Status:
COMPLETED
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
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Hepatitis B
Eligibility:
All Genders
4-7 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00693186
Start Date
October 1 2008
End Date
March 1 2010
Last Update
September 11 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Unità Operativa Semplice di Epidemiologia (UOSE)
Quarto, Napoli, Italy
2
Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"
Latisana, Udine, Italy
3
Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
Modica, Italy, 97015
4
AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
Ragusa, Italy, 97100