Infections, PapillomavirusPhase 2NCT00359619

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

A Phase 2 study testing CervarixTM and HPV investigational vaccine GSK568893A, different formulations in people with Infections, Papillomavirus and Papillomavirus Vaccines, run by GlaxoSmithKline at 10 sites in 2 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?: CervarixTM and HPV investigational vaccine GSK568893A, different formulations
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 383 participants
Where: 10 sitesin 2 countries
Study dates: 12 Sep 2006to 30 Jan 2007
Phase: Phase 2
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 who enrolled in the study 102115 and received three doses of vaccine.
Written informed consent obtained from the subject prior to enrolment.

Who cannot join

Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

Belgium6 sites

GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Tienen, 3300
GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

United States4 sites

GSK Investigational Site
Denver, Colorado, 80262
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121

Other trials in United States

About this study

Official title: A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study

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. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

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

Conditions: Infections, Papillomavirus, Papillomavirus Vaccines
Being tested: CervarixTM, HPV investigational vaccine GSK568893A, different formulations
Keywords: HPV vaccine
Medical subject headings: Papillomavirus Infections

What participants receive

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

CervarixTMBiological
Subjects were administered three doses of HPV vaccine
HPV investigational vaccine GSK568893A, different formulationsBiological
Subjects were administered three doses of HPV investigational vaccine

Study groups in NCT00359619
Study group	Role	What they receive
Cervarix Group	Active comparator	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: CervarixTM
Cervarix 1 Group	Experimental	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 2 Group	Experimental	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 3 Group	Experimental	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 4 Group	Experimental	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 5 Group	Experimental	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 6 Group	Experimental	Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: HPV investigational vaccine GSK568893A, different formulations

What is being measured

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

Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Measured: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.

Secondary outcomes (11)

Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Measured: At Months 18, 24, 36 and 48.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)
Measured: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
Measured: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.
Measured: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
Measured: From Month 0 to Month 18
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
Measured: From Month 0 to Month 24
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
Measured: From Month 0 to Month 36
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
Measured: From Month 0 to Month 48

Timeline

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

12 Sep 200630 Jan 2007

First posted2 Aug 2006 (estimated)
Study start12 Sep 2006
Primary completion30 Jan 2007
Study completion30 Jan 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.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00359619
Sponsor's protocol ID: 108052 (FU month 18)
Other IDs: 107919, 107921, 107918, 2004-003766-14, 2004
Status last verified: Dec 2019
First submitted: 18 Jul 2006
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)

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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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: A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
ClinicalTrials.gov ID: NCT00359619
Acronym / sponsor ID: 108052 (FU month 18)
Conditions: Infections, Papillomavirus, Papillomavirus Vaccines
Keywords: HPV vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 12 Sep 2006 (actual)
Primary completion: 30 Jan 2007 (actual)
Study completion: 30 Jan 2007 (actual)
First posted: 2 Aug 2006 (estimated)
Results: Posted 10 Feb 2015

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: None (open label)
Number of arms: 7

Arm	Type	Receives
Cervarix Group	Active comparator	Biological: CervarixTMFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 1 Group	Experimental	Biological: HPV investigational vaccine GSK568893A, different formulationsFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 2 Group	Experimental	Biological: HPV investigational vaccine GSK568893A, different formulationsFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 3 Group	Experimental	Biological: HPV investigational vaccine GSK568893A, different formulationsFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 4 Group	Experimental	Biological: HPV investigational vaccine GSK568893A, different formulationsFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 5 Group	Experimental	Biological: HPV investigational vaccine GSK568893A, different formulationsFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Cervarix 6 Group	Experimental	Biological: HPV investigational vaccine GSK568893A, different formulationsFemale subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly 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 (2 listed)

A female who enrolled in the study 102115 and received three doses of vaccine.
Written informed consent obtained from the subject prior to enrolment.

Key exclusion criteria (4 listed)

Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

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
CervarixTMSubjects were administered three doses of HPV vaccine	Biological	Cervarix Group
HPV investigational vaccine GSK568893A, different formulationsSubjects were administered three doses of HPV investigational vaccine	Biological	Cervarix 1 Group, Cervarix 2 Group, Cervarix 3 Group, Cervarix 4 Group, Cervarix 5 Group, Cervarix 6 Group

Primary outcome

Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Time frame: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Time frame: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.

11 secondary outcomes

Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Time frame: At Months 18, 24, 36 and 48.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With at Least One Medically Significant Condition (MAEs).
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Pregnancy Outcomes.
Time frame: From Month 0 to Month 18
Number of Subjects With Pregnancy Outcomes.
Time frame: From Month 0 to Month 24
Number of Subjects With Pregnancy Outcomes.
Time frame: From Month 0 to Month 36
Number of Subjects With Pregnancy Outcomes.
Time frame: From Month 0 to Month 48

Results and safety

Results posted to the registry on 10 Feb 2015, 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	88	80
Cervarix 1 Group	50	45
Cervarix 2 Group	49	42
Cervarix 3 Group	48	45
Cervarix 4 Group	48	45
Cervarix 5 Group	50	45
Cervarix 6 Group	50	46

Primary outcome: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.

Time frame: At Months 18, 24, 36 and 48.. Number. Unit: subjects

Measure	Cervarix Group n = 28	Cervarix 1 Group n = 12	Cervarix 2 Group n = 11	Cervarix 3 Group n = 9	Cervarix 4 Group n = 16	Cervarix 5 Group n = 15	Cervarix 6 Group n = 15
Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	27	10	9	8	14	13	13
Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	28	12	11	9	16	15	15
Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	28	12	11	9	16	15	15
Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	28	12	11	9	16	15	15

Population analysed: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.

Time frame: At Months 18, 24, 36 and 48.. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Cervarix Group n = 28	Cervarix 1 Group n = 12	Cervarix 2 Group n = 11	Cervarix 3 Group n = 9	Cervarix 4 Group n = 16	Cervarix 5 Group n = 15	Cervarix 6 Group n = 15
Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1933.9 (1318.0 to 2837.5)	1868.3 (1263.0 to 2763.8)	1902.3 (603.5 to 5996.7)	1996.4 (1017.8 to 3915.8)	1437.1 (777.3 to 2657.0)	2200.3 (1284.4 to 3769.4)	1769.8 (914.9 to 3423.7)
Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1477.1 (1039.3 to 2099.3)	1381.6 (942.1 to 2026.4)	1339.9 (553.1 to 3246.1)	1520.6 (916.6 to 2522.5)	1264.4 (718.8 to 2224.0)	1817.8 (1194.5 to 2766.4)	1585.6 (952.0 to 2640.9)
Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1296.8 (917.1 to 1833.6)	1200.5 (814.8 to 1768.9)	1023.1 (389.2 to 2689.8)	1275.3 (780.2 to 2084.7)	960.6 (555.6 to 1660.7)	1521.8 (943.4 to 2454.8)	1076.9 (619.0 to 1873.6)
Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1300.9 (952.3 to 1777.1)	1115.4 (780.3 to 1594.3)	1007.5 (361.3 to 2809.6)	1337.7 (755.4 to 2368.9)	1070.8 (614.6 to 1865.7)	1417.8 (882.0 to 2279.0)	1105.5 (620.6 to 1969.3)

Primary outcome: Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies

Time frame: At Months 18, 24, 36 and 48.. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Cervarix Group n = 33	Cervarix 1 Group n = 18	Cervarix 2 Group n = 16	Cervarix 3 Group n = 18	Cervarix 4 Group n = 18	Cervarix 5 Group n = 20	Cervarix 6 Group n = 19
Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1902.6 (1309.3 to 2764.7)	1558.5 (1122.9 to 2163.2)	1791.7 (823.6 to 3897.7)	1552.9 (981.6 to 2456.5)	1242.8 (687.3 to 2247.4)	1869.6 (1161.1 to 3010.5)	1764.4 (1073.8 to 2899.2)
Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1472.8 (1046.2 to 2073.3)	1223.4 (911.2 to 1642.6)	1347.4 (740.7 to 2451.1)	1579.5 (1053.9 to 2367.2)	1092.8 (626.2 to 1907.2)	1672.2 (1130.2 to 2474.1)	1130.2 (1130.2 to 2367.2)
Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1291.7 (928.4 to 1797.1)	1031.2 (764.2 to 1391.5)	1032.9 (538.9 to 1979.5)	1107.7 (776.4 to 1580.3)	841.4 (495.4 to 1428.9)	1381.9 (901.0 to 2119.3)	1128.6 (728.5 to 1748.3)
Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	1248.8 (907.1 to 1719.1)	955.5 (722.7 to 1263.1)	1104.9 (556.9 to 2192.1)	1097.4 (737.8 to 1632.4)	911.3 (526.5 to 1577.4)	1310.1 (862.8 to 1989.2)	1150.4 (727.8 to 1818.3)

Primary outcome: Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.

Time frame: At Months 18, 24, 36 and 48.. Number. Unit: subjects

Measure	Cervarix Group n = 26	Cervarix 1 Group n = 13	Cervarix 2 Group n = 14	Cervarix 3 Group n = 18	Cervarix 4 Group n = 12	Cervarix 5 Group n = 18	Cervarix 6 Group n = 17
Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	26	10	12	16	11	15	15
Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	26	13	14	18	12	18	17
Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	26	13	14	18	12	18	17
Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	26	13	14	18	12	18	17

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	6 of 88 (6.8%)	0 of 0	Not reported
Cervarix 1 Group	4 of 50 (8%)	0 of 0	Not reported
Cervarix 2 Group	2 of 49 (4.1%)	0 of 0	Not reported
Cervarix 3 Group	6 of 48 (12.5%)	0 of 0	Not reported
Cervarix 4 Group	3 of 48 (6.3%)	0 of 0	Not reported
Cervarix 5 Group	1 of 50 (2%)	0 of 0	Not reported
Cervarix 6 Group	1 of 50 (2%)	0 of 0	Not 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.
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

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 10 sites in Belgium, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 10 Feb 2015). 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 Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies. (time frame: At Months 18, 24, 36 and 48.). 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 NCT00359619.

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.