Clinical trial · Interventional
Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix™ | Biological | — | UNRESOLVED |
| Havrix™-based investigational formulation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cervarix Group
- description
- Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
- interventionNames
- Biological: Cervarix™
- type
- ACTIVE_COMPARATOR
- label
- Havrix Group
- description
- Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
- interventionNames
- Biological: Havrix™-based investigational formulation
Primary outcomes (2)
- measure
- Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * A woman between, and including, 15 and 25 years of age at the time of the first vaccination. * Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent). * Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study. * Subject must have a negative urine pregnancy test. * Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series. * Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements. * Subject must have intact cervix. Exclusion Criteria: * Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. * A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8). * Previous administration of components of the investigational vaccine. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * Previous vaccination against human papillomavirus (HPV). * History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease. * History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. * Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. * Hypersensitivity to latex. * Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * History of chronic condition(s) requiring treatment. * Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window. * Acute disease at the time of enrolment. * Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.
References
Publications (19)
- DERIVEDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. PMID 41276263
- DERIVEDLehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669. PMID 35149535
- DERIVEDWelby S, Rosillon D, Feng Y, Borys D. Progression from human papillomavirus (HPV) infection to cervical lesion or clearance in women (18-25 years): Natural history study in the control arm subjects of AS04-HPV-16/18 vaccine efficacy study in China between 2008 and 2016. Expert Rev Vaccines. 2022 Mar;21(3):407-413. doi: 10.1080/14760584.2022.2021077. Epub 2022 Jan 24. PMID 34939897
- DERIVEDAdhikari I, Eriksson T, Luostarinen T, Apter D, Lehtinen M. Is the risk of cervical atypia associated with the interval between menarche and the start of sexual activity? A population-based cohort study. BMJ Open. 2019 Sep 11;9(9):e030091. doi: 10.1136/bmjopen-2019-030091. PMID 31511286
- DERIVEDCastellsague X, Paavonen J, Jaisamrarn U, Wheeler CM, Skinner SR, Lehtinen M, Naud P, Chow SN, Del Rosario-Raymundo MR, Teixeira JC, Palmroth J, de Carvalho NS, Germar MJ, Peters K, Garland SM, Szarewski A, Poppe WA, Romanowski B, Schwarz TF, Tjalma WA, Bosch FX, Bozonnat MC, Struyf F, Dubin G, Rosillon D, Baril L; HPV PATRICIA Study Group. Risk of first cervical HPV infection and pre-cancerous lesions after onset of sexual activity: analysis of women in the control arm of the randomized, controlled PATRICIA trial. BMC Infect Dis. 2014 Oct 30;14:551. doi: 10.1186/s12879-014-0551-y.