NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT00693186

CompletedPhase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Hepatitis B

Interventions: HBVaxPRO® 5 µg / 0.5 mL, Engerix B® 10 µg / 0.5 mL

Countries: Italy

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 overview

Sex: ALL

Age: 4 Years to 7 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (5)

Quarto, Napoli, Italy
Latisana, Udine, Italy
Modica, Italy
Ragusa, Italy
Sassari, Italy