AzTrials
AzTrials

Infections, PapillomavirusPhase 3NCT00122681

Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

A Phase 3 study testing Cervarix™ and Havrix™-based investigational formulation in people with Infections, Papillomavirus, run by GlaxoSmithKline at 138 sites in 14 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

Human Papilloma virus (HPV) are viruses that cause a common infection 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). Read more about this study

Who is it for?
Ages 15 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
Cervarix™ and Havrix™-based investigational formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,729 participants
Where
138 sitesin 14 countries
Study dates
6 May 2004to 26 Nov 2009
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 15 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
  • A woman between, and including, 15 and 25 years of age at the time of the first vaccination.
  • Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent).
  • Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Subject must have a negative urine pregnancy test.
  • Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
  • Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements.
  • Subject must have intact cervix.

Who cannot join

  • Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
  • A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8).
  • Previous administration of components of the investigational vaccine.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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 (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
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  • Previous vaccination against human papillomavirus (HPV).
  • History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease.
  • History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
  • Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
  • Hypersensitivity to latex.
  • Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
  • History of chronic condition(s) requiring treatment.
  • Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window.
  • Acute disease at the time of enrolment.
  • Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.

Trial locations and contacts

138 sites in 14 countries.

138 sites in 14 countries

United States50 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Arkansas City, Kansas, 67005

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Birmingham, Alabama, 35233

  • GSK Investigational Site

    Boulder, Colorado, 80303

  • GSK Investigational Site

    Boulder, Colorado, 80304

  • GSK Investigational Site

    Carnegie, Pennsylvania, 15106

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27514

  • GSK Investigational Site

    Charlottesville, Virginia, 22903

  • GSK Investigational Site

    Clearwater, Florida, 33759

  • GSK Investigational Site

    Cleveland, Ohio, 44109

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Denver, Colorado, 80218

  • GSK Investigational Site

    Erie, Pennsylvania, 16502

  • GSK Investigational Site

    Erie, Pennsylvania, 16505

  • GSK Investigational Site

    Erie, Pennsylvania, 16507

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Honolulu, Hawaii, 96826

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Louisville, Colorado, 80027

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    Morristown, New Jersey, 07960

  • GSK Investigational Site

    New Bern, North Carolina, 28562

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19114

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Poughkeepsie, New York, 12601

  • GSK Investigational Site

    Salt Lake City, Utah, 84120

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    Spokane, Washington, 99202

  • GSK Investigational Site

    Spokane, Washington, 99218

  • GSK Investigational Site

    Tulsa, Oklahoma, 74105

  • GSK Investigational Site

    Vancouver, Washington, 98664

  • GSK Investigational Site

    Webster, Texas, 77598

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

Finland19 sites

  • GSK Investigational Site

    Espoo, 02100

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Helsinki, 00610

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Jyväskylä, 40100

  • GSK Investigational Site

    Kerava, 04250

  • GSK Investigational Site

    Kotka, 48100

  • GSK Investigational Site

    Kouvola, 45100

  • GSK Investigational Site

    Kuopio, 70100

  • GSK Investigational Site

    Lahti, 15110

  • GSK Investigational Site

    Lappeenranta, 53100

  • GSK Investigational Site

    Mikkeli, 50100

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Pori, 28100

  • GSK Investigational Site

    Rauma, 26100

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

  • GSK Investigational Site

    Vaasa, 65100

Other trials in Finland

Germany19 sites

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Dietzenbach, Hesse, 63128

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60439

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 65936

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hamburg, 22149

  • GSK Investigational Site

    Hamburg, 22159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30657

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76199

  • GSK Investigational Site

    Leipzig, Saxony, 04109

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Munich, Bavaria, 80637

  • GSK Investigational Site

    Nordhausen, Thuringia, 99734

  • GSK Investigational Site

    Ravensburg, Baden-Wurttemberg, 88212

  • GSK Investigational Site

    Rheinstetten, Baden-Wurttemberg, 76287

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

Canada11 sites

  • GSK Investigational Site

    Beauport, Quebec, G1E 7G9

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2C8

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Oshawa, Ontario, L1H 1C2

  • GSK Investigational Site

    Ottawa, Ontario, K1S 1C2

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Waterloo, Ontario, N2J 1C4

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0J9

Other trials in Canada

Australia6 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Carlton, Melbourne, Victoria

