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

An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00693186

Enrollment

410

Registered

2008-06-06

Start date

2008-10-31

Completion date

2010-03-31

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief summary

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.

Interventions

BIOLOGICALHBVaxPRO® 5 µg / 0.5 mL

5 µg / 0.5 mL

BIOLOGICALEngerix B® 10 µg / 0.5 mL

10 µg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 7 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose	28 to 42 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026