Overview

This trial is active, not recruiting.

Condition hepatitis b
Treatments euvax b®: hepatitis b vaccine
Phase phase 3
Sponsor Sanofi Pasteur, a Sanofi Company
Start date February 2016
End date June 2016
Trial size 150 participants
Trial identifier NCT02697474, A3L49, U1111-1161-2421

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects that received Hexaxim® in Study A3L12
euvax b®: hepatitis b vaccine Euvax B®
0.5 mL, Intramuscular
(Experimental)
Subjects that received Infanrix® hexa in Study A3L12
euvax b®: hepatitis b vaccine Euvax B®
0.5 mL, Intramuscular

Primary Outcomes

Measure
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)
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 Outcomes

Measure
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

Male or female participants from 9 years up to 10 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Sanofi.