Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Engerix-B™ Kinder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333813

112688

Details and patient eligibility

About

This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.

Enrollment: 300 patients

Sex: All

Ages: 7 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• A male or female 7 to 8 years of age at the time of enrolment.
• Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
• Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment.
• In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Child in care
• Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
• History of or intercurrent hepatitis B disease.
• Hepatitis B vaccination at birth.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis B vaccine challenge dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease and/or fever at the time of enrolment.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Engerix-B Kinder Group

Experimental group

Description:

Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.

Treatment:

Biological: Engerix-B™ Kinder