Clinical trial · Interventional
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
NCT00956553CI-TRIAL-00047437HPV CSP01completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
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 |
|---|---|---|---|
| HPV Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix | Biological | — | UNRESOLVED |
| Gardasil | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cervarix
- description
- Three doses of Cervarix at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7.
- interventionNames
- Biological: Cervarix
- type
- ACTIVE_COMPARATOR
- label
- Gardasil
- description
- Three doses of Gardasil at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7.
- interventionNames
- Biological: Gardasil
Primary outcomes (1)
- measure
- Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Aged between 13 and 15 years at the time of the first immunisation * Female * No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO. * Written informed consent obtained from parent or guardian of subject Exclusion Criteria: * Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill). * Breast-feeding mothers * Allergic to vaccine components
References
Publications (4)
- RESULTHaskins-Coulter T, Southern J, Andrews N, Miller E. Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-9. doi: 10.1080/21645515.2016.1277846. Epub 2017 Mar 20. PMID 28319456
- 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
- DERIVEDGodi A, Panwar K, Haque M, Cocuzza CE, Andrews N, Southern J, Turner P, Miller E, Beddows S. Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix(R) or Gardasil(R) vaccine. Vaccine. 2019 Apr 24;37(18):2455-2462. doi: 10.1016/j.vaccine.2019.03.052. Epub 2019 Mar 27. PMID 30926298
- DERIVEDDraper E, Bissett SL, Howell-Jones R, Waight P, Soldan K, Jit M, Andrews N, Miller E, Beddows S. A randomized, observer-blinded immunogenicity trial of Cervarix((R)) and Gardasil((R)) Human Papillomavirus vaccines in 12-15 year old girls. PLoS One. 2013 May 1;8(5):e61825. doi: 10.1371/journal.pone.0061825. Print 2013. PMID 23650505