  • GSK Investigational Site

    Hobart, Tasmania

  • GSK Investigational Site

    Melbourne, Victoria

  • GSK Investigational Site

    Perth, Western Australia

  • GSK Investigational Site

    Sydney, New South Wales, 4001

Other trials in Australia

Philippines6 sites

  • GSK Investigational Site

    Cavite

  • GSK Investigational Site

    Laguna

  • GSK Investigational Site

    Las Piñas

  • GSK Investigational Site

    Los Banos, Laguna, 4027

  • GSK Investigational Site

    Makati City, 1231

  • GSK Investigational Site

    Manila, 1000

Other trials in Philippines

Spain6 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    Madrid, 28009

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Móstoles, 28935

Other trials in Spain

United Kingdom6 sites

  • GSK Investigational Site

    Aberdeen, AB25 2ZN

  • GSK Investigational Site

    London, SW17 0QT

  • GSK Investigational Site

    London, W1P 1LB

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Manchester, M15 6SX

  • GSK Investigational Site

    Waterloo, Liverpool, L22 0LG

Other trials in United Kingdom

Belgium3 sites

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

Brazil3 sites

  • GSK Investigational Site

    Campinas, São Paulo

  • GSK Investigational Site

    Curitiba, Paraná, 80069-900

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

Taiwan3 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taipei, 114

Other trials in Taiwan

Thailand3 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

Other trials in Thailand

Italy2 sites

  • GSK Investigational Site

    Milan, Lombardy, 20122

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41150

Other trials in Italy

Mexico1 site

  • GSK Investigational Site

    Cuenavaca, Morelos, 62430

Other trials in Mexico

About this study

Official title: A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.

Human Papilloma virus (HPV) are viruses that cause a common infection 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 often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

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

Read the detailed description

NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request.

Being tested
Cervarix™, Havrix™-based investigational formulation
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

    Also called GSK Biologicals HPV 16/18 VLP/AS04 vaccine

    Intramuscular injection, 3 doses

  • Havrix™-based investigational formulationBiological

    Intramuscular injection, 3 doses

Study groups in NCT00122681
Study groupRoleWhat they receive
Cervarix GroupExperimentalSubjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Receives: Biological: Cervarix™
Havrix GroupActive comparatorSubjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Receives: Biological: Havrix™-based investigational formulation

What is being measured

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

  1. Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)

    CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.

    Detection was done in:

    1. DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
    2. Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3

  2. Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)

    CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.

    Detection was done in subjects:

    1. DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

    Measured: at Month 48

Secondary outcomes (32)

  1. Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen

    CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

    Detection was done in subjects:

    1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3

  2. Number of Subjects Reporting Solicited Local and General Symptoms

    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria.

    Data are presented across the 3 doses.

    Measured: Within 7 days after any vaccination

  3. Number of Subjects Reporting Unsolicited Adverse Events

    Unsolicited adverse event (AE) covers any AE 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.

    Measured: Within 30 days after any vaccination

  4. Number of Subjects Reporting 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.

    Measured: Throughout the entire study period (Month 0 to Month 48)

  5. Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)

    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

    Measured: Throughout the entire study (Month 0 to 48)

  6. Number of Subjects Reporting Medically Significant Conditions

    Medically significant conditions include adverse events (AEs) 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: Throughout entire study period (Month 0 to Month 48)

  7. Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus

    Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.

    Measured: Throughout the entire study period (Month 0 to Month 48)

  8. Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18

    Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

    Detection was done in subjects:

    1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3

  9. Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18

    Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

    Detection was done in subjects:

    1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

    Measured: at Month 48

  10. Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types

    Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

    Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

    HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3

  11. Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types

    Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

    Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

    HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

    Measured: at Month 48

  12. Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen

    CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

    Detection was done in subjects:

    1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

    Measured: at Month 48

  13. Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18

    Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).

    Detection was done in subjects:

    1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3

  14. Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18

    Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).

    Detection was done in subjects:

    1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
    2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

    Measured: at Month 48

  15. Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

    Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

    Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3

  16. Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

    Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

    Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

    Measured: at Month 48

  17. Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

    CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

    Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

    Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.

    Measured: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3

  18. Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

    CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

    Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

    Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.

    Measured: at Month 48

  19. Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus

    Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

    Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)

    Measured: At Months 6, 7, 12, 24, 36 & 48

  20. Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset

    Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).

    GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)].

    Measured: At Months 6, 7, 12, 24, 36 and 48

  21. HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)

    HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.

    HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL.

    Measured: Month 0, 7, 12 and 24

  22. HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)

    Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).

    Measured: Month 0, 7, 12, 24

  23. Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)

    Seropositivity was defined as subjects with a titer equal to or greater than 40.

    Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination.

    Measured: At Month 0, 7, 12, 24, 36 and 48

  24. Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)

    Titers were expressed as GMTs.

    Measured: At month 0, 7, 12, 24, 36 and 48

  25. Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection

    GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

    Measured: At Month 7

  26. Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.

    Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.

    Measured: At Month 7

  27. Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection

    GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.

    Measured: At Month 7

  28. Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection

    Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

    Measured: At Month 7

  29. Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection

    GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.

    Measured: At Month 7

  30. Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.

    Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

    Measured: At Month 7

  31. Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection

    GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.

    Measured: At Month 7

  32. Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection

    Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

    Measured: At Month 7

Timeline

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

  1. First posted22 Jul 2005 (estimated)
  2. Study start6 May 2004
  3. Primary completion3 Nov 2006
  4. Study completion26 Nov 2009

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18,729 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122681
Sponsor's protocol ID
580299/008
Status last verified
Aug 2017
First submitted
20 Jul 2005
Last updated
20 Aug 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

    PubMed 41276263

  • Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669.

    PubMed 35149535

  • Welby S, Rosillon D, Feng Y, Borys D. Progression from human papillomavirus (HPV) infection to cervical lesion or clearance in women (18-25 years): Natural history study in the control arm subjects of AS04-HPV-16/18 vaccine efficacy study in China between 2008 and 2016. Expert Rev Vaccines. 2022 Mar;21(3):407-413. doi: 10.1080/14760584.2022.2021077. Epub 2022 Jan 24.

    PubMed 34939897

  • Adhikari I, Eriksson T, Luostarinen T, Apter D, Lehtinen M. Is the risk of cervical atypia associated with the interval between menarche and the start of sexual activity? A population-based cohort study. BMJ Open. 2019 Sep 11;9(9):e030091. doi: 10.1136/bmjopen-2019-030091.

    PubMed 31511286

  • Castellsague X, Paavonen J, Jaisamrarn U, Wheeler CM, Skinner SR, Lehtinen M, Naud P, Chow SN, Del Rosario-Raymundo MR, Teixeira JC, Palmroth J, de Carvalho NS, Germar MJ, Peters K, Garland SM, Szarewski A, Poppe WA, Romanowski B, Schwarz TF, Tjalma WA, Bosch FX, Bozonnat MC, Struyf F, Dubin G, Rosillon D, Baril L; HPV PATRICIA Study Group. Risk of first cervical HPV infection and pre-cancerous lesions after onset of sexual activity: analysis of women in the control arm of the randomized, controlled PATRICIA trial. BMC Infect Dis. 2014 Oct 30;14:551. doi: 10.1186/s12879-014-0551-y.

    PubMed 25927224

  • Apter D, Wheeler CM, Paavonen J, Castellsague X, Garland SM, Skinner SR, Naud P, Salmeron J, Chow SN, Kitchener HC, Teixeira JC, Jaisamrarn U, Limson G, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Mindel A, de Sutter P, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus 16 and 18 (HPV-16/18) AS04-adjuvanted vaccine against cervical infection and precancer in young women: final event-driven analysis of the randomized, double-blind PATRICIA trial. Clin Vaccine Immunol. 2015 Apr;22(4):361-73. doi: 10.1128/CVI.00591-14. Epub 2015 Feb 4.

    PubMed 25651922

  • Struyf F, Colau B, Wheeler CM, Naud P, Garland S, Quint W, Chow SN, Salmeron J, Lehtinen M, Del Rosario-Raymundo MR, Paavonen J, Teixeira JC, Germar MJ, Peters K, Skinner SR, Limson G, Castellsague X, Poppe WA, Ramjattan B, Klein TD, Schwarz TF, Chatterjee A, Tjalma WA, Diaz-Mitoma F, Lewis DJ, Harper DM, Molijn A, van Doorn LJ, David MP, Dubin G; HPV PATRICIA Study Group. Post hoc analysis of the PATRICIA randomized trial of the efficacy of human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against incident and persistent infection with nonvaccine oncogenic HPV types using an alternative multiplex type-specific PCR assay for HPV DNA. Clin Vaccine Immunol. 2015 Feb;22(2):235-44. doi: 10.1128/CVI.00457-14. Epub 2014 Dec 24.

