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 - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-005168-29-IT
• Date of registration: 11/02/2008
• Prospective Registration: Yes
• Primary sponsor: SANOFI PASTEUR MSD S.N.C
• Public 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 - ND
• Scientific 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 - ND
• Date of first enrolment: 13/08/2008
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005168-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Healthy child of either gender, 2. Child of 4 to 7 years of age (from the first day of the 4th birthday to one day prior to the 8th birthday) 3. Groups 1A and 1B: Child vaccinated with 2 doses of HEXAVAC during the first 6 months of life and with a 3rd dose of HEXAVAC during the second year of life (documented vaccination history), or Groups 2A and 2B: Child vaccinated with 2 doses of INFANRIX-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX-HEXA during the second year of life (documented vaccination history), 4. Informed consent form signed by the parent(s) or by the legal representative according to the local regulations. 5. Parent(s) or legal representative able to attend all scheduled visits with the subject and to understand and comply with the study procedures (i.e. able to read and write).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1- Any recent (equal or less than 3 days) history of febrile illness (rectal temperature equal or greater than 38.0C or oral temperature ≥37.5C), 2- Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination, 3- History of clinical or serological-confirmed diagnosis of infection due to hepatitis B, 4- History or current close contact with known carriers of hepatitis B virus, 5- Prior known sensitivity/allergy to any component of the study vaccines, 6- Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems, 7- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, 8- Any immune impairment or humoral/cellular deficiency or depressed immunity, 9- Any recent (eual or less than 30 days) long-term (equal or more than 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (more or qgual to 20mg/day) or scheduled administration through Visit 2, 10- Any receipt (eual or less than 3 months) of immune globulin or blood-derived product, or scheduled administration through Visit 2, 11- Any recent (equal or less than 14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2, 12- Any recent (equal or less than 28 days) receipt of a live vaccine or scheduled administration through Visit 2 13- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, 14- Subject that, in the investigator?s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements, 15- Planned participation in another clinical study during the present study period. Second part of the study only: Investigators are recommended to defer/reschedule vaccination if any of the following conditions is true: 1. Febrile illness (rectal temperature equal or greater than 38.0C or oral temperature ≥37.5C) within 3 days prior to vaccination, 2. Current immunosuppressive therapy (including systemic corticosteroids given daily or on alternate days at equal or more than 20 mg/day prednisone equivalent during 14 days or more in the previous 30 days) 3. Receipt of immunoglobulins or blood-derived products within the previous 3 months 4. Receipt of an inactivated vaccine within the previous 14 days 5. Receipt of a live vaccine within the past 28 days.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age
MedDRA version: 9.1 Level: LLT Classification code 10054130 Term: Hepatitis B immunisation

Intervention(s)

Trade Name: HBVAXPRO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: ENGERIX B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: Immunogenicity To describe in subjects vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX-HEXA during the two first years of life: - The percentage of subjects with anti-HBs antibody titres ≥100 mIU/mL at 1 month post-booster dose (4th dose of a Hepatitis B vaccine) of each of either HBVAXPRO 5 µg or ENGERIX-B 10 µg. - The anti-HBs antibody titres at each time-point. - The percentage of subjects with anti-HBs antibody titres ≥10 mIU/mL and ≥100 mIU/mL and the anti-HBs antibody titres at 1 month post-booster dose (4th dose of a Hepatitis B vaccine) of either HBVAXPRO 5 µg or ENGERIX-B 10 µg according to the pre-booster anti-HBs antibody titres. Safety To describe the safety profile of each of both HBVAXPRO 5 µg and ENGERIX-B 10 µg when administered as a booster dose (4th dose of a Hepatitis B vaccine

Main Objective: Immunogenicity 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 (i.e. seroprotection rate) 1 month after a booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO 5 μg or ENGERIX-B 10 μg.

Primary end point(s): This study is a descriptive study. The data will be summarised and no particular formal hypothesis will be tested.

Secondary ID(s)

HXV01C