Healthy volunteers (Hepatitis B Virus infection) MedDRA version: 20.0 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: GSKVx000000030242
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Other descriptive name: G
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participants who the investigator believe can and will comply with the requirements of the protocol. INC#1 -Written informed consent obtained from the participant prior to performance of any study-specific procedure. INC#2 -Healthy participants as established by medical history, clinical examination and clinical laboratory assessment before entering the study. INC#3 -A male or female between, and including, 18 and 45 years at the time of the first study intervention administration. INC#4 -Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. INC#5 -Female participants of childbearing potential may be enrolled in the study, if the participant: INC#6 •has practiced adequate contraception for 1 month prior to study intervention administration, and •has a negative pregnancy test on the day of study intervention administration, and •has agreed to continue adequate contraception during the entire treatment period and for at least 3 months after completion of the study intervention administration series. •blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 122 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical conditions -Previous vaccination against Hepatitis B. EXC#1 -Positive for anti-HBs antibodies or anti-HBc antibodies or HBsAg. EXC#2 -Any previous administration of monophosphoryl lipid (MPL) and/or AS37. EXC#3 -Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. EXC#4 -Any confirmed or suspected autoimmune disease. EXC#5 -History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). EXC#6 -Recurrent history or uncontrolled neurological disorders or seizures. EXC#7 -Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. EXC#8 -Any clinically significant* haematological and/or biochemical laboratory abnormality. EXC#9 *The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant. -Any past or current malignancies and lymphoproliferative disorders. EXC#10 Prior/Concomitant therapy -Use of any investigational or non-registered product (drug or vaccine) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) or their planned use during the study period. EXC#11 -Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study intervention(s) administration with the exception of influenza vaccine (pandemic or seasonal). EXC#12 -A vaccine not foreseen by the study protocol administered during the period starting at Visit 1 or 30 days before each dose and ending 30 days after the last dose of study intervention(s) administration*, with the exception of influenza vaccine (pandemic or seasonal). EXC#13 *In case emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by public health authorities outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine, provided it is licensed/authorised and used according to its Product Information. -Administration of long-acting immune-modifying drugs at any time during the study period. EXC#14 -Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult participants/ =0.5 mg/kg/day. Inhaled and topical steroids are allowed. EXC#15 -Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period. EXC#16 Prior/Concurrent clinical study experience -Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational intervention. EXC#17 Other exclusions -Pregnant or lactating female. EXC#18 -Female planning to become pregnant or planning to discontinue contraceptive precautions. EXC#19 -History of chronic alcohol consumption and/or drug abuse. EXC#20 -Any study personnel or their immediate dependants, family, or household members. EXC#21 Specific exclusion for MRI-asses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the reactogenicity and safety in all study groups.;Secondary Objective: To evaluate the humoral immune response in all study groups.;Timepoint(s) of evaluation of this end point: 1, 3, 5, 7, 9. Within 14 days after Dose 1 administration (Dose 1 administered at Day 1) 2, 4, 6, 8, 10. Within 14 days after Dose 2 administration (Dose 2 administered at Day 31) 11. Throughout the entire study period (from Day 1 to Day 361) 12. Throughout the entire study period (from Day 1 to Day 361) 13. Throughout the entire study period (from Day 1 to Day 361) 14. Throughout the entire study period (from Day 1 to Day 361) 15. At baseline (pre-vaccination, Day 1) and at Day 8 16. At baseline (pre-vaccination, Day 1) and at Day 31 17. At baseline (pre-vaccination, Day 1) and at Day 38 18. At baseline (pre-vaccination, Day 1) and at Day 61 19. At Day 1 20. At Day 8 21. At Day 31 22. At Day 38 23. At Day 61;Primary end point(s): 1. Percentage of participants with solicited administration site events 2. Percentage of participants with solicited administration site events 3. Percentage of participants with solicited systemic events 4. Percentage of participants with solicited systemic events 5. Duration of solicited administration site events 6. Duration of solicited administration site events 7. Duration of solicited systemic events 8. Duration of solicited systemic events 9. Percentage of participants with any unsolicited adverse events (AEs) 10. Percentage of participants with any unsolicited adverse events (AEs) 11. Percentage of participants with serious AEs (SAEs) 12. Percentage of participants with medically attended AEs (MAEs) 13. Percentage of participants with AEs leading to study withdrawal 14. Percentage of participants with potential mediated immune diseases (pIMDs) 15. Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 8 16. Percentage of participants with changes fro | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Anti-HBs antibody concentrations 2. Percentage of participants seroconverted for anti-HBs 3. Percentage of participants seroprotected for anti-HBs ;Timepoint(s) of evaluation of this end point: 1, At Day 1, Day 31, Day 61 and Day 361 2, 3, At Day 31, Day 61 and Day 361 | — |
Countries
Belgium, Germany, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed