Clinical trial NCT00693186: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 410
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
timeFrame: 28 to 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Quarto
country: Italy
facility: Unità Operativa Semplice di Epidemiologia (UOSE)
state: Napoli
city: Latisana
country: Italy
facility: Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"
state: Udine
city: Modica
country: Italy
facility: Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
city: Ragusa
country: Italy
facility: AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
city: Sassari
country: Italy
facility: Dipartimento di Prevenzione Servizio di Igiene Pubblica
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Zanetti A, Parlato A, Romano L, Desole MG, Ferrera G, Giurdanella F, Zuliani M, Richard P, Thomas S, Fiquet A. Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy. Vaccine. 2012 Aug 24;30(39):5770-5. doi: 10.1016/j.vaccine.2012.06.078. Epub 2012 Jul 9.