A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

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

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-03-31

Brief Summary

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Primary objective:

* To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .

Secondary objectives:

* Additional immunogenicity assessments
* Standard safety assessment.

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

HBVaxPRO® 5 µg / 0.5 mL

Intervention Type BIOLOGICAL

5 µg / 0.5 mL

2

Group Type EXPERIMENTAL

Engerix B® 10 µg / 0.5 mL

Intervention Type BIOLOGICAL

10 µg

Interventions

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HBVaxPRO® 5 µg / 0.5 mL

5 µg / 0.5 mL

Intervention Type BIOLOGICAL

Engerix B® 10 µg / 0.5 mL

10 µg

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy child of 4 to 7 years of age of either gender,
* Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
* Informed consent form signed by the parent(s) or by the legal representative.
* Parent(s) or legal representative able to understand and comply with the study procedures.

Exclusion Criteria

* Any recent (\<=3 days) history of febrile illness prior to vaccination,
* Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
* History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
* History or current close contact with known carriers of hepatitis B virus,
* Prior known sensitivity/allergy to any component of the study vaccines,
* Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Any immune impairment or humoral/cellular deficiency or depressed immunity,
* Any recent (\<=30 days) long-term (\>=14 days) administration of systemic corticosteroids given daily or on alternate days at \>=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
* Any receipt (\<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
* Any recent (\<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2,
* Any recent (\<=28 days) receipt of a live vaccine or scheduled administration through Visit 2

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes