Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

Phase 4

Completed

• Conditions: HPV Infections
• Interventions: Biological: Cervarix; Biological: Gardasil

• Registration Number: NCT00956553
• Lead Sponsor: Public Health England

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.

Study Timeline

• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-09
• Primary Completion: 2012-09
• Study Completion: 2013-09
• Status Verified: 2018-08
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervarix	Cervarix	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.
Gardasil	Gardasil	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.

Primary Outcome Measures

Name	Time	Method
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45	18 months from enrollment

Secondary Outcome Measures

Name	Time	Method
Determine differences in vaccine formulation and their impact on cross protection.	24 months from enrollment

Trial Locations

Locations (2)

Professor Elizabeth Miller; 🇬🇧 Gloucester, United Kingdom

Public Health England; 🇬🇧 London, United Kingdom