Clinical trial NCT00956553: Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Official title: A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HPV Infections
Keywords: HPV
Human Papilloma Virus
Cervical cancer vaccine
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2009-08-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.

Eligibility criteria: 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

Primary outcomes:
measure: Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
timeFrame: 18 months from enrollment
Secondary outcomes:
measure: Determine differences in vaccine formulation and their impact on cross protection.
timeFrame: 24 months from enrollment
Other outcomes:
Locations:
city: Stevenage
country: United Kingdom
facility: Public Health England
state: Hertfordshire
city: Gloucester
country: United Kingdom
facility: Professor Elizabeth Miller
city: London
country: United Kingdom
facility: Public Health England
Study officials:
References:
citation: Haskins-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.
citation: Godi 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.
citation: Draper 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.