Study to Describe Persistence of Hepatitis B Antibodies in Children Vaccinated with a Hexavalent Vaccine and to Evaluate Their Immune Memory Following a Vaccination with Hepatitis B Vaccine

Phase 1

• Conditions: challenge dose of Engerix B to assess the quality of the persisting immune memory against hepatitis B in children aged 6 to 7 years; MedDRA version: 20.0 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-004069-29-FI
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 487

Inclusion Criteria

Aged 6 to 7 years on the day of vaccination (6 to 7 years means from the day of the 6th birthday to the day before the 8th birthday).
-Informed Consent Form (ICF) has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed by the subject able to read.
-Receipt of 3 doses of either Hexyon or Infanrix hexa vaccine at the age of 3, 5, and 11 to 12 months in Study A3L38 with a post-dose 3 anti-hepatitis B (HB)s antibody titer available.

Are the trial subjects under 18? yes
Number of subjects for this age range: 487
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

-Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
-Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination except for influenza vaccination, which may be received less than 4 weeks before study vaccine.
-Subject known to have received HB containing vaccine after completion of Study A3L38 procedures.
-Receipt of immune globulins, blood or blood-derived products in the past 3 months.
-Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
-History or diagnosis of an of HB infection, confirmed either clinically, serologically, or microbiologically after completion of Study A3L38 procedures.
-Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
-Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
-Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
-Some criteria are temporarily exclusion criteria. In case a subject meets any of these criteria, a further appointment will be scheduled to reassess the subject’s eligibility.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified