Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01579825
First received: April 16, 2012
Last updated: April 24, 2013
Last verified: April 2012

April 16, 2012
April 24, 2013
April 2012
December 2012   (final data collection date for primary outcome measure)
Serologic response [ Time Frame: 4 weeks after last dose of OPV ] [ Designated as safety issue: No ]
Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.
Same as current
Complete list of historical versions of study NCT01579825 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh
Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial

Hypothesis:

The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Polio
Other: Buffer
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.
  • Experimental: Buffer
    Intervention: Other: Buffer
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
up to 8 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01579825
IRB00003717
No
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
World Health Organization
Principal Investigator: Neal A Halsey, MD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP