Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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HPV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cervarix

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

Gardasil

Intervention Type BIOLOGICAL

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

Interventions

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Cervarix

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

Intervention Type BIOLOGICAL

Gardasil

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes