Infections, PapillomavirusPhase 3NCT00250276

Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

A Phase 3 study testing Cervarix™ in people with Infections, Papillomavirus and Papillomavirus Vaccines, run by GlaxoSmithKline at 8 sites in 3 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus, Papillomavirus Vaccines
What is being tested?: Cervarix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 798 participants
Where: 8 sitesin 3 countries
Study dates: 28 Oct 2005to 1 Mar 2007
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 18 to 25 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment.
Subject must have a negative urine pregnancy test.
Healthy subject before entering the study entry as established by medical history and physical examination.
Subject must be of non-childbearing potential.

Who cannot join

pregnant or breastfeeding subject.
previous vaccination against human papillomavirus (HPV).
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Lithuania4 sites

GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Klaipėda, LT-93200
GSK Investigational Site
Vilnius, LT-07156
GSK Investigational Site
Vilnius, LT-10207

Other trials in Lithuania

Poland3 sites

GSK Investigational Site
Krakow, 31-501
GSK Investigational Site
Poznan, 60-533
GSK Investigational Site
Warsaw, 01-211

Other trials in Poland

Denmark1 site

GSK Investigational Site
Hvidovre, DK-2650

Other trials in Denmark

About this study

Official title: Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

Conditions: Infections, Papillomavirus, Papillomavirus Vaccines
Being tested: Cervarix™
Medical subject headings: Papillomavirus Infections

What participants receive

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

Cervarix™Biological
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Study groups in NCT00250276
Study group	Role	What they receive
Cervarix Lot1 Group	Experimental	Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Receives: Biological: Cervarix™
Cervarix Lot2 Group	Experimental	Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Receives: Biological: Cervarix™
Cervarix Lot3 Group	Experimental	Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Receives: Biological: Cervarix™
Cervarix Low Group	Experimental	Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Receives: Biological: Cervarix™

What is being measured

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

Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Measured: At Month 7
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Measured: At Month 7

Secondary outcomes (14)

Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Measured: At Month 2
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .
Measured: At Month 2
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.
Measured: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.
Measured: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.
Measured: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.
Measured: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.
Measured: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From Month 0 to Month 7
Number of Subjects With Medically Significant Adverse Events (MSAEs)
MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: From Month 0 to Month 7
Number of Subjects With (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From Month 0 to Month 12
Number of Subjects With MSAEs
MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: From Month 0 to Month 12
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: Within 30 days (Day 0-29) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 0 to Month 7
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 0 to Month 12

Timeline

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

28 Oct 20051 Mar 2007

First posted8 Nov 2005 (estimated)
Study start28 Oct 2005
Primary completion1 Mar 2007
Study completion1 Mar 2007

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.
Publications (1)Papers the sponsor has linked to this study.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 798 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00250276
Sponsor's protocol ID: 104772
Other IDs: 2005-001667-58, 2005
Status last verified: Dec 2019
First submitted: 7 Nov 2005
Last updated: 2 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.
PubMed 19221517

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

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Human Papillomavirus Infection
Active, not recruitingPhase 4
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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 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)
ClinicalTrials.gov ID: NCT00250276
Acronym / sponsor ID: 104772
Conditions: Infections, Papillomavirus, Papillomavirus Vaccines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 798 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Oct 2005 (actual)
Primary completion: 1 Mar 2007 (actual)
Study completion: 1 Mar 2007 (actual)
First posted: 8 Nov 2005 (estimated)
Results: Posted 17 Mar 2017

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Cervarix Lot1 Group	Experimental	Biological: Cervarix™Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Lot2 Group	Experimental	Biological: Cervarix™Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Lot3 Group	Experimental	Biological: Cervarix™Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Low Group	Experimental	Biological: Cervarix™Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Who may qualify

Ages: 18 to 25 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment.
Subject must have a negative urine pregnancy test.
Healthy subject before entering the study entry as established by medical history and physical examination.
Subject must be of non-childbearing potential.

Key exclusion criteria (4 listed)

pregnant or breastfeeding subject.
previous vaccination against human papillomavirus (HPV).
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.

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
Cervarix™GSK Biologicals' vaccine against human papillomaviruses 16 and 18.	Biological	Cervarix Lot1 Group, Cervarix Lot2 Group, Cervarix Lot3 Group, Cervarix Low Group

Primary outcome

Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
Time frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Time frame: At Month 7
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.

14 secondary outcomes

Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18
Time frame: At Month 2
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Time frame: At Month 2
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-days (Day 0-6) post-vaccination
Number of Subjects With New Onset Chronic Diseases (NOCDs)
Time frame: From Month 0 to Month 7
Number of Subjects With Medically Significant Adverse Events (MSAEs)
Time frame: From Month 0 to Month 7
Number of Subjects With (NOCDs)
Time frame: From Month 0 to Month 12
Number of Subjects With MSAEs
Time frame: From Month 0 to Month 12
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within 30 days (Day 0-29) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 7
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 12

Results and safety

Results posted to the registry on 17 Mar 2017, 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 Lot1 Group	199	182
Cervarix Lot2 Group	198	177
Cervarix Lot3 Group	201	182
Cervarix Low Group	200	181

Primary outcome: Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)

Time frame: At Month 7. Count of participants. Unit: Participants

Measure	Cervarix Lot1 Group n = 129	Cervarix Lot2 Group n = 143	Cervarix Lot3 Group n = 135	Pooled Group n = 407	Cervarix Low Group n = 117
Anti-HPV-16	118	127	126	371	102
Anti-HPV-18	129	143	135	407	117

Cervarix Lot1 Group vs Cervarix Lot2 Group: GMC ratio for anti-HPV-16 antibody: 1.04 (95% CI 0.81 to 1.34), ANOVA
Cervarix Lot1 Group vs Cervarix Lot2 Group: GMC ratio for anti-HPV-18 antibody: 1.19 (95% CI 0.95 to 1.49), ANOVA
Cervarix Lot1 Group vs Cervarix Lot3 Group: GMC ratio for anti-HPV-16 antibody: 1.26 (95% CI 0.98 to 1.63), ANOVA

Population analysed: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.

Primary outcome: Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18

Time frame: At Month 7. Count of participants. Unit: Participants

Measure	Cervarix Lot1 Group n = 54	Cervarix Lot2 Group n = 38	Cervarix Lot3 Group n = 43	Cervarix Low Group n = 57
Anti-HPV-16	54	38	43	57
Anti-HPV-18	43	22	34	41

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).. Other adverse events reported at 4.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Lot1 Group	6 of 199 (3%)	196 of 199 (98.5%)	Not reported
Cervarix Lot2 Group	1 of 198 (0.5%)	194 of 198 (98%)	Not reported
Cervarix Lot3 Group	2 of 201 (1%)	191 of 201 (95%)	Not reported
Pooled Group	9 of 598 (1.5%)	581 of 598 (97.2%)	Not reported
Cervarix Low Group	3 of 200 (1.5%)	194 of 200 (97%)	Not reported

Limitations and caveats (from the sponsor): None reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19221517Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.
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. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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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

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cervarix™ in people with Infections, Papillomavirus and Papillomavirus Vaccines, run by GlaxoSmithKline at 8 sites in 3 countries.

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 5 inclusion and 4 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Lithuania, Poland, Denmark. 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. 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 17 Mar 2017). 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 Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) (time frame: At Month 7). The study lists 2 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 NCT00250276, which also lists 1 linked publication.

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 2 Jan 2020.