NCT02610348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

November 18, 2015

Last Update Submit

March 19, 2018

Conditions

Hepatitis B

Keywords

Hepatitis BHexaxim®Hexyon®Hexacima®Prevnar®DTaP-IPV-HB-Hib hexavalent vaccine

Outcome Measures

Primary Outcomes (1)

  • Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study

    Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL

    Day 0

Study Arms (2)

Group A

EXPERIMENTAL

Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12

Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Group B

EXPERIMENTAL

Toddlers vaccinated with Infanrix hexa® in study A3L12

Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Interventions

DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccinesBIOLOGICAL

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

Group A
DTaP-HB-IPV and Pneumococcal polysaccharide vaccinesBIOLOGICAL

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

Group B

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, Da Costa X, Vidor E. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP approximately T vaccination at 2, 4 and 6 months. Hum Vaccin Immunother. 2018 May 4;14(5):1257-1265. doi: 10.1080/21645515.2018.1426418. Epub 2018 Feb 21.

    PMID: 29333947RESULT

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Medical Director

    Sanofi Pasteur SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

TH(2)