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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00359619
Other study ID # 108052 (FU month 18)
Secondary ID 1079191079211079
Status Completed
Phase Phase 2
First received
Last updated
Start date September 12, 2006
Est. completion date January 30, 2007

Study information

Verified date December 2019
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Other known NCT identifiers
  • NCT00359502
  • NCT00359528
  • NCT00359827

Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CervarixTM
Subjects were administered three doses of HPV vaccine
HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

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
See also
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Completed NCT00345878 - Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years Phase 3
Completed NCT00947115 - Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects Phase 3
Completed NCT01187927 - Drug Use Investigation for Cervarix® N/A
Completed NCT00169494 - Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18 Phase 3
Completed NCT01190176 - Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects Phase 3
Completed NCT00196937 - Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18 Phase 3
Completed NCT00534638 - Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents Phase 4
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Completed NCT00996125 - Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects Phase 3
Completed NCT00779766 - Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects Phase 3
Completed NCT01953822 - Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom N/A
Completed NCT01153906 - Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination N/A
Completed NCT01207999 - Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer N/A
Completed NCT00693615 - Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females Phase 2
Completed NCT00693966 - Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females Phase 2
Completed NCT00541970 - Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs Phase 1
Completed NCT01627561 - Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old Phase 3