Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

HPV Infections Clinical Trial

— HPV CSP01  

Official title:

A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956553
• Other study ID #: HPV CSP01
• Status: Completed
• Phase: Phase 4
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: August 2018
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV Infections
• Papillomavirus Infections

Intervention

Biological:
• Cervarix
Three doses of Cervarix at month 0, 1 and 6.
• Gardasil
Three doses of Gardasil at month 0, 1 and 6.

Locations

Country	Name	City	State
United Kingdom	Professor Elizabeth Miller	Gloucester
United Kingdom	Public Health England	London
United Kingdom	Public Health England	Stevenage	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45		18 months from enrollment
Secondary	Determine differences in vaccine formulation and their impact on cross protection.		24 months from enrollment

External Links

•   Published study results