Clinical trial · Interventional
Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years
Complementary Testing to Further Evaluate the Immunogenicity of a GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Aged Over 26 Years Enrolled in Study 104820.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix TM | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cervarix Group
- description
- Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
- interventionNames
- Biological: Cervarix TM
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Subjects who received 3 doses of placebo during the primary study (NCT00294047).
- interventionNames
- Biological: Placebo
Primary outcomes (6)
- measure
- Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available