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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200328002

Enrollment

Registered

2020-03-28

Start date

2020-03-20

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

ELBW preterm infants VLBW preterm infants ELBW preterm infants VLBW preterm infants Preterm immunogenicity HBV vaccine weight&#45

Interventions

Administer first dose of HBV vaccine at weight 1&#44

800&#45

2&#44

000 grams,Administer first dose of HBV vaccine at a month of age

Experimental Biological/Vaccine,Experimental Biological/Vaccine

Weight&#45

based group,Age&#45

based group

Eligibility

Sex/Gender

All

Age

No minimum to 2 Months

Inclusion criteria

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

Exclusion criteria: Parents' refusal of research participation

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactWarittha Supho

Faculty of medicine, Ramathibodi hospital, Mahidol university

dao_23@hotmail.com+66870324682

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Immunogenicity of hepatitis B vaccine in preterm infants: a randomized controlled trial of weight&#45;based versus age&#45;based regimens