A Phase 3 interventional study of Blood sampling for antibody determination in Cervical Intraepithelial Neoplasia, sponsored by GlaxoSmithKline. Completed at 1 site in China. Open to female participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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Among 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Uterine Cervical Dysplasia · GlaxoSmithKline.
Among the 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline, this one is one of 3 that started in 2018, is one of 5 in phase 3, and was the 7th registered.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
Browse Uterine Cervical Dysplasia studies →None of the 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline is open now. The open studies under Uterine Cervical Dysplasia, anywhere →
Of the 43 Uterine Cervical Dysplasia studies recruiting now, 19 (44%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.
This study: 17 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2018.
This study's enrollment of 228 is above the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Median enrollment 1,080 across the 7 interventional studies, 1 across the 3 observational. Of the 10 that completed or were terminated, 8 (80%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.
Procedure: Blood sampling for antibody determination
In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (\~5 mL) will be taken from all the subjects, at Day 1.
Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study
Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study
Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
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
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, \[Month 72\]" and Row "≥19 EL.U/mL, sero+, \[Month 72\]").
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
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
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- \[Month 72\]" and Row "≥ 18 EL.U/mL, sero+ \[Month 72\]).
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies
Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, \[Month 72\]" and Row "HPV-16, sero+, \[Month 72\]").
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies
Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, \[Month 72\]" and Row "HPV-18, sero+, \[Month 72\]").
Time frame: At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
This study was conducted at a single center in China.
| Milestone | HPV Group |
|---|---|
| Started | 227 |
| Completed | 227 |
| Not completed | 0 |
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).
| Participants | HPV Group |
|---|---|
| Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study | 223 |
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.
| Participants | HPV Group |
|---|---|
| Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study | 223 |
Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.
| EL.U/mL | HPV Group |
|---|---|
| Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study | 1236.3 (1121.8 to 1362.4) |
Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.
| EL.U/mL | HPV Group |
|---|---|
| Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study | 535.6 (478.6 to 599.4) |
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, \[Month 72\]" and Row "≥19 EL.U/mL, sero+, \[Month 72\]").
| Participants | HPV Group |
|---|---|
| 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 |
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- \[Month 72\]" and Row "≥ 18 EL.U/mL, sero+ \[Month 72\]).
| Participants | HPV Group |
|---|---|
| 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 |
Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, \[Month 72\]" and Row "HPV-16, sero+, \[Month 72\]").
| EL.U/mL | HPV Group |
|---|---|
| Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies | 1236.3 (1121.8 to 1362.4) |
Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, \[Month 72\]" and Row "HPV-18, sero+, \[Month 72\]").
| EL.U/mL | HPV Group |
|---|---|
| Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies | 535.6 (478.6 to 599.4) |
Collected over At Day 1. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HPV Group | 0/227 (0%) | 0/227 (0%) | — |
| Age, Continuous(Years) | HPV Group |
|---|---|
| Mean | 21.6 ± 2.3 |
| Sex: Female, Male(Participants) | HPV Group |
|---|---|
| Female | 227 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | HPV Group |
|---|---|
| Asian - East Asian Heritage | 227 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Feb 2018 to primary completion in Jun 2018, 4 months.
Results were first posted in Jun 2019, 11 months after primary completion.
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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