Phase 3
N=397
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Infections, Papillomavirus · Papillomavirus Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00877877 ↗Enrolled (actual)
397
Serious AEs
2.6%
Results posted
Apr 2011
Primary outcome: Primary: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. — 353; 358 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood sampling (Procedure)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. |
393; 395 | — |
| PRIMARY Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. |
393; 395 | — |
| PRIMARY Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. |
393; 395 | — |
| PRIMARY Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. |
393; 395 | — |
| PRIMARY Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers |
1607.9; 608 | — |
| PRIMARY Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers |
1607.9; 608 | — |
| PRIMARY Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers |
1607.9; 608 | — |
| PRIMARY Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers |
1607.9; 608 | — |
| PRIMARY Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. |
393; 395 | — |
| PRIMARY Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers |
1607.9; 608 | — |
| PRIMARY Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers |
1607.9; 608 | — |
| PRIMARY Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. |
393; 395 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
- A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
- Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.
Exclusion Criteria
- 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.
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
- Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
Data sourced from ClinicalTrials.gov (NCT00877877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.