NCT01333813CompletedPhase 4
Long-term Antibody Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Previously Vaccinated With Infanrix Hexa Vaccine
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 300
- Locations
- 12
- Primary Endpoint
- Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Engerix-B Kinder Group
Experimental
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.
Intervention: Engerix-B™ Kinder (Biological)
Outcomes
Primary Outcomes
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
Time Frame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Secondary Outcomes
- Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.(Before (Day 0) a challenge dose of Engerix-B Kinder vaccine)
- Number of Subjects Reporting Any Unsolicited AEs(During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine)
- Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine(Before (Day 0) a challenge dose of Engerix-B Kinder vaccine)
- Anti-HBs Antibody Concentrations(One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine)
- Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose(After Engerix-B Kinder challenge dose (Month 1))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs(During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine)
- Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values(One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)(During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1))
Investigators
Study Sites (12)
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