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

Public Health England

Status and phase: Completed; Phase 4

Conditions: HPV Infections

Treatments: Biological: Gardasil; Biological: Cervarix

Study type: Interventional

Funder types: Other

Identifiers

NCT00956553

HPV CSP01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 400 patients

Sex: Female

Ages: 13 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Cervarix

Active Comparator group

Description:

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.

Treatment:

Biological: Cervarix

Gardasil

Active Comparator group

Description:

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.

Treatment:

Biological: Gardasil