Phase 3
Completed N=227
A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study
Source: ClinicalTrials.gov NCT03355820 ↗Enrolled (actual)
227
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study — 223 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the persistence of immune response in subjects who received the HPV-16/18 vaccine, seven to eight years after the last dose of primary vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study |
223 | — |
| PRIMARY Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study |
223 | — |
| PRIMARY Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study |
1236.3 | — |
| PRIMARY Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study |
535.6 | — |
| SECONDARY Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies |
223 | — |
| SECONDARY Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies |
223 | — |
| SECONDARY Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies |
1236.3 | — |
| SECONDARY Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies |
535.6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects/subject's parents/legally acceptable representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject or subject's parents/LAR(s) prior to performing any study specific procedure.
- Written informed assent obtained from the subjects below the legal age of consent.
- Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine which may have an impact on the study objectives) during the period starting 30 days (Day 29 to Day 1) before the study visit.
- Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Previous vaccination against HPV outside the HPV-058 study.
- Subjects with contraindications related to blood draw such as blood disorders and anticoagulants use.
Data sourced from ClinicalTrials.gov (NCT03355820). 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. Informational only — not medical advice.