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.

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02697474

Collaborator

(none)

150

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Biological: Euvax B®: Hepatitis B vaccine 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

Study Type:

Interventional

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 :

Feb 1, 2016

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hexaxim® Group Subjects that received Hexaxim® in Study A3L12	Biological: Euvax B®: Hepatitis B vaccine 0.5 mL, Intramuscular Other Names: 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 Names: Euvax B®

Arm

Intervention/Treatment

Experimental: Hexaxim® Group

Subjects that received Hexaxim® in Study A3L12

Biological: Euvax B®: Hepatitis B vaccine

0.5 mL, Intramuscular

Other Names:

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 Names:

Euvax B®

Outcome Measures

Primary Outcome Measures

Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study [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 [Day 28 (post-vaccination)]

Secondary Outcome Measures

Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study [Day 0 up to Day 28 post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.