Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls (HPV CSP01)

September 29, 2020 updated by: Public Health England

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Gloucester, United Kingdom
        • Professor Elizabeth Miller
      • London, United Kingdom, NW9 5HT
        • Public Health England
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom
        • Public Health England

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Biological: Cervarix
Three doses of Cervarix at month 0, 1 and 6.
ACTIVE_COMPARATOR: 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.
Biological: Gardasil
Three doses of Gardasil at month 0, 1 and 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Time Frame: 18 months from enrollment
18 months from enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine differences in vaccine formulation and their impact on cross protection.
Time Frame: 24 months from enrollment
24 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (ESTIMATE)

August 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV CSP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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