Polio, Poliomyelitis
Conditions
Keywords
Poliomyelitis, IMOVAX POLIO™, Polio
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALIMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. | Day 0 to Day 30 post-vaccination | Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability. |
Countries
China
Outcome results
None listed