Infections, Papillomavirus Clinical Trial
Official title:
A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
Verified date | December 2019 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic
types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also
evaluating novel HPV vaccines formulations. This study will evaluate the long-term
immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects
who received the novel vaccine or the control vaccine administered in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Status | Completed |
Enrollment | 383 |
Est. completion date | January 30, 2007 |
Est. primary completion date | January 30, 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 25 Years |
Eligibility |
Inclusion Criteria: - A female who enrolled in the study 102115 and received three doses of vaccine. - Written informed consent obtained from the subject prior to enrolment. Exclusion Criteria: - Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine). - Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. - Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. - Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period. |
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Bruxelles | |
Belgium | GSK Investigational Site | Gent | |
Belgium | GSK Investigational Site | Leuven | |
Belgium | GSK Investigational Site | Liège | |
Belgium | GSK Investigational Site | Tienen | |
Belgium | GSK Investigational Site | Wilrijk | |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Golden | Colorado |
United States | GSK Investigational Site | Salt Lake City | Utah |
United States | GSK Investigational Site | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL). | At Months 18, 24, 36 and 48. | |
Primary | Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies. | Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (=) 8 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Primary | Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies | Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (=) 8 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Primary | Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Primary | Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies. | Antibody titers were expressed as GMTs. The reference cut-off value was = 7 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Primary | Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies | Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (=) 7 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Secondary | Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Secondary | Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies. | Antibody titers were expressed as GMTs. The reference cut-off value was = 59 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Secondary | Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Secondary | Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies. | Antibody titers were expressed as GMTs. The reference cut-off value was = 59 EL.U/mL. | At Months 18, 24, 36 and 48. | |
Secondary | Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs) | NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term) | From Month 0 to Months 18, 24, 36 and 48 | |
Secondary | Number of Subjects With at Least One Medically Significant Condition (MAEs). | MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term). | From Month 0 to Months 18, 24, 36 and 48 | |
Secondary | Number of Subjects With Any Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade. | From Month 0 to Months 18, 24, 36 and 48 | |
Secondary | Number of Subjects With Pregnancy Outcomes. | Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion. | From Month 0 to Month 18 | |
Secondary | Number of Subjects With Pregnancy Outcomes. | Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy. | From Month 0 to Month 24 | |
Secondary | Number of Subjects With Pregnancy Outcomes. | Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion. | From Month 0 to Month 36 | |
Secondary | Number of Subjects With Pregnancy Outcomes. | Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination. | From Month 0 to Month 48 |
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