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

March 19, 2018 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
      • Khon Kaen, Thailand, 40002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12
Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
EXPERIMENTAL: Group B
Toddlers vaccinated with Infanrix hexa® in study A3L12
Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (ESTIMATE)

November 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3L47
  • U1111-1161-2649 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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