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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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ClinicalTrials.gov Identifier: NCT02697474
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Euvax B®: Hepatitis B vaccine Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Hexaxim® Group
Subjects that received Hexaxim® in Study A3L12
 Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Name: Euvax B®
Experimental: Infanrix® hexa Group
Subjects that received Infanrix® hexa in Study A3L12
 Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Name: Euvax B®


Outcome Measures
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Primary Outcome Measures :
  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 (pre-vaccination) ]
  2. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697474


Locations
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Thailand
Bangkok, Thailand
Khon Kaen, Thailand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02697474    
Other Study ID Numbers: A3L49
U1111-1161-2421 ( Other Identifier: WHO )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Individual participant data (IPD) and supporting clinical documents are available for request at http://www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI).

Details on Data Sharing criteria and process for requesting access can be found at this web address: http://www.Clinicalstudydatarequest.com/Sanofi"
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Hepatitis B
DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine
Euvax-B®
Hexaxim®
Infanrix® hexa
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs