Overview

This trial is active, not recruiting.

Condition infections, papillomavirus
Treatment blood sampling
Phase phase 3
Sponsor GlaxoSmithKline
Start date May 2009
End date January 2010
Trial size 529 participants
Trial identifier NCT00877877, 111375

Summary

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
blood sampling
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120

Primary Outcomes

Measure
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
time frame: At Month 60
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
time frame: At Month 72
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
time frame: At Month 84
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
time frame: At Month 60
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
time frame: At month 72
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
time frame: At Month 84
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
time frame: At Months 96, 108 and 120
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
time frame: At Months 96, 108 and 120

Secondary Outcomes

Measure
Number of Subjects With Serious Adverse Events (SAEs)
time frame: From Month 48 to Month 60
Number of Subjects With Serious Adverse Events (SAEs)
time frame: From Month 72 to Month 84
Number of Subjects With Serious Adverse Events (SAEs)
time frame: From Month 60 to Month 72
Number of Subjects With Serious Adverse Events (SAEs)
time frame: From Month 84 to Month 96
Anti-HPV-16/18 Antibody Titers in Efficacy Studies NCT00689741/NCT00120848/NCT00518336
time frame: At Months 60, 72, 84, 96, 108 and 120
Number of Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values in Efficacy Studies NCT00689741/NCT00120848/NCT00518336
time frame: At Months 60, 72, 84, 96, 108 and 120
Anti-HPV-16/18 Antibody Titers Elicited After Natural Infection (Study 580299/008 (NCT00122681))
time frame: At Month 0
Number of Subjects With Serious Adverse Events (SAEs)
time frame: From Month 48 to Month 120

Eligibility Criteria

Female participants from 15 years up to 24 years old.

Inclusion Criteria: - Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study. - A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013. - Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject. Exclusion Criteria: - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. - Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. - Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013. - Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. - Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.

Additional Information

Official title Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (580299) in Healthy Female Subjects
Description Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study. Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.