Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Bio HPV-16/18. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00196937

Purpose

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Prophylaxis HPV-16/18 Infections and Cervical Neoplasia	Biological: HPV-16/18 L1/AS04	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3, Open, Age-Stratified Study to Assess Immunogenicity & Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-Dose Schedule (0,1,6 Mths) in Healthy Female Subjects Aged 15 - 55 Yrs and Long Term FU

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

For 580299-014: Anti-HPV-16 and anti-HPV-18 seroconversion rates assessed by ELISA in women 15 -25 years of age and women 26 - 45 years of age. [ Time Frame: At Month 7 ]
For extension: Anti-HPV-16 and anti-HPV-18 antibody titres assessed by ELISA in all subjects [ Time Frame: At each time point (Months 18, 24, 36 and 48) ]

Secondary Outcome Measures:

For 580299-014: Anti-HPV-16 and anti-HPV-18 seroconversion rates assessed by ELISA in women aged 46 - 55 years. [ Time Frame: At Month 7 ]
For 580299-014: Anti-HPV-16 and anti-HPV-18 antibody titres assessed by ELISA in all subjects. [ Time Frame: At each time point ]
For 580299-014: Anti-HPV-16 and anti-HPV-18 seroconversion rates assessed by ELISA in all subjects. [ Time Frame: At Month 2 and Month 12 ]
For 580299-014: Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms [ Time Frame: Within 7 days (days 0 - 6) after each vaccination ]
For 580299-014: Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days (days 0 - 29) after each vaccination ]
For 580299-014: Occurrence and relationship to vaccination of SAEs [ Time Frame: Throughout the study period (up to Month 7) ]
For 580299-014: Occurrence of NOCDs and other medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases, regardless of causal relationship to vaccination and intensity [ Time Frame: Throughout the study period (up to Month 7) ]
For 580299-014: Occurrence of SAEs, NOCDs and other medically significant conditions [ Time Frame: Up to Month 12 (follow-up visit) ]
Ext.: Occ.of pregnancies,SAEs,NOCDs & other medically sign. cond. prompting ER visits or physician visits that are not rel.to common diseases or routine visits for phys. examination or vaccination, or SAEs that are not rel.to common diseases [ Time Frame: Throughout the study period ]
For extension: Anti-HPV-16 and anti-HPV-18 antibody titres assessed by ELISA [ Time Frame: At each time point (Months 0, 7, 12, 18, 24, 36 and 48) ]
For extension: Anti-HPV-16 and anti-HPV-18 antibody titres from subjects enrolled in studies 580299-001/580299-007 subjects assessed by ELISA [ Time Frame: At each time point (Months 0, 7, 12, 18, 24, 36 and 48) ]
For extension: Anti-HPV-16 and anti-HPV-18 antibody titres in cervical samples in subjects who had cervical samples collected. [ Time Frame: At Months 18 and 24 ]
For extension: Total IgG evaluation in blood and cervical samples in the subset of subjects who had cervical samples collected. [ Time Frame: At Months 18 and 24 ]

Estimated Enrollment:	660
Study Start Date:	October 2004
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix.

Eligibility

Ages Eligible for Study:	15 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria for 580299-014:

A women who the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol.
A women between, and including, 15 and 55 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject should sign and personally date a written informed assent).
Free of obvious health problems.
Subject must have a negative urine pregnancy test.
Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore become of childbearing potential must agree to follow the same precautions

Inclusion criteria for extension studies

A female who enrolled in 580299-014 study and received three doses of vaccine.
Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject must sign and personally date a written informed assent).

Exclusion criteria for 580299-014:

Pregnant or breastfeeding.
A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
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 before and 30 days after the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
Previous administration of components of the investigational vaccine
Previous vaccination against HPV.
Any medically diagnosed or suspected 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 vaccine.
Hypersensitivity to latex.
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
History of chronic condition(s) requiring treatment.
Administration of immunoglobulins and/or any blood product within 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
Acute disease at the time of enrolment.

Exclusion criteria for extension studies

Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
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 (pharmaceutical product or device).
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196937

Locations

Germany

Würzburg,, Germany

München,, Germany

Berlin,, Germany
Poland

Poznan,, Poland

Bydgoszcz, Poland

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	103514, 105879 (Month 18), 105880 (Month 24), 105881 (Month 36), 105882 (Month 48)
Study First Received:	September 13, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00196937
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

HPV Vaccine Safety

Study placed in the following topic categories:

Virus Diseases
Healthy
Papilloma

ClinicalTrials.gov processed this record on January 16, 2009