Clinical trial · Interventional
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs
- 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 papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV-16/18 L1/AS04 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
Secondary outcomes (1)
- measure
- To evaluate safety and reactogenicity throughout the study period.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion criteria: * A female subject between, and including, 10 and 14 years of age at the time of the first vaccination. * Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment. * Subjects must have a negative urine pregnancy test. * Healthy subject before entering the study as established by medical history and clinical examination. * Subject must be of non-childbearing potential. Exclusion criteria: * Pregnant or breastfeeding. * Previous vaccination against HPV. * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality * History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease."
References
Publications (1)
- 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