Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.
1 other identifier
interventional
116
2 countries
17
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2008
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedStudy Start
First participant enrolled
January 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 15, 2009
CompletedJune 26, 2018
October 1, 2016
11 months
October 17, 2007
November 12, 2009
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
At Day 7 and Month 1 (Day 30)
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
At Day 7 and at Month 1 (Day 30)
Secondary Outcomes (15)
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
At Month 7 and Month 18
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
At Month 7 and Month 18
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
Day 0, Month 1 (Day 30), Month 7 and Month 18
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
Day 7, Month 1 (Day 30), Month 7 and Month 18
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Day 0, Month 1 [Day 30], Month 7 and Month 18
- +10 more secondary outcomes
Study Arms (2)
Cervarix™ 4-Dose Group
EXPERIMENTALSubjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Cervarix™ 3-Dose Group
EXPERIMENTALSubjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Interventions
Intramuscular injection, one or three doses
Eligibility Criteria
You may qualify if:
- A subject whom the investigator believes that she can and will comply with the requirements of the protocol
- Must have received three doses of study vaccine or placebo control in study 580299/001.
- Must have completed study 580299/007.
- Written informed consent must be obtained from the subject prior to enrollment in the study.
- Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
- Subject must have a negative urine pregnancy test.
- Subject must be at least three months post-termination of a pregnancy.
- Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.
You may not qualify if:
- Pregnant or breastfeeding.
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- previous administration of components of the investigational vaccine outside of protocol 580299/001.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
- Hypersensitivity to latex
- Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Cancer or autoimmune disease under treatment.
- Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
- Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
- Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
San Francisco, California, 94118, United States
GSK Investigational Site
Augusta, Georgia, 30912-3500, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Grove City, Pennsylvania, 16127, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Seattle, Washington, 98105, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
GSK Investigational Site
Langley, British Columbia, V3A 4H9, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 0J9, Canada
GSK Investigational Site
Toronto, Ontario, M4N 3M5, Canada
Related Publications (3)
Moscicki AB, Wheeler CM, Romanowski B, Hedrick J, Gall S, Ferris D, Poncelet S, Zahaf T, Moris P, Geeraerts B, Descamps D, Schuind A. Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women. Vaccine. 2012 Dec 17;31(1):234-41. doi: 10.1016/j.vaccine.2012.09.037. Epub 2012 Oct 11.
PMID: 23063422BACKGROUNDMoscicki B et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
BACKGROUNDMoscicki B et al. Anamnestic response to non-vaccine types elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2007
First Posted
October 18, 2007
Study Start
January 14, 2008
Primary Completion
December 22, 2008
Study Completion
December 1, 2009
Last Updated
June 26, 2018
Results First Posted
December 15, 2009
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.