Phase 3
N=100
Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years
Infections, Papillomavirus
Bottom Line
View on ClinicalTrials.gov: NCT00456807 ↗Enrolled (actual)
100
Serious AEs
—
Results posted
Jul 2010
Primary outcome: Primary: Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines — 877.4; 19.5; 738.5; 22.3 cells per million CD4/CD8 T-cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Biological); Cervarix TM (Biological)
- Age
- Adult, Older Adult · 26+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines |
877.4; 19.5; 738.5; 22.3; 2.0; 2.0 | — |
| PRIMARY Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18 |
517.1; 101.4; 304.4; 33.1; 354.7; 68.4 | — |
| PRIMARY Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values |
52; 14; 49; 14; 52; 7 | — |
| PRIMARY Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies |
2050.4; 6.9; 1517.1; 7.2; 761.4; 4.8 | — |
| PRIMARY Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies |
129.5; 0; 99.9; 0; 67.2; 0 | — |
| PRIMARY Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples |
0.903; 0.898; 0.901; 0.876 | — |
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. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- A female enrolled in study 104820 and who received three doses of study vaccine/control.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject prior to enrolment in this ancillary study.
Exclusion Criteria
- Pregnancy.
- Administration of any HPV vaccine other than that foreseen by the study protocol.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
- Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
- Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.
Data sourced from ClinicalTrials.gov (NCT00456807). 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.