Active immunisation for the prevention of human papillomavirus infection MedDRA version: 21.1 Level: PT Classification code 10071146 Term: Human papilloma virus immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Code: GSKVx000000031164
Pharmaceutical Form: Suspension for injection
Other descriptive name: GSKVx000000031358
Concentration unit: µg microgram(s)
Concentration type: not less then
Concentrat
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy participants as established by medical history and clinical examination before entering into the study 2. For Step 1 only (US only): Female between and including 18 and 26 years of age at the time of the first study intervention administration 3. For Step 2: Female between and including 16 and 26 years of age at the time of the first study intervention administration Note: In Germany, only adult participants between and including 18 to 26 years of age are to be included in this clinical study. 4. Written informed consent obtained from the participant and/or participant's parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure 5. Participants and/or participants’ parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol 6. Female participant with no more than 4 lifetime sexual partners prior to enrollment. 7. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study if the participant: - has practiced adequate highly effective contraception for at least 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 intervention period and for 2 months after completion of the study intervention administration series. Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 880 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female. 2. Female planning to become pregnant or planning to discontinue contraceptive precautions. 3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 4. History or current diagnosis of autoimmune disease. 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination 6. Hypersensitivity to latex. 7. Major congenital defects, as assessed by the investigator. 8. History of abnormal Papanicolaou test or abnormal cervical biopsy result. 9. History of external genital/vaginal warts. 10. History of positive HPV test. 11. Acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. 12. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. 13. Previous vaccination against HPV. 14. Previous exposure to monophosphoryl lipid A or AS04 adjuvant. 15. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period. 16. 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 interventions administration 17. Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). 18. Use of systemic cytotoxic agents within the previous 3 months prior to randomization into this study or at any time during the study period. 19. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult participants or =0.5 mg/kg/day with maximum of 20 mg/day for participants under 18 years of age. Inhaled and topical steroids are allowed. 20. Administration of systemic immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period. 21. 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 or a non-investigational intervention 22. History of /current chronic alcohol consumption and/or drug abuse. 23. Any study personnel or their immediate dependants, family, or household members. 24. Child in care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)’s investigational adjuvanted human papillomavirus (HPV) vaccine formulations. • To evaluate the immune response to GSK’s investigational adjuvanted HPV vaccine formulations. ;Secondary Objective: • To evaluate the safety and reactogenicity of GSK’s investigational adjuvanted HPV vaccine formulations. • To evaluate the immune response for all HPV vaccine types for all vaccines.;Primary end point(s): • Percentage of participants reporting each solicited administration site event assessed as Grade 3 in terms of intensity within 7 days (Day 1 – Day 7) after each vaccine dose. • Percentage of participants reporting each solicited systemic event assessed as Grade 3 in terms of intensity within 7 days (Day 1 – Day 7) after each vaccine dose. • Percentage of participants reporting unsolicited adverse event assessed as Grade 3 in terms of intensity classified by Medical Dictionary for Regulatory Activities (MedDRA) within 28 days (Day 1 – Day 28) after each vaccine dose. • Percentage of participants reporting SAEs classified by MedDRA from first vaccination up to study end. • Percentage of participants presenting clinically relevant abnormalities in each biochemical and hematological parameter at Day 7 post-dose 1. • Anti-HPV immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs), 1 month after the third dose (Month 7).;Timepoint(s) of evaluation of this end point: As described above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of participants reporting each solicited administration site event within 7 days (Day 1 –Day 7) after each vaccine dose. • Percentage of participants reporting each solicited systemic event within 7 days (Day 1 – Day 7) after each vaccine dose. • Percentage of participants reporting unsolicited symptoms within 28 days (Day 1 – Day 28) after each vaccine dose. • Percentage of participants reporting pIMDs from first vaccination up to study end. • The percentage of participants who experienced pregnancy and their outcomes from Day 1 of pregnancy up to study end. • Anti-HPV IgG antibody concentration at Day 1, Month 2, Month 3, Month 6, Month 7, and Month 12. • Anti-HPV IgG antibody seroconversion rate at Month 2, Month 3, Month 6, Month 7, and Month 12. • Anti-HPV neutralizing antibody titers at Day 1, Month 3 and Month 7 in all participants, Month 2 in a subset of participants. • Anti-HPV neutralizing antibody seroconversion rate at Month 3 and Month 7. • Correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers at Day 1, Month 2, Month 3, and Month 7. ;Timepoint(s) of evaluation of this end point: As described above | — |
Countries
Bulgaria, Czechia, Czech Republic, Estonia, France, Germany, Lithuania, Poland, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed