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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hexaxim® Group

Subjects that received Hexaxim® in Study A3L12

Group Type EXPERIMENTAL

Euvax B®: Hepatitis B vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Infanrix® hexa Group

Subjects that received Infanrix® hexa in Study A3L12

Group Type EXPERIMENTAL

Euvax B®: Hepatitis B vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Euvax B®: Hepatitis B vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Euvax B®: Hepatitis B vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Euvax B® Euvax B®

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes