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Completed

NCT Number: NCT00956553

Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

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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Key information

Conditions

HPV Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

13 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Public Health England, Stevenage, Hertfordshire, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervarix

Biological

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

GARDASIL

Biological

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

Primary outcomes

  1. 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

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

    Time frame: 24 months from enrollment

Sponsors and collaborators

Lead sponsor

Public Health England

Other Gov

Registry information

Official study title

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

Acronym: HPV CSP01

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Aug 11, 2009
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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