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

Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278433

Enrollment

5007

Registered

2011-01-17

Start date

2010-12-31

Completion date

2012-06-30

Last updated

2013-03-29

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

Conditions

Polio, Poliomyelitis

Keywords

Polio, Poliovirus, IMOVAX Polio™

Brief summary

The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China. Objective: To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.

Detailed description

Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.

Interventions

BIOLOGICALIMOVAX Polio™: Inactivated Poliomyelitis Vaccine

0.5 mL, Intramuscular

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Days to 89 Days

Healthy volunteers

Yes

Inclusion criteria

* Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine. * 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; * Informed consent form obtained by the subject's parent/legal representative. * Subject plan to live in the selected study sites for at least three months after inclusion.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.	Up to 30 days after each vaccination	A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.

Countries

China

Outcome results

None listed

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