Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh
Not Applicable
Completed
- Conditions
- Polio
- Interventions
- Other: Buffer
- Registration Number
- NCT01579825
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
Hypothesis:
The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.
- Detailed Description
The investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (OPV) in Bangladeshi infants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- infants who are 4-8 weeks old
- residents of study area
Exclusion Criteria
- received a blood transfusion or any other blood product (such as immune globulin)
- likely to move out of study area within the next four months
- currently enrolled or planning to enroll in another study
- major congenital malformations
- neurologic disorders
- immunodeficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Buffer Buffer -
- Primary Outcome Measures
Name Time Method Serologic response 4 weeks after last dose of OPV Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.
- Secondary Outcome Measures
Name Time Method