Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260312
Status:
COMPLETED
Last Update Posted:
2005-12-01
First Post:
2005-11-29
Brief Title:
Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals
Sponsor:
Pan American Health Organization
Organization:
Pan American Health Organization
Study Overview
Official Title:
Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
Status:
COMPLETED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued
Detailed Description:
After polio eradication access to live polioviruses will be highly restricted and oral poliovirus vaccine OPV use must be discontinued OPV-using countries must decide whether to switch to inactivated poliovirus vaccine IPV or stop polio vaccination Because only limited data are available on IPV immunogenicity in tropical developing countries we conducted a randomized controlled trial of IPV in Cuba The objectives of this study were to assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI schedule 61014 wks of age vs placebo A third arm was added to evaluate the immunogenicity of IPV administered at 2 and 4 months of age Antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm Target sample size was 100 children in each arm Mucosal intestinal immunity was measured indirectly through assessing poliovirus excretion in each group after a natural challenge of trivalent oral polio vaccine OPVrecieved by study participants through their participation in the annual OPV mass campaigns approximately 1 month after their last dose of vaccine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None