A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

Trial Title: A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

NCT ID: NCT05496231

Condition: Cervical Intraepithelial Neoplasia

Conditions: Official terms:
Uterine Cervical Dysplasia

Conditions: Keywords:
human papillomavirus
infection
vaccine
women's health

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: Observer-blinded for study vs comparator vaccine; double-blinded for 3 formulations of study vaccine

Intervention:

Intervention type: Biological
Intervention name: HPV9 High formulation
Description: 3 doses of a high formulation investigational adjuvanted HPV9 vaccine intramuscularly (IM) on Day 1, Month 2, and Month 6.
Arm group label: Human Papilloma Virus 9-valent (HPV9) High Group

Other name: Click here to enter text.

Intervention type: Biological
Intervention name: HPV9 Medium formulation
Description: 3 doses of a medium formulation investigational adjuvanted HPV9 vaccine administered IM on Day 1, Month 2, and Month 6.
Arm group label: Human Papilloma Virus 9-valent (HPV9) Med Group

Intervention type: Biological
Intervention name: HPV9 Low formulation
Description: 3 doses of a low formulation investigational adjuvanted HPV9 vaccine administered IM on Day 1, Month 2, and Month 6.
Arm group label: Human Papilloma Virus 9-valent (HPV9) Low Group

Intervention type: Biological
Intervention name: Gardasil 9
Description: 3 doses of the marketed HPV vaccine (Gradasil 9) administered IM on Day 1, Month 2, and Month 6.
Arm group label: Gardasil 9 (Gar9) Group

Summary: The Main purpose of this study is to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Healthy participants as established by medical history and clinical examination before entering into the study. 2. For Step 1 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. 4. Written informed consent obtained from the participant prior to performance of any study specific procedure (for participants below the legal age of consent as per local regulations, written informed consent must be obtained from the participant/participant's parent[s]/legally authorized representatives [LAR{s}] and, in addition, the participant should sign and personally date a written informed assent). 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 (e.g., completion of the eDiary, return for follow-up visits). 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. 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 (no laboratory testing required). 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 (MPL) 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* *In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is licensed and used according to its Product Information. 17. Administration of long-acting immune-modifying drugs at any time during the study period. 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/ ≥0.5 milligram/kilogram/day (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 dependents, family, or household members. 24. Child in care.

Gender: Female

Gender based: Yes

Gender description: Only female participants, between 16-26 years of age are included in the study.

Minimum age: 16 Years

Maximum age: 26 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: GSK Investigational Site

Address:
City: Norfolk
Zip: 68701
Country: United States

Start date: August 22, 2022

Completion date: June 14, 2024

Lead sponsor:
Agency: GlaxoSmithKline
Agency class: Industry

Source: GlaxoSmithKline

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05496231