CompletedNCT00552279Updated Jun 25, 2018Results posted

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age

A Phase 3 interventional study of Cervarix TM and Cervarix TM in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 16 sites in 3 countries. Open to female participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-25.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 805
Allocation: Randomized
Ages: 15 Years to 25 Years
Sex: Female

Study summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions studied

Infections, Papillomavirus

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Keywords

HPV
cervical cancer
papillomavirus
Human papillomavirus (HPV) vaccine

In context

Papillomavirus Infections

505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.

This study's enrollment of 805 is above the median of 202 across 338 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 15 Years to 25 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
A female between and including 15 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
Healthy subjects as established by medical history and/or clinical examination before entering into the study.
Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Subject who had no more than 6 lifetime sexual partners prior to enrolment.

Exclusion criteria

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the patient is outside of specified window.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
previous administration of components of the investigational vaccine
Cancer or autoimmune disease under treatment.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Pregnant or breastfeeding female.
Female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period starting at visit one and up to two months after the last vaccine dose.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or lab tests.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 805 participants (actual)

Study arms

Experimental
Cervarix-12 Group
Women received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule
Biological: Cervarix TM
Active comparator
Cervarix-6 Group
Women received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Biological: Cervarix TM

Interventions

BiologicalCervarix TM
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
Also known as: HPV vaccine (GSK580299)
BiologicalCervarix TM
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

What researchers measure

Primary outcomes

Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
Time frame: One month after the third vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titer given as geometric mean titer (GMT).
Time frame: One month after the third vaccine dose

Secondary outcomes

Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
Time frame: One month after the second vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titer given as GMT.
Time frame: One month after the second vaccine dose
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Time frame: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time frame: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is 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.
Time frame: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)
Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6. NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses. An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the entire study period (up to Month 18 or up to Month 12)
Number of Subjects With Pregnancies and Their Outcomes
Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6 Number of pregnancies and pregnancy outcomes.
Time frame: During the entire study period (up to Month 18 or Month 12)
Number of Subjects Completing the 3-dose Vaccination Schedule
Time frame: After the third vaccine dose

Results

Posted Mar 5, 2010

Participant flow

Participant flow — Overall Study
Milestone	Cervarix-12 Group	Cervarix-6 Group
Started	403	401
Completed	389	398
Not completed	14	3
Withdrew: Adverse event	0	1
Withdrew: Withdrawal by subject	12	1
Withdrew: Lost to follow-up	1	0
Withdrew: Other	1	1

Outcome measures

PrimaryNumber of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.

Time frame:: One month after the third vaccine dose
Reported as:: Count of participants · Participants

Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Participants	Cervarix-12 Group	Cervarix-6 Group
Anti-HPV-16	337	342
Anti-HPV-18	345	346

PrimaryTiter of Anti-HPV-16 and Anti-HPV-18 Antibodies

Titer given as geometric mean titer (GMT).

Time frame:: One month after the third vaccine dose
Reported as:: Geometric mean · EL.U/mL

Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
EL.U/mL	Cervarix-12 Group	Cervarix-6 Group
Anti-HPV-16	11337.2 (10238.2 to 12554.1)	10050.9 (9180.9 to 11003.3)
Anti-HPV-18	4526.7 (4110.1 to 4985.6)	3879.9 (3532.7 to 4261.2)

SecondaryNumber of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies

Time frame:: One month after the second vaccine dose
Reported as:: Count of participants · Participants

Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Participants	Cervarix-12 Group	Cervarix-6 Group
Anti-HPV-16	337	342
Anti-HPV-18	346	346

SecondaryTiter of Anti-HPV-16 and Anti-HPV-18 Antibodies

Titer given as GMT.

Time frame:: One month after the second vaccine dose
Reported as:: Geometric mean · EL.U/mL

Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
EL.U/mL	Cervarix-12 Group	Cervarix-6 Group
Anti-HPV-16	3307.0 (3051.0 to 3584.5)	3184.1 (2938.3 to 3450.5)
Anti-HPV-18	2382.3 (2179.2 to 2604.3)	2256.3 (2070.7 to 2458.7)

SecondaryNumber of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Time frame:: During the 7-day (Days 0-6) period following each vaccination
Reported as:: Count of participants · Participants

Number of Subjects Reporting Solicited Local Symptoms
Participants	Cervarix-12 Group	Cervarix-6 Group
Pain	385	386
Redness	201	182
Swelling	158	145

SecondaryNumber of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.

Time frame:: During the 7-day (Days 0-6) period following each vaccination
Reported as:: Count of participants · Participants

Number of Subjects Reporting Solicited General Symptoms
Participants	Cervarix-12 Group	Cervarix-6 Group
Arthralgia	85	78
Fatigue	245	237
Temperature ≥ 37.5°C	37	29
Gastro-intestinal symptoms	85	86
Headache	203	199
Myalgia	167	168
Rash	30	34
Urticaria	12	18

SecondaryNumber of Subjects Reporting Unsolicited Adverse Events (AE)

An AE is 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.

