Infections, PapillomavirusPhase 2NCT00231413

Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

A Phase 2 study testing HPV 16/18 L1 AS04, HPV-16/18/31/45 L1 AS04 Formulation 1 and HPV-16/18/31/45 L1 AS04 Formulation 2 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 11 sites in 2 countries.

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 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: HPV 16/18 L1 AS04, HPV-16/18/31/45 L1 AS04 Formulation 1 and HPV-16/18/31/45 L1 AS04 Formulation 2
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 383 participants
Where: 11 sitesin 2 countries
Study dates: 4 Mar 2005to 27 Mar 2006
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 woman between, and including, 18 and 25 years of age at the time of the first vaccination
Written informed consent from the subject prior to enrolment
Subject must be free of obvious health problems
Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Who cannot join

Pregnant or breastfeeding
A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
Previous vaccination against human papillomavirus (HPV)

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 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
Roeselare, 8800
GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

United States5 sites

GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Kingston, Rhode Island, 02881
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 Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

Conditions: Infections, Papillomavirus
Being tested: HPV 16/18 L1 AS04, HPV-16/18/31/45 L1 AS04 Formulation 1, HPV-16/18/31/45 L1 AS04 Formulation 2, HPV-16/18/31/45 L1 AS04 Formulation 3, HPV-16/18/31/45 L1 AS04 Formulation 4
Medical subject headings: Papillomavirus Infections

What participants receive

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

HPV 16/18 L1 AS04Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
HPV-16/18/31/45 L1 AS04 Formulation 1Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
HPV-16/18/31/45 L1 AS04 Formulation 2Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
HPV-16/18/31/45 L1 AS04 Formulation 3Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
HPV-16/18/31/45 L1 AS04 Formulation 4Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
HPV-16/18/31/45 L1 AS04 Formulation 5Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
HPV-16/18/31/45 L1 AS04 Formulation 6Biological
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

Study groups in NCT00231413
Study group	Role	What they receive
HPV-16/18 Group	Active comparator	Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV 16/18 L1 AS04
HPV-TETRA A Group	Experimental	Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV-16/18/31/45 L1 AS04 Formulation 1
HPV-TETRA B Group	Experimental	Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV-16/18/31/45 L1 AS04 Formulation 2
HPV-TETRA C Group	Experimental	Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV-16/18/31/45 L1 AS04 Formulation 3
HPV-TETRA D Group	Experimental	Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV-16/18/31/45 L1 AS04 Formulation 4
HPV-TETRA E Group	Experimental	Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV-16/18/31/45 L1 AS04 Formulation 5
HPV-TETRA F Group	Experimental	Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. Receives: Biological: HPV-16/18/31/45 L1 AS04 Formulation 6

What is being measured

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

Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Month 7
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Measured: At Month 7
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Measured: At Month 7
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Measured: At Month 7

Secondary outcomes (17)

Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.
Measured: At Month 2
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Measured: At Month 2
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Measured: At Month 2
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Measured: At Month 2
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
Measured: At Month 2 and Month 7
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
Measured: At Month 2 and Month 7
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Measured: At Month 2 and Month 7
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Measured: At Month 2 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.
Measured: During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Measured: During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.
Measured: During the 30-day post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Measured: From Day 0 to Month 7
Number of Subjects With Any SAEs During the Extended Safety Follow-up
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Measured: From Day 0 to Month 12
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
Measured: From Day 0 to Month 12
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
Measured: From Day 0 up to Month 12
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
Measured: From Day 0 up to Month 12
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological [basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.
Measured: At Month 2 and Month 7

Timeline

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

4 Mar 200527 Mar 2006

First posted4 Oct 2005 (estimated)
Study start4 Mar 2005
Primary completion27 Mar 2006
Study completion27 Mar 2006

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00231413
Sponsor's protocol ID: 102115
Other IDs: 2004-003766-14, 2004
Status last verified: Nov 2019
First submitted: 3 Oct 2005
Last updated: 12 Dec 2019
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

Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.
PubMed 24674663

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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)
ClinicalTrials.gov ID: NCT00231413
Acronym / sponsor ID: 102115
Conditions: Infections, Papillomavirus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Mar 2005 (actual)
Primary completion: 27 Mar 2006 (actual)
Study completion: 27 Mar 2006 (actual)
First posted: 4 Oct 2005 (estimated)
Results: Posted 12 Dec 2019

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: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
HPV-16/18 Group	Active comparator	Biological: HPV 16/18 L1 AS04Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
HPV-TETRA A Group	Experimental	Biological: HPV-16/18/31/45 L1 AS04 Formulation 1Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
HPV-TETRA B Group	Experimental	Biological: HPV-16/18/31/45 L1 AS04 Formulation 2Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
HPV-TETRA C Group	Experimental	Biological: HPV-16/18/31/45 L1 AS04 Formulation 3Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
HPV-TETRA D Group	Experimental	Biological: HPV-16/18/31/45 L1 AS04 Formulation 4Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
HPV-TETRA E Group	Experimental	Biological: HPV-16/18/31/45 L1 AS04 Formulation 5Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
HPV-TETRA F Group	Experimental	Biological: HPV-16/18/31/45 L1 AS04 Formulation 6Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.

Who may qualify

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

Key inclusion criteria (4 listed)

A woman between, and including, 18 and 25 years of age at the time of the first vaccination
Written informed consent from the subject prior to enrolment
Subject must be free of obvious health problems
Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Key exclusion criteria (5 listed)

Pregnant or breastfeeding
A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
Previous vaccination against human papillomavirus (HPV)

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
HPV 16/18 L1 AS043 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-16/18 Group
HPV-16/18/31/45 L1 AS04 Formulation 13 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-TETRA A Group
HPV-16/18/31/45 L1 AS04 Formulation 23 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-TETRA B Group
HPV-16/18/31/45 L1 AS04 Formulation 33 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-TETRA C Group
HPV-16/18/31/45 L1 AS04 Formulation 43 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-TETRA D Group
HPV-16/18/31/45 L1 AS04 Formulation 53 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-TETRA E Group
HPV-16/18/31/45 L1 AS04 Formulation 63 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.	Biological	HPV-TETRA F Group

Primary outcome

Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Time frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
Time frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
Time frame: At Month 7
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
Time frame: At Month 7
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.

17 secondary outcomes

Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
Time frame: At Month 2
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
Time frame: At Month 2
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
Time frame: At Month 2
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
Time frame: At Month 2
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Time frame: At Month 2 and Month 7
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Time frame: At Month 2 and Month 7
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Time frame: At Month 2 and Month 7
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Time frame: At Month 2 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 30-day post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: From Day 0 to Month 7
Number of Subjects With Any SAEs During the Extended Safety Follow-up
Time frame: From Day 0 to Month 12
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Time frame: From Day 0 to Month 12
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Time frame: From Day 0 up to Month 12
Number of Subjects Reporting Medically Significant Conditions
Time frame: From Day 0 up to Month 12
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Time frame: At Month 2 and Month 7

Results and safety

Results posted to the registry on 12 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HPV-16/18 Group	88	80
HPV-TETRA A Group	50	45
HPV-TETRA B Group	49	42
HPV-TETRA C Group	48	45
HPV-TETRA D Group	48	45
HPV-TETRA E Group	50	45
HPV-TETRA F Group	50	46

Primary outcome: Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7

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

Measure	HPV-16/18 Group n = 62	HPV-TETRA A Group n = 32	HPV-TETRA B Group n = 31	HPV-TETRA C Group n = 23	HPV-TETRA D Group n = 33	HPV-TETRA E Group n = 28	HPV-TETRA F Group n = 33
Value	62	27	31	23	33	28	33

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Number of Seroconverted Subjects for Anti-HPV-18 at Month 7

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

Measure	HPV-16/18 Group n = 59	HPV-TETRA A Group n = 30	HPV-TETRA B Group n = 37	HPV-TETRA C Group n = 34	HPV-TETRA D Group n = 27	HPV-TETRA E Group n = 33	HPV-TETRA F Group n = 36
Value	59	30	37	34	27	33	36

Population analysed: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7

Time frame: At Month 7. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	HPV-16/18 Group n = 62	HPV-TETRA A Group n = 27	HPV-TETRA B Group n = 31	HPV-TETRA C Group n = 23	HPV-TETRA D Group n = 33	HPV-TETRA E Group n = 28	HPV-TETRA F Group n = 33
Value	9086.1 (7231.1 to 11417.1)	5757.4 (4283.9 to 7737.8)	7897.7 (5825.2 to 10707.6)	7524.1 (5678.1 to 9970.2)	5986.4 (4485.2 to 7990.2)	8483.5 (6257.6 to 11501.1)	7605.0 (5818.7 to 9939.6)

Primary outcome: Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7

Time frame: At Month 7. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	HPV-16/18 Group n = 59	HPV-TETRA A Group n = 30	HPV-TETRA B Group n = 37	HPV-TETRA C Group n = 34	HPV-TETRA D Group n = 27	HPV-TETRA E Group n = 33	HPV-TETRA F Group n = 36
Value	5184.5 (4211.1 to 6382.8)	3061.3 (2231.7 to 4199.4)	3640.2 (2590.4 to 5115.6)	3268.6 (2650.4 to 4031.1)	2998.5 (2109.5 to 4262.1)	3296.2 (2402.8 to 4521.8)	3056.0 (2364.5 to 3949.5)

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HPV-16/18 Group	2 of 88 (2.3%)	81 of 88 (92%)	0 of 88
HPV-TETRA A Group	2 of 50 (4%)	48 of 50 (96%)	0 of 50
HPV-TETRA B Group	1 of 49 (2%)	46 of 49 (93.9%)	0 of 49
HPV-TETRA C Group	3 of 48 (6.3%)	45 of 48 (93.8%)	0 of 48
HPV-TETRA D Group	2 of 48 (4.2%)	44 of 48 (91.7%)	0 of 48
HPV-TETRA E Group	0 of 50 (0%)	50 of 50 (100%)	0 of 50
HPV-TETRA F Group	0 of 50 (0%)	47 of 50 (94%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24674663Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.
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).

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

11 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 4 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 12 Dec 2019). 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 for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 (time frame: At Month 7). The study lists 4 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 NCT00231413, 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 12 Dec 2019.