An observational follow up study of a randomised parallel group phase IV study to evaluate the duration of the immune response to vaccine and non-vaccine HPV types in UK adolescent females who received either Cervarix or Gardasil Human Papillomavirus (HPV) vaccines.

Phase 1

• Conditions: o specific medical condition - immune reponses to HPV vaccination.; MedDRA version: 19.0 Level: PT Classification code 10071146 Term: Human papilloma virus immunisation System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002083-13-GB
• Lead Sponsor: Public Health England

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-21
• Study Completion: 2017-08-31
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

1. Participant is willing and able to give written informed consent for participation.
2. Participation in the original study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time).
• Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified