Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Euvax B®: Hepatitis B vaccine
Euvax B®: Hepatitis B vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine, Euvax-B®, Hexaxim®, Infanrix® hexa
Eligibility Criteria
Inclusion Criteria:
- Informed consent form signed by subject's parent/legally acceptable representative
- Assent form signed by subject
- Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures
- Receipt of primary vaccination with 3 doses of either Hexaxim® or Infanrix® hexa at the age of 2, 4, and 6 months in the A3L12 study, and hepatitis B vaccine at birth.
Exclusion Criteria:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial
- Incomplete primary immunization in the A3L12 study
- Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures
- Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral polio vaccine [OPV] in the context of oral polio vaccine-national immunization days [OPV-NIDs] does not fall within the scope of this exclusion criterion)
- Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion
- Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures
- Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma [T or B cells], Crohn's disease)
- Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures
- Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hexaxim® Group
Infanrix® hexa Group
Arm Description
Subjects that received Hexaxim® in Study A3L12
Subjects that received 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 in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine
Secondary Outcome Measures
Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
Full Information
NCT ID
NCT02697474
First Posted
February 29, 2016
Last Updated
March 28, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT02697474
Brief Title
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
Official Title
Persistence of Anti-Hep B Antibodies at 9 to 10 Years of Age in Subjects Having Received Hep B Vaccine at Birth and a DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine at 2, 4 and 6 Months of Age, and Evaluation of Their Immune Memory Following a Challenge Re-vaccination With a Stand Alone Hep B Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 2017 (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
The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine.
Primary objectives:
To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2])
To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination).
Secondary objectives:
To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.
Detailed Description
Subjects age 9 to 10 years who had received 3 injections of Hexaxim® or Infanrix® hexa and have completed the A3L12 study will be invited to participate in this study. They will receive one dose of Euvax-B® vaccine at Day 0.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B, DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine, Euvax-B®, Hexaxim®, Infanrix® hexa
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hexaxim® Group
Arm Type
Experimental
Arm Description
Subjects that received Hexaxim® in Study A3L12
Arm Title
Infanrix® hexa Group
Arm Type
Experimental
Arm Description
Subjects that received Infanrix® hexa in Study A3L12
Intervention Type
Biological
Intervention Name(s)
Euvax B®: Hepatitis B vaccine
Other Intervention Name(s)
Euvax B®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Euvax B®: Hepatitis B vaccine
Other Intervention Name(s)
Euvax B®
Intervention Description
0.5 mL, Intramuscular
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
Time Frame
Day 0 (pre-vaccination)
Title
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine
Time Frame
Day 28 (post-vaccination)
Secondary Outcome Measure Information:
Title
Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
Time Frame
Day 0 up to Day 28 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Informed consent form signed by subject's parent/legally acceptable representative
Assent form signed by subject
Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures
Receipt of primary vaccination with 3 doses of either Hexaxim® or Infanrix® hexa at the age of 2, 4, and 6 months in the A3L12 study, and hepatitis B vaccine at birth.
Exclusion Criteria:
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial
Incomplete primary immunization in the A3L12 study
Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures
Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures
Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral polio vaccine [OPV] in the context of oral polio vaccine-national immunization days [OPV-NIDs] does not fall within the scope of this exclusion criterion)
Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion
Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures
Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma [T or B cells], Crohn's disease)
Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures
Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
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
Country
Thailand
City
Khon Kaen
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
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Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
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