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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 Purpose

Hepatitis B

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis B focused on measuring Hepatitis B, Hexaxim®, Hexyon®, Hexacima®, Prevnar®, DTaP-IPV-HB-Hib hexavalent vaccine

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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

Toddlers vaccinated with Infanrix hexa® in study A3L12

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 18, 2015
Last Updated
March 19, 2018
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT02610348
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B, Hexaxim®, Hexyon®, Hexacima®, Prevnar®, DTaP-IPV-HB-Hib hexavalent vaccine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12
Arm Title
Group B
Arm Type
Experimental
Arm Description
Toddlers vaccinated with Infanrix hexa® in study A3L12
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
Intervention Description
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
Intervention Type
Biological
Intervention Name(s)
DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Intervention Description
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
Primary Outcome Measure Information:
Title
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
Description
Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur SA
Official's Role
Study Director
Facility Information:
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
29333947
Citation
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.
Results Reference
result

Learn more about this trial

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

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