FindTrial
Sign In

Immunogenic response in children with hemophilia to Hepatitis B vaccine administered by subcutaneous versus intradermal route.

Immunogenicity of Hepatitis B vaccine administered by subcutaneous versus intradermal route in children with hemophilia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022528
Enrollment
50
Registered
2019-12-27
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

Health Condition 1: D67- Hereditary factor IX deficiency Health Condition 2: D66- Hereditary factor VIII deficiency

Interventions

Intervention1: Immunogenicity of Hepatitis B vaccine given intradermal: Recombinent Hepatitis B booster vaccine 2mcg will be given by intradermal route. Control Intervention1: immunogenicity of hepat

Sponsors

University College of Medical Sciences and Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Evidence of Hepatitis B vaccination (documentary / recall) Anti HBs antibody titres less than 10 mIU/ml will be included

Exclusion criteria

Exclusion criteria: Immunocompromised condition like HIV or individuals on steroids Known case of chronic liver disease or chronic kidney disease Hepatitis B surface antigen postitive Hepatitis B core antigen postitive (IgG)

Design outcomes

Primary

MeasureTime frame
Proportion of seroprotective individuals that is anti HBs titres more than 10 mIU per ml in both the groups at 1 month n 7 month of booster vaccinationTimepoint: 1 month n 7 months of booster vaccination—

Secondary

MeasureTime frame
Level of anti HBs antibody titres at 1 month and 7 months of booster vaccination.Timepoint: 1 month and 7 months of vaccination;Proportion of individuals with severe local reaction like local hematoma, scarring ,nodule, pain, itching or systemic reactions like anaphylaxis.Timepoint: within 7 months of vaccination—

Countries

India

Contacts

Public ContactDr Sunil Gomber

University College Of Medical Sciences GTB hospital New Delhi

sunilgomber@hotmail.com098106545664

Outcome results

None listed

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