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OpenTrials
Completed

NCT Number: NCT02610348

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

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

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Biological

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

Primary outcomes

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

    Time frame: Day 0

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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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