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

Immunogenicity of conjugated typhoid Vi vaccine in children ? Single dose Vs Two doses

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003031

Enrollment

400

Registered

2010-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Conjugate Typhoid Vaccination: Two doses at two months interval. Each dose=0.5ml Control Intervention1: Conjugate Typhoid vaccination: Single Dose Dose=0.5ml

Eligibility

Inclusion criteria

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

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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. Group B- Serum samples taken at baseline and two months after one dose of vaccine.	—

Secondary

Measure	Time frame
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. 2. To compare the immunological persistence between single dose and double dose of conjugate vaccine. 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. Group B- Baseline and two months after one dose of typhoid vaccine.	—

Measure

Time frame

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. 2. To compare the immunological persistence between single dose and double dose of conjugate vaccine. 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. Group B- Baseline and two months after one dose of typhoid vaccine.

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Countries

India

Contacts

Public ContactDr. Balaji Chinnasami

balajictriumphants@gmail.com04426507434

Outcome results