Clinical trial NCT01333813: Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: immune response
Engerix-B™Kinder
Persistence
challenge dose
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
timeFrame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Secondary outcomes:
measure: Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.
timeFrame: Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
measure: 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
timeFrame: Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
measure: Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values
timeFrame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
measure: Anti-HBs Antibody Concentrations
timeFrame: One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
measure: Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose
timeFrame: After Engerix-B Kinder challenge dose (Month 1)
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)
Other outcomes:
Locations:
city: Bad Saulgau
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberstenfeld
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bindlach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kempten
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Braunatal
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: