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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00348387 |
This study is intended to support the registration of IMOVAX Polio in China.
The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
Condition | Intervention | Phase |
---|---|---|
Poliomyelitis Polio |
Biological: Poliomyelitis Vaccine inactivated Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 600 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Poliomyelitis Vaccine inactivated
0.5 mL, Intramuscular
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2: Active Comparator |
Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
1g dragee, oral
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Ages Eligible for Study: | 60 Days to 70 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
China, Guangxi Province | |
PingLe county, Guangxi Province, China, 542400 | |
Guilin City,, Guangxi Province, China, 541001 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur ( Medical Director ) |
Study ID Numbers: | IPV13 |
Study First Received: | July 3, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00348387 |
Health Authority: | China: State Food and Drug Administration |
Imovax polio poliomyelitis |
Virus Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Infections Poliomyelitis Central Nervous System Diseases |
Picornaviridae Infections Myelitis Degenerative motor system disease Enterovirus Infections Motor neuron disease Motor Neuron Disease |
RNA Virus Infections Nervous System Diseases Central Nervous System Viral Diseases |