EUCTR2015-005182-23-Outside-EU/EEA
Active, not recruiting
Not Applicable
Immunogenicity and Safety of the Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered at 2, 3, and 4 Months of Age and Followed by a Booster Dose at 18 Months of age in Healthy Infants in China, versus Commercially Available Oral Poliomyelitis Vaccine
Sanofi Pasteur SA0 sites600 target enrollmentNovember 17, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Poliomyelitis
- Sponsor
- Sanofi Pasteur SA
- Enrollment
- 600
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Aged 2 months (60\-70 days) on the day of inclusion into the study
- •\- Born at full term pregnancy ( over 36 weeks) with a birth weight \= 2\.5 kg 2Ibs) or more
- •\- Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
- •\- Able to attend all planned clinic appointment and obey and follow all study instructions
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 600
- •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
- •\- Taking part in another clinical trial during the 4 weeks before the first trial vaccination
- •\- Have plans to take part in another clinical trial d during this trial period
- •\- Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
- •\- Systemic reaction to any vaccine component or history of life\-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
- •\- Prolonged or long time illness that could interfere with study or full participation
- •\- Received blood or blood\-derived products since birth
- •\- Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
- •\- Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
- •\- Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
- •\- History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
Outcomes
Primary Outcomes
Not specified
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