Hepatitis B Vaccine
Conditions
Keywords
Hepatitis B vaccine, Challenge dose
Brief summary
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALEngerix™-B Kinder
Intramuscular injection, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment. * With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany * Written informed consent obtained from the parents or guardians of the subject at the time of enrolment. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* 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 third dose of Engerix™-B vaccine. * 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 HBV vaccine challenge and ending 30 days after. * Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value | One month after the challenge dose of HBV vaccine | Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | Before challenge dose of HBV vaccine | Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL |
| Number of Participants Reporting Solicited Local Symptoms | During the 4-day follow-up period after the challenge dose of HBV vaccine. | Solicited local symptoms assessed include pain, redness and swelling |
| Number of Participants Reporting Solicited General Symptoms | During the 4-day follow-up period after the challenge dose of HBV vaccine. | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache |
| Number of Participants Reporting Unsolicited Adverse Events | During the 31-day follow-up period after the challenge dose of HBV vaccine. | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Participants Reporting Serious Adverse Events (SAE) | After the challenge dose of HBV vaccine. | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
Countries
Germany
Participant flow
Recruitment details
One additional subject, enrolled but not vaccinated, was not included in the number of subjects under STARTED
Participants by arm
| Arm | Count |
|---|---|
| Group Engerix Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine) | 300 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Group Engerix |
|---|---|
| Age, Continuous | 7.7 years STANDARD_DEVIATION 0.46 |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 159 / 300 |
| serious Total, serious adverse events | 1 / 300 |
Outcome results
Primary
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
Time frame: One month after the challenge dose of HBV vaccine
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group Engerix | Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value | 275 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: After the challenge dose of HBV vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group Engerix | Number of Participants Reporting Serious Adverse Events (SAE) | 1 Participants |
Secondary
Number of Participants Reporting Solicited General Symptoms
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Engerix | Number of Participants Reporting Solicited General Symptoms | Fatigue | 44 Participants |
| Group Engerix | Number of Participants Reporting Solicited General Symptoms | Fever (Axillary) | 9 Participants |
| Group Engerix | Number of Participants Reporting Solicited General Symptoms | Gastrointestinal | 23 Participants |
| Group Engerix | Number of Participants Reporting Solicited General Symptoms | Headache | 40 Participants |
Secondary
Number of Participants Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling
Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Engerix | Number of Participants Reporting Solicited Local Symptoms | Pain | 89 Participants |
| Group Engerix | Number of Participants Reporting Solicited Local Symptoms | Redness | 81 Participants |
| Group Engerix | Number of Participants Reporting Solicited Local Symptoms | Swelling | 42 Participants |
Secondary
Number of Participants Reporting Unsolicited Adverse Events
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 31-day follow-up period after the challenge dose of HBV vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group Engerix | Number of Participants Reporting Unsolicited Adverse Events | 71 Participants |
Secondary
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
Time frame: Before challenge dose of HBV vaccine
Population: Analysis was performed on subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Engerix | Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | >= 3.3 mIU/mL | 261 Participants |
| Group Engerix | Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | >= 10 mIU/mL | 235 Participants |
| Group Engerix | Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | >= 100 mIU/mL | 104 Participants |