Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Infections, Papillomavirus
• Papillomavirus Vaccines

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

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