A Study of the Safety of IMOVAX Polio™ in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.

Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.

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Detailed Description

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Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.

Conditions

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Poliomyelitis Polio

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study Group

Group Type EXPERIMENTAL

IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

Intervention Type BIOLOGICAL

0.5 mL, at 2, 3, and 4 months; Intramuscular

Interventions

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IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

0.5 mL, at 2, 3, and 4 months; Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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IMOVAX POLIO™

Eligibility Criteria

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Inclusion Criteria

* Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
* Subject's parents/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 from 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 (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within the last 72 hours
* Subject plan to leave the study sites for at least three months after inclusion
* Administration of immune globulin or other blood products within the last three months
* Participation in another clinical trial at the same time
* Contraindication to vaccination according to IMOVAX Polio™ leaflet.

Minimum Eligible Age

60 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes