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.

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.