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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Sanofi

Status and phase

Completed
Phase 3

Conditions

Hepatitis B

Treatments

Biological: Euvax B®: Hepatitis B vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02697474
U1111-1161-2421 (Other Identifier)
A3L49

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

9 to 10 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Hexaxim® Group
Experimental group
Description:
Subjects that received Hexaxim® in Study A3L12
Treatment:
Biological: Euvax B®: Hepatitis B vaccine
Infanrix® hexa Group
Experimental group
Description:
Subjects that received Infanrix® hexa in Study A3L12
Treatment:
Biological: Euvax B®: Hepatitis B vaccine

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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