Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age
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Purpose
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
HPV-16/18 Infections and Cervical Neoplasia |
Biological: Cervarix TM |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years |
- Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 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.
- Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]Titer given as geometric mean titer (GMT).
- Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 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.
- Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]Titer given as GMT.
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ] [ Designated as safety issue: No ]Solicited local symptoms assessed include pain, redness and swelling at the injection site.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ] [ Designated as safety issue: No ]Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
- Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 30-day (Days 0-29) period following each vaccination ] [ Designated as safety issue: No ]An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs) [ Time Frame: During the entire study period (up to Month 18 or up to Month 12) ] [ Designated as safety issue: No ]
Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.
NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
- Number of Subjects With Pregnancies and Their Outcomes [ Time Frame: During the entire study period (up to Month 18 or Month 12) ] [ Designated as safety issue: No ]
Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6
Number of pregnancies and pregnancy outcomes.
- Number of Subjects Completing the 3-dose Vaccination Schedule [ Time Frame: After the third vaccine dose ] [ Designated as safety issue: No ]
| Enrollment: | 805 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cervarix-12 Group
Women received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule
|
Biological: Cervarix TM
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
Other Name: HPV vaccine (GSK580299)
|
|
Active Comparator: Cervarix-6 Group
Women received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule.
|
Biological: Cervarix TM
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Eligibility| Ages Eligible for Study: | 15 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
- A female between and including 15 and 25 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 the subject's parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and/or clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
- Subject who had no more than 6 lifetime sexual partners prior to enrolment.
Exclusion Criteria:
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of 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 patient is outside of specified window.
- 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).
- 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
- Cancer or autoimmune disease under treatment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Pregnant or breastfeeding female.
- Female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period starting at visit one and up to two months after the last vaccine dose.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or lab tests.
Contacts and Locations| Italy | |
| GSK Investigational Site | |
| Brescia, Lombardia, Italy, 25123 | |
| GSK Investigational Site | |
| Lodi, Lombardia, Italy, 26900 | |
| GSK Investigational Site | |
| Milano, Lombardia, Italy, 20122 | |
| GSK Investigational Site | |
| Cagliari, Sardegna, Italy, 09127 | |
| GSK Investigational Site | |
| Sassari, Sardegna, Italy, 07100 | |
| GSK Investigational Site | |
| Palermo, Sicilia, Italy, 90127 | |
| GSK Investigational Site | |
| Ragusa, Sicilia, Italy, 97100 | |
| Romania | |
| GSK Investigational Site | |
| Bucharest, Romania, 077190 | |
| GSK Investigational Site | |
| Bucharest, Romania, 010507 | |
| GSK Investigational Site | |
| Bucharest, Romania | |
| GSK Investigational Site | |
| Cluj-Napoca, Romania, 400217 | |
| GSK Investigational Site | |
| Sibiu, Romania | |
| GSK Investigational Site | |
| Sibiu, Romania, 550245 | |
| Slovakia | |
| GSK Investigational Site | |
| Dolny Kubin, Slovakia, 026 01 | |
| GSK Investigational Site | |
| Nova Dubnica, Slovakia, 018 51 | |
| GSK Investigational Site | |
| Trencin, Slovakia, 911 01 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00552279 History of Changes |
| Other Study ID Numbers: | 109179 |
| Study First Received: | October 30, 2007 |
| Results First Received: | February 12, 2010 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Slovakia: State Institute for Drug Control Romania: National Drug Agency Italy: Comitato Etico Azienda Ospedaliera Spedali Civili di Brescia United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
HPV cervical cancer papillomavirus Human papillomavirus (HPV) vaccine |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 13, 2013