Time frame:: During the 30-day (Days 0-29) period following each vaccination
Reported as:: Count of participants · Participants

Number of Subjects Reporting Unsolicited Adverse Events (AE)
Participants	Cervarix-12 Group	Cervarix-6 Group
Number of Subjects Reporting Unsolicited Adverse Events (AE)	117	129

SecondaryNumber of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)

Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6. NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses. An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time frame:: During the entire study period (up to Month 18 or up to Month 12)
Reported as:: Count of participants · Participants

Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)
Participants	Cervarix-12 Group	Cervarix-6 Group
MSCs	42	44
NOCDs	0	5
NOADs	0	2
SAEs	12	9

SecondaryNumber of Subjects With Pregnancies and Their Outcomes

Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6 Number of pregnancies and pregnancy outcomes.

Time frame:: During the entire study period (up to Month 18 or Month 12)
Reported as:: Count of participants · Participants

Number of Subjects With Pregnancies and Their Outcomes
Participants	Cervarix-12 Group	Cervarix-6 Group
Normal infant	2	1
Elective abortion	0	2
Abortion threatened	1	0
Ongoing	1	0
Foetal distress syndrome	1	0

SecondaryNumber of Subjects Completing the 3-dose Vaccination Schedule

Time frame:: After the third vaccine dose
Reported as:: Count of participants · Participants

Number of Subjects Completing the 3-dose Vaccination Schedule
Participants	Cervarix-12 Group	Cervarix-6 Group
Number of Subjects Completing the 3-dose Vaccination Schedule	388	397

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cervarix-12 Group	—	12/403 (3%)	388/403 (96.3%)
Cervarix-6 Group	—	9/401 (2.2%)	389/401 (97%)

Most frequent serious events

Showing 10 of 24

Most frequent serious events
Event	Cervarix-12 Group	Cervarix-6 Group
AppendicitisInfections and infestations	2/403	1/401
Abdominal painGastrointestinal disorders	2/403	0/401
Breast cancer femaleNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/403	1/401
ChondropathyMusculoskeletal and connective tissue disorders	0/403	1/401
GastroenteritisInfections and infestations	0/403	1/401
Road traffic accidentInjury, poisoning and procedural complications	0/403	1/401
ThyroiditisEndocrine disorders	0/403	1/401
Urinary tract infectionInfections and infestations	1/403	1/401
VertigoEar and labyrinth disorders	0/403	1/401
UrticariaSkin and subcutaneous tissue disorders	0/403	1/401

Most frequent other events

Most frequent other events
Event	Cervarix-12 Group	Cervarix-6 Group
PainGeneral disorders	385/403	386/401
FatigueGeneral disorders	245/403	237/401
HeadacheGeneral disorders	203/403	199/401
RednessGeneral disorders	201/403	182/401
MyalgiaGeneral disorders	167/403	168/401
SwellingGeneral disorders	158/403	145/401
Gastrointestinal symptomsGeneral disorders	85/403	86/401
ArthralgiaGeneral disorders	85/403	78/401
Temperature ≥ 37.5°CGeneral disorders	37/403	29/401
RashGeneral disorders	30/403	34/401

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Cervarix-12 Group	Cervarix-6 Group	Total
Mean	18.6 ± 2.98	18.7 ± 3.13	18.6 ± 3.05

Sex: Female, Male
Sex: Female, Male(Participants)	Cervarix-12 Group	Cervarix-6 Group	Total
Female	403	401	804
Male	0	0	0

Study locations

16 sites

GSK Investigational Site
Brescia, Lombardy 25123, Italy
GSK Investigational Site
Lodi, Lombardy 26900, Italy
GSK Investigational Site
Milan, Lombardy 20122, Italy
GSK Investigational Site
Cagliari, Sardinia 09127, Italy
GSK Investigational Site
Sassari, Sardinia 07100, Italy
GSK Investigational Site
Palermo, Sicily 90127, Italy
GSK Investigational Site
Ragusa, Sicily 97100, Italy
GSK Investigational Site
Bucharest, 010507, Romania
GSK Investigational Site
Bucharest, 077190, Romania
GSK Investigational Site
Bucharest, 22102, Romania
GSK Investigational Site
Cluj-Napoca, 400217, Romania
GSK Investigational Site
Sibiu, 550245, Romania
GSK Investigational Site
Sibiu, Romania
GSK Investigational Site
Dolný Kubín, 026 01, Slovakia
GSK Investigational Site
Nová Dubnica, 018 51, Slovakia
GSK Investigational Site
Trenčín, 911 01, Slovakia

References and documents

Publications

Esposito S, Birlutiu V, Jarcuska P, Perino A, Man SC, Vladareanu R, Meric D, Dobbelaere K, Thomas F, Descamps D. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. Pediatr Infect Dis J. 2011 Mar;30(3):e49-55. doi: 10.1097/INF.0b013e318206c26e. PubMed 21273939 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Feb 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2010, 1 year after primary completion. A results delay was requested in Aug 2009.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 30, 2007
First posted: Nov 1, 2007
Start: Nov 12, 2007
Primary completionActual: Feb 26, 2009
CompletionActual: Jul 20, 2009
Results delay requested: Aug 19, 2009
Results first posted: Mar 5, 2010
Last update: Jun 25, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00552279
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Nov 1, 2007
Start date: Nov 12, 2007
Primary completion: Feb 26, 2009
Completion: Jul 20, 2009
Results posted: Mar 5, 2010
Last update: Jun 25, 2018

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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