Immunogenicity of hepatitis B vaccine in preterm infants: a randomized controlled trial of weight-based versus age-based regimens

Phase 3

• Conditions: ELBW preterm infantsVLBW preterm infants; ELBW preterm infants; VLBW preterm infants; Preterm; immunogenicity; HBV vaccine; weight- based; age&#45

• Registration Number: TCTR20200328002
• Lead Sponsor: Faculty of Medicine, Ramathibodi hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-28
• Study Completion: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Preterm infants with birthweight less than 1250 grams
2. Born to HBsAg negative mothers
3. Parents agree and sign a consent form

Exclusion Criteria

Parents' refusal of research participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity of HB vaccine between two groups 1 month after the first dose and 1-3 months after the last dose Serum Anti HBs Ab titer by ELISA method

Secondary Outcome Measures

Name	Time	Method
Determine the factors (GA, BW, steroid use, APGAR, comorbidities) that affect the immunogenicity 1 month after the first dose and 1-3 months after the last dose Logistic regression analysis of each factor