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.

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. - HPV vaccinee follow up from previous studyEUDRACT study 2008-006773-32

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002083-13-GB

Enrollment

198

Registered

2016-07-21

Start date

2016-07-21

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No 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

Interventions

Trade Name: Gardasil Product Name: Gardasil Product Code: n/a Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Technical version: The measurement of antibody titres elicited to HPV vaccine and non-vaccine types following vaccination with either Cervarix or Gardasil 5-7 years post first immunisation and comparison between vaccines as well as over time. Lay version: To measure how much antibody is still present is in the blood of those vaccinated in our original study 5-7 years after they were vaccinated with either Cervarix or Gardisil HPV vaccines, including comparing the two groups with each other. ;Secondary Objective: n/a;Timepoint(s) of evaluation of this end point: 5-7 years after the first dose of vaccine.; Primary end point(s): Technical Version: The measurement of antibody titres elicited to HPV vaccine and non-vaccine types following vaccination with either Cervarix or Gardasil at 5-7 years post first immunisation and comparison between vaccines and over time. Lay Version: To assess the immune responses to two Human Papillomavirus vaccines on average 5-7 years after the first dose of vaccine.	—

Measure

Time frame

Main Objective: Technical version: The measurement of antibody titres elicited to HPV vaccine and non-vaccine types following vaccination with either Cervarix or Gardasil 5-7 years post first immunisation and comparison between vaccines as well as over time. Lay version: To measure how much antibody is still present is in the blood of those vaccinated in our original study 5-7 years after they were vaccinated with either Cervarix or Gardisil HPV vaccines, including comparing the two groups with each other. ;Secondary Objective: n/a;Timepoint(s) of evaluation of this end point: 5-7 years after the first dose of vaccine.; Primary end point(s): Technical Version: The measurement of antibody titres elicited to HPV vaccine and non-vaccine types following vaccination with either Cervarix or Gardasil at 5-7 years post first immunisation and comparison between vaccines and over time. Lay Version: To assess the immune responses to two Human Papillomavirus vaccines on average 5-7 years after the first dose of vaccine.

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Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

United Kingdom

Contacts

Public ContactJo Southern

Public Health England

jo.southern@phe.gov.uk0208 327 6084

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026