A clinical trial to study the optimal use of conjugate typhoid vaccine- Single dose vs two doses.

Phase 4

Completed

• Registration Number: CTRI/2010/091/003031
• Lead Sponsor: DR. Balaji Chinnasami,No.5, Adhilaxmi Flats, Balaji Street, Rajaji Nagar, Villivakkam, Chennai-49Phone- 9445482710e-mail: balajictriumphants@gmail.com

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Healthy children between 6mths-5yrs of age attending immunization clinic, dept. of paediatrics, SRM medical college & research institute.

Exclusion Criteria

(1) Children having history of documented typhoid fever (blood culture positive/serum Widal test titre >1:160).
(2) Children who have already received typhoid vaccine.
(3) Children who have received blood transfusion/immunoglobulins in the last 4 weeks.
(4) On prolonged steroid therapy (>4 weeks within last 8 weeks).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroconversion rate- percentage of post-vaccination seropositive number out of the total number of vaccinees.Timepoint: Group A- Serum samples taken at baseline and two months after each dose of vaccine.<br>Group B- Serum samples taken at baseline and two months after one dose of vaccine.

Secondary Outcome Measures

Name	Time	Method
1.To assess the persistence of seroprotective levels of IgG anti-vi antibodies after one year of vaccination with conjugate typhoid vaccine (Peda Typh) in children upto five years. <br/ ><br>2. To compare the immunological persistence between single dose and double dose of conjugate vaccine. <br/ ><br>Timepoint: Follow up study will be conducted in the dept. of pediatrics, SRM medical college from March 2013 to June 2013.;Age related variations in seroresponse to vaccine.Timepoint: Group A- Baseline and two months after second dose.<br>Group B- Baseline and two months after one dose of typhoid vaccine.