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To study the protective titre of DPT vaccine in children with Congenital Heart Disease

Sero protection of DPT containing vaccine in congenital heart disease: A cross sectional study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/05/066592
Enrollment
35
Registered
2024-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: Q209- Congenital malformation of cardiacchambers and connections, unspecified

Interventions

Sponsors

Intramural Research Grant University College of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive children visiting the pediatric outpatient department and admitted patients from the Pediatrics ward will be assessed for eligibility criteria. i. Cases: Children (16-24 months) with echocardiographic confirmed congenital heart disease attending pediatric OPD or IPD and previously received 3 primary doses and at least 1 booster dose of DPT-containing vaccine. ii. Comparison group: Healthy Children (16-24 months) without congenital heart disease attending pediatric OPD or IPD and previously received 3 primary doses and at least 1 booster dose of DPT-containing vaccine.

Exclusion criteria

Exclusion criteria: 1 Children receiving prolonged steroid therapy more than 4 weeks in the past 3 months 2 History of administration of blood or immunoglobulin in the last 3 months 3 Known case of malignancy or primary immunodeficiency or infant of HIV positive mother 4 Children suffering from other chronic diseases example chronic liver disease or chronic renal disease or thalassemia

Design outcomes

Primary

MeasureTime frame
Primary: To compare the proportion of children having seroprotective antibody titers against diphtheria between cases and comparison group. Secondary: (i) To compare the proportion of children having seroprotective antibody titers against pertussis between cases and comparison group. (ii) To compare the proportion of children having seroprotective antibody titers against tetanus between cases and comparison group (iii) To compare antibody titers against Diphtheria, Pertussis and Tetanus between cases and comparison groupTimepoint: 4-6 weeks after receiving 3rd dose of DPT containing vaccine

Secondary

MeasureTime frame
(i) To compare the proportion of children having seroprotective antibody titers against pertussis between cases and comparison group. (ii) To compare the proportion of children having seroprotective antibody titers against tetanus between cases and comparison group (iii) To compare antibody titers against Diphtheria, Pertussis and Tetanus between cases and comparison groupTimepoint: 4-6 weeks after receiving 3rd dose of DPT containing vaccine

Countries

India

Contacts

Public ContactDr Sumaira Khalil

UCMS and GTBH

skhalil@ucms.ac.in9810424664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026