Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age

Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02610348

Enrollment

122

Registered

2015-11-20

Start date

2015-11-30

Completion date

2016-03-31

Last updated

2018-03-20

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

Conditions

Hepatitis B

Keywords

Hepatitis B, Hexaxim®, Hexyon®, Hexacima®, Prevnar®, DTaP-IPV-HB-Hib hexavalent vaccine

Brief summary

Primary Objective: To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.

Detailed description

Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.

Interventions

BIOLOGICALDTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

BIOLOGICALDTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

* Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 & 6 months of age) * Subjects having participated in PNA19 * Subject's parents having given authorization to use serum collected in PNA19 for future research * The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases * Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level.

Exclusion criteria

* Not applicable.

Design outcomes

Primary

Measure	Time frame	Description
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study	Day 0	Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026