

1) Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
2) Subject's parent /legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio according to the schedule. one injection at 2, 3, 4 months old respectively;
3) Informed consent form obtained by the subject's parent/legal representative.
4) Subject plan to live in the selected study sites for at least three months after inclusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5007
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
2) Acute medical illness with or without fever within the last 72 hours.
3) Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
4) Participation in another clinical trial at the same time.
5) Contraindications to vaccination according to IMOVAX Polio™ leaflet.
6) Subject plan to leave the study sites for at least three months after inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To describe serious adverse events (SAEs) within 30 days after each dose of IMOVAX Polio administered to infants at 2, 3 and 4 months of age and lived in the study cities of China.;Secondary Objective: Not applicable;Primary end point(s): - Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination;Timepoint(s) of evaluation of this end point: Up to 30 days after each vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable