Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh
|ClinicalTrials.gov Identifier: NCT01579825|
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : April 25, 2013
The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.
|Condition or disease||Intervention/treatment||Phase|
|Polio||Other: Buffer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
5 ml of oral buffer solution containing 64 mg of sodium bicarbonate plus 24 mg of sodium citrate. The buffer will be administered prior to each dose of OPV at 6, 10 and 14 weeks of age.
|No Intervention: Control|
- Serologic response [ Time Frame: 4 weeks after last dose of OPV ]Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579825
|Principal Investigator:||Neal A Halsey, MD||Johns Hopkins Bloomberg School of Public Health|