    PubMed 25540273

  • Castellsague X, Naud P, Chow SN, Wheeler CM, Germar MJ, Lehtinen M, Paavonen J, Jaisamrarn U, Garland SM, Salmeron J, Apter D, Kitchener H, Teixeira JC, Skinner SR, Limson G, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, de Carvalho NS, Peters K, Tjalma WA, Safaeian M, Raillard A, Descamps D, Struyf F, Dubin G, Rosillon D, Baril L. Risk of newly detected infections and cervical abnormalities in women seropositive for naturally acquired human papillomavirus type 16/18 antibodies: analysis of the control arm of PATRICIA. J Infect Dis. 2014 Aug 15;210(4):517-34. doi: 10.1093/infdis/jiu139. Epub 2014 Mar 8.

    PubMed 24610876

  • Jaisamrarn U, Castellsague X, Garland SM, Naud P, Palmroth J, Del Rosario-Raymundo MR, Wheeler CM, Salmeron J, Chow SN, Apter D, Teixeira JC, Skinner SR, Hedrick J, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, de Carvalho NS, Germar MJ, Peters K, Paavonen J, Bozonnat MC, Descamps D, Struyf F, Dubin GO, Rosillon D, Baril L; HPV PATRICIA Study Group. Natural history of progression of HPV infection to cervical lesion or clearance: analysis of the control arm of the large, randomised PATRICIA study. PLoS One. 2013 Nov 19;8(11):e79260. doi: 10.1371/journal.pone.0079260. eCollection 2013.

    PubMed 24260180

  • Valve P, Lehtinen-Jacks S, Eriksson T, Lehtinen M, Lindfors P, Saha MT, Rimpela A, Angle S. LINDA - a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. BMC Public Health. 2013 Nov 4;13:1044. doi: 10.1186/1471-2458-13-1044.

    PubMed 24188719

  • Howell-Jones R, Soldan K, Wetten S, Mesher D, Williams T, Gill ON, Hughes G. Declining genital Warts in young women in england associated with HPV 16/18 vaccination: an ecological study. J Infect Dis. 2013 Nov 1;208(9):1397-403. doi: 10.1093/infdis/jit361.

    PubMed 24092908

  • Szarewski A, Skinner SR, Garland SM, Romanowski B, Schwarz TF, Apter D, Chow SN, Paavonen J, Del Rosario-Raymundo MR, Teixeira JC, De Carvalho NS, Castro-Sanchez M, Castellsague X, Poppe WA, De Sutter P, Huh W, Chatterjee A, Tjalma WA, Ackerman RT, Martens M, Papp KA, Bajo-Arenas J, Harper DM, Torne A, David MP, Struyf F, Lehtinen M, Dubin G. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation. J Infect Dis. 2013 Nov 1;208(9):1391-6. doi: 10.1093/infdis/jit360.

    PubMed 24092907

  • Roset Bahmanyar E, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Jaisamrarn U, Limson GA, Garland SM, Szarewski A, Romanowski B, Aoki F, Schwarz TF, Poppe WA, De Carvalho NS, Harper DM, Bosch FX, Raillard A, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Prevalence and risk factors for cervical HPV infection and abnormalities in young adult women at enrolment in the multinational PATRICIA trial. Gynecol Oncol. 2012 Dec;127(3):440-50. doi: 10.1016/j.ygyno.2012.08.033. Epub 2012 Aug 30.

    PubMed 22940493

  • Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsague X, Skinner SR, Apter D, Naud P, Salmeron J, Chow SN, Kitchener H, Teixeira JC, Hedrick J, Limson G, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, De Carvalho NS, Germar MJ, Peters K, Mindel A, De Sutter P, Bosch FX, David MP, Descamps D, Struyf F, Dubin G; HPV PATRICIA Study Group. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012 Jan;13(1):89-99. doi: 10.1016/S1470-2045(11)70286-8. Epub 2011 Nov 8.

    PubMed 22075171

  • Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, Teixeira JC, Skinner SR, Jaisamrarn U, Limson G, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Harper DM, Huh W, Hardt K, Zahaf T, Descamps D, Struyf F, Dubin G, Lehtinen M; HPV PATRICIA Study Group. Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012 Jan;13(1):100-10. doi: 10.1016/S1470-2045(11)70287-X. Epub 2011 Nov 8.

    PubMed 22075170

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cervarix™ and Havrix™-based investigational formulation in people with Infections, Papillomavirus, run by GlaxoSmithKline at 138 sites in 14 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 8 inclusion and 17 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Finland, Germany, Canada, Australia and 9 more countries. 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 20 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (time frame: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3). 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 NCT00122681, which also lists 19 linked publications.

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 20 Aug 2018.

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