Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Infections, Papillomavirus
- Sponsor
- GlaxoSmithKline
- Enrollment
- 798
- Locations
- 1
- Primary Endpoint
- Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject prior to enrolment.
- •Subject must have a negative urine pregnancy test.
- •Healthy subject before entering the study entry as established by medical history and physical examination.
- •Subject must be of non-childbearing potential.
Exclusion Criteria
- •pregnant or breastfeeding subject.
- •previous vaccination against human papillomavirus (HPV).
- •Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
- •History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
Outcomes
Primary Outcomes
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Time Frame: At Month 7
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
Time Frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay \[ELISA\] units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Secondary Outcomes
- Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18(At Month 2)
- Number of Subjects With New Onset Chronic Diseases (NOCDs)(From Month 0 to Month 7)
- Number of Subjects With Medically Significant Adverse Events (MSAEs)(From Month 0 to Month 7)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Day 0-29) post vaccination)
- Number of Subjects With MSAEs(From Month 0 to Month 12)
- Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18(At Month 2)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-days (Day 0-6) post-vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-days (Day 0-6) post-vaccination)
- Number of Subjects With (NOCDs)(From Month 0 to Month 12)
- Number of Subjects With Serious Adverse Events (SAEs)(From Month 0 to Month 12)