Status:
COMPLETED
Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Polio
Poliomyelitis
Eligibility:
All Genders
2-2 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination. Primary objective: * To demonstrate the non-inferiority of...
Detailed Description
Study participants will be randomized to receive either 3 doses of a commercially available Oral Poliovirus Vaccine (OPV), or 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine IMOVA...
Eligibility Criteria
Inclusion
- Aged ≥2 months and less than 3 months on the day of first study vaccine administration
- Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- Informed consent form has been signed and dated by the parent or other legally acceptable representative
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except Diphtheria, Tetanus, acellular Pertussis vaccine \[DTaP\], Haemophilus Influenzae Type b \[Hib\] vaccine, bacille Calmette-Guerin vaccine \[BCG\] and Hepatitis B given at least 7 days before and after study vaccination)Previous vaccination against poliomyelitis with either the trial vaccine or another vaccine
- Receipt of immune globulins, blood or blood-derived products since birth
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- Congenital or acquired immunodeficiency in close contacts to the subjects
- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- At high risk for human immunodeficiency virus (HIV) infection during the trial
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Laboratory-confirmed or otherwise known thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- Any other contraindication as listed in the study vaccines' leaflets.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT01475539
Start Date
November 1 2011
End Date
November 1 2013
Last Update
January 12 2015
Active Locations (1)
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1
Nanning, Guangxi, China, 530028