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Comparison of Hepatitis B surface Antibody levels after vaccination with combined one dose hexavalent-based vaccine (DTaP-IPV-HB-Hib) with two doses of pentavalent-based vaccine (DTwP-HB-Hib) versus three doses of pentavalent-based vaccine (DTwP-HB-Hib)

Comparison of Hepatitis B surface Antibody levels after vaccination with combined one dose hexavalent-based vaccine (DTaP-IPV-HB-Hib) with two doses of pentavalent-based vaccine (DTwP-HB-Hib) versus three doses of pentavalent-based vaccine (DTwP-HB-Hib)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240513002
Enrollment
80
Registered
2024-05-13
Start date
2022-05-24
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

The anti-HBs antibody levels after vaccination with combined one dose hexavalent-based vaccine (DTaP-IPV-HB-Hib) with two doses of pentavalent-based vaccine (DTwP-HB-Hib) versus three doses of pentavalent-based vaccine (DTwP-HB-Hib) at 3-6 months after the last dose of vaccination. HBV hepatitis B virus GMT geometric mean PCV pneumococcal conjugated vaccine

Interventions

Pentavalent group received the DTwP-HBV vaccine and an oral polio vaccine (OPV) at the age of 2 months. Received DTwP-HBV vaccine and IPV vaccine at the age of 4 months. Received DTwP-HBV vaccine at t
Pentavalent group,Combined hexavalent/pentavalent group

Sponsors

Research center, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Days to 120 Days

Inclusion criteria

Inclusion criteria: Infants who born at a gestational age more than 36 weeks Infants aged 30 to120 days who received a monovalent HBV vaccine at birth

Exclusion criteria

Exclusion criteria: Infants not born to HIV- or HBV-infected mothers and those with coagulopathy

Design outcomes

Primary

MeasureTime frame
Anti-HBs level 3-6 months after the last dose of vaccination Blood sampling for anti-HBs level

Secondary

MeasureTime frame
Compare adverse events 7 day after each vaccination Reported by phone for gathering information

Countries

Thailand

Contacts

Public ContactKantron Soonthornarrak

Faculty of Medicine Ramathibodi Hospital, Mahidol University

kantronsoon@gmail.com0854409568

Outcome results

None listed

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