Infections, PapillomavirusPhase 3NCT00456807

Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

A Phase 3 study testing Cervarix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 26 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: Cervarix TM
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 2 sitesNetherlands
Study dates: Apr 2007to Jan 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 26 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

GSK Investigational Site
Amsterdam, 1007 MB
GSK Investigational Site
Delft, 2625 AD

Other trials in Netherlands

About this study

Official title: 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.

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: Infections, Papillomavirus
Being tested: Placebo, Cervarix TM
Keywords: Human Papillomavirus
Medical subject headings: Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboBiological
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Cervarix TMBiological
Also called GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Study groups in NCT00456807
Study group	Role	What they receive
Cervarix Group	Experimental	Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). Receives: Biological: Cervarix TM
Placebo Group	Placebo comparator	Subjects who received 3 doses of placebo during the primary study (NCT00294047). Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.
Measured: At Month 12 and Month 18 after first vaccination
Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18
The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.
An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Measured: At Month 12 and Month 18 after first vaccination
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Measured: At Month 12 and Month 18 after first vaccination
Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titers are presented as Geometric Mean Titers (GMTs).
Measured: At Month 12 and Month 18 after first vaccination
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies
Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Measured: At Month 12 and Month 18 after first vaccination
Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples
Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.
Measured: At Month 12 and Month 18 after first vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Jan 2008

First posted5 Apr 2007 (estimated)
Study startApr 2007
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00456807
Sponsor's protocol ID: 109801
Status last verified: Nov 2016
First submitted: 4 Apr 2007
Last updated: 16 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

All Infections, Papillomavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT00456807
Acronym / sponsor ID: 109801
Conditions: Infections, Papillomavirus
Keywords: Human Papillomavirus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 5 Apr 2007 (estimated)
Results: Posted 30 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Cervarix Group	Experimental	Biological: Cervarix TMSubjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Placebo Group	Placebo comparator	Biological: PlaceboSubjects who received 3 doses of placebo during the primary study (NCT00294047).

Who may qualify

Ages: 26 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboThree doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.	Biological	Placebo Group
Cervarix TMAlso: GSK Biologicals' HPV-16/18 VLP/AS04 vaccineThree doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.	Biological	Cervarix Group

Primary outcome

Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
Time frame: At Month 12 and Month 18 after first vaccination
The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.
Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18
Time frame: At Month 12 and Month 18 after first vaccination
The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells. An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values
Time frame: At Month 12 and Month 18 after first vaccination
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies
Time frame: At Month 12 and Month 18 after first vaccination
Titers are presented as Geometric Mean Titers (GMTs).
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies
Time frame: At Month 12 and Month 18 after first vaccination
Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples
Time frame: At Month 12 and Month 18 after first vaccination
Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.

Results and safety

Results posted to the registry on 30 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cervarix Group	53	52
Placebo Group	47	47

Primary outcome: Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines

Time frame: At Month 12 and Month 18 after first vaccination. Geometric mean (95% Confidence Interval). Unit: cells per million CD4/CD8 T-cells

Measure	Cervarix Group n = 52	Placebo Group n = 47
HPV-16 specific CD4 [Month 12] (n=52,46)	877.4 (665.0 to 1157.7)	19.5 (9.4 to 40.5)
HPV-16 specific CD4 [Month 18] (n=52,47)	738.5 (512.9 to 1063.3)	22.3 (11.3 to 44.0)
HPV-16 specific CD8 [Month 12] (n=52,46)	2.0 (1.3 to 3.1)	2.0 (1.2 to 3.1)
HPV-16 specific CD8 [Month 18] (n=50,47)	2.9 (1.8 to 4.7)	2.7 (1.6 to 4.6)
HPV-18 specific CD4 [Month 12] (n=52,46)	581.2 (428.0 to 789.2)	11.5 (5.7 to 23.4)
HPV-18 specific CD4 [Month 18] (n=52,47)	300.1 (171.9 to 524.1)	16.8 (9.1 to 31.2)
HPV-18 specific CD8 [Month 12] (n=52,46)	2.1 (1.3 to 3.3)	1.8 (1.1 to 2.7)
HPV-18 specific CD8 [Month 18] (n=50,47)	2.8 (1.7 to 4.6)	4.7 (2.6 to 8.7)

Population analysed: Analysis was performed on subjects from the Total Vaccinated Cohort with available results.

Primary outcome: Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18

Time frame: At Month 12 and Month 18 after first vaccination. Geometric mean (95% Confidence Interval). Unit: cells per million B-cells

Measure	Cervarix Group n = 51	Placebo Group n = 45
HPV-16 specific [Month 12] (n=51,44)	517.1 (361.4 to 739.9)	101.4 (45.1 to 227.9)
HPV-16 specific [Month 18] (n=51,45)	304.4 (210.0 to 441.1)	33.1 (6.7 to 163.0)
HPV-18 specific [Month 12] (n=51,44)	354.7 (253.1 to 497.1)	68.4 (27.0 to 173.2)
HPV-18 specific [Month 18] (n=51,45)	301.5 (223.9 to 406.0)	0.0 (0 to 0)

Population analysed: Analysis was performed on subjects from the Total Vaccinated Cohort with available results.

Primary outcome: Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values

Time frame: At Month 12 and Month 18 after first vaccination. Number. Unit: Subjects

Measure	Cervarix Group n = 52	Placebo Group n = 46
Anti-HPV-16 [Month 12] (n=52, 45)	52	14
Anti-HPV-16 [Month 18] (n=49, 46)	49	14
Anti-HPV-18 [Month 12] (n=52, 45)	52	7
Anti-HPV-18 [Month 18] (n=49, 46)	49	7

Population analysed: Analysis was performed on subjects from the Total Vaccinated Cohort with available results.

Primary outcome: Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies

Time frame: At Month 12 and Month 18 after first vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Cervarix Group n = 52	Placebo Group n = 46
Anti-HPV-16 [Month 12] (n=52, 45)	2050.4 (1456.1 to 2887.3)	6.9 (5.3 to 9.0)
Anti-HPV-16 [Month 18] (n=49, 46)	1517.1 (1067.4 to 2156.4)	7.2 (5.4 to 9.5)
Anti-HPV-18 [Month 12] (n=52, 45)	761.4 (538.0 to 1077.5)	4.8 (3.5 to 6.7)
Anti-HPV-18 [Month 18] (n=49, 46)	551.4 (387.5 to 784.6)	4.9 (3.6 to 6.6)

Population analysed: Analysis was performed on subjects from the Total Vaccinated Cohort with available results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	0 of 0	0 of 0	Not reported
Placebo Group	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): No safety data were collected in the framework of this ancillary study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Infections, Papillomavirus

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cervarix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines (time frame: At Month 12 and Month 18 after first vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00456807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.