Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

Public Health England400 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

400

Conditions

HPV Infections

Interventions

CervarixBIOLOGICAL

Three doses of Cervarix at month 0, 1 and 6.

GardasilBIOLOGICAL

Three doses of Gardasil at month 0, 1 and 6.

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Public Health England

Stevenage, Hertfordshire, United Kingdom

Professor Elizabeth Miller

Gloucester, United Kingdom

Public Health England

London, United Kingdom

Outcomes

Primary Outcomes

Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45

Time frame: 18 months from enrollment

Secondary Outcomes

Determine differences in vaccine formulation and their impact on cross protection.

Time frame: 24 months from enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.