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
Last Updated: 2025-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
1080 participants
INTERVENTIONAL
2022-08-22
2024-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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HPV9 High Group
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
HPV9 High formulation
3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
HPV9 Med Group
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
HPV9 Medium formulation
3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
HPV9 Low Group
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
HPV9 Low formulation
3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
Gar9 Group
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
Gardasil 9
3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6.
Interventions
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HPV9 High formulation
3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
HPV9 Medium formulation
3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
HPV9 Low formulation
3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
Gardasil 9
3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6.
Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
26 Years
FEMALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Wheat Ridge, Colorado, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Kissimmee, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
North Miami Beach, Florida, United States
GSK Investigational Site
Pompano Beach, Florida, United States
GSK Investigational Site
Sarasota, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Evansville, Indiana, United States
GSK Investigational Site
South Bend, Indiana, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Covington, Louisiana, United States
GSK Investigational Site
Elkridge, Maryland, United States
GSK Investigational Site
Saginaw, Michigan, United States
GSK Investigational Site
Jefferson City, Missouri, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Norman, Oklahoma, United States
GSK Investigational Site
North Charleston, South Carolina, United States
GSK Investigational Site
Chattanooga, Tennessee, United States
GSK Investigational Site
Carrollton, Texas, United States
GSK Investigational Site
Corpus Christi, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Humble, Texas, United States
GSK Investigational Site
Humble, Texas, United States
GSK Investigational Site
Irving, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Tomball, Texas, United States
GSK Investigational Site
West Jordan, Utah, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Hradec Králové, , Czechia
GSK Investigational Site
Olomouc, , Czechia
GSK Investigational Site
Olomouc, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Dijon, , France
GSK Investigational Site
La Roche-sur-Yon, , France
GSK Investigational Site
La Tronche, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Rennes, , France
GSK Investigational Site
Tours, , France
GSK Investigational Site
Schwerin, , Germany
GSK Investigational Site
Würzburg, , Germany
GSK Investigational Site
Kaunas, , Lithuania
GSK Investigational Site
Kaunas, , Lithuania
GSK Investigational Site
Kaunas, , Lithuania
GSK Investigational Site
Kaunas, , Lithuania
GSK Investigational Site
Vilnius, , Lithuania
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Skierniewice, , Poland
GSK Investigational Site
Warsaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-000090-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
213749
Identifier Type: -
Identifier Source: org_study_id
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