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

• ClinicalTrials.gov Identifier: NCT00122681
• Recruitment Status: Completed
• First Posted: July 22, 2005
• Results First Posted: January 20, 2010
• Last Update Posted: August 20, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief 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). 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.

Condition or disease	Intervention/treatment	Phase
Infections, Papillomavirus	Biological: Cervarix™; Biological: Havrix™-based investigational formulation	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18729 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: May 6, 2004
• Actual Primary Completion Date: November 3, 2006
• Actual Study Completion Date: November 26, 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cervarix Group; Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.	Biological: Cervarix™; Intramuscular injection, 3 doses; Other Name: GSK Biologicals HPV 16/18 VLP/AS04 vaccine
Active Comparator: Havrix Group; Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Biological: Havrix™-based investigational formulation; Intramuscular injection, 3 doses

Outcome Measures

Primary Outcome Measures :

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) [ 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 ]

   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.
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) [ Time Frame: at Month 48 ]

   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.

Secondary Outcome Measures :

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 [ 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 ]

   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
2. Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days after any vaccination ]

   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.

3. Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within 30 days after any vaccination ]
   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.
4. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the entire study period (Month 0 to Month 48) ]
   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.
5. Number of Subjects Reporting New Onset of Chronic Disease (NOCDs) [ Time Frame: Throughout the entire study (Month 0 to 48) ]
   NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
6. Number of Subjects Reporting Medically Significant Conditions [ Time Frame: Throughout entire study period (Month 0 to Month 48) ]
   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.
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 [ Time Frame: Throughout the entire study period (Month 0 to Month 48) ]
   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.
8. Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 [ 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 ]

   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
9. Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 [ Time Frame: at Month 48 ]

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

    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

11. Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types [ Time Frame: at Month 48 ]

    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

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 [ Time Frame: at Month 48 ]

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

    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
14. Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 [ Time Frame: at Month 48 ]

    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
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 [ 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 ]

    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.

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 [ Time Frame: at Month 48 ]

    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.

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 [ 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 ]

    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.

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 [ Time Frame: at Month 48 ]

    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.

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 [ Time Frame: At Months 6, 7, 12, 24, 36 & 48 ]

    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+)

20. Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset [ Time Frame: At Months 6, 7, 12, 24, 36 and 48 ]

    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+)].

21. HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) [ Time Frame: Month 0, 7, 12 and 24 ]

    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.

22. HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) [ Time Frame: Month 0, 7, 12, 24 ]
    Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).
23. Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) [ Time Frame: At Month 0, 7, 12, 24, 36 and 48 ]

    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.

24. Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) [ Time Frame: At month 0, 7, 12, 24, 36 and 48 ]
    Titers were expressed as GMTs.
25. Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection [ Time Frame: At Month 7 ]
    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.
26. Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection. [ Time Frame: At Month 7 ]
    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.
27. Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection [ Time Frame: At Month 7 ]
    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.
28. Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection [ Time Frame: At Month 7 ]
    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.
29. Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection [ Time Frame: At Month 7 ]
    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.
30. Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection. [ Time Frame: At Month 7 ]
    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.
31. Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection [ Time Frame: At Month 7 ]
    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.
32. Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection [ Time Frame: At Month 7 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Contacts and Locations

Locations

United States, Alabama

GSK Investigational Site

Birmingham, Alabama, United States, 35233

United States, California

GSK Investigational Site

Fountain Valley, California, United States, 92708

GSK Investigational Site

San Diego, California, United States, 92108

GSK Investigational Site

San Francisco, California, United States, 94115

United States, Colorado

GSK Investigational Site

Boulder, Colorado, United States, 80303

GSK Investigational Site

Boulder, Colorado, United States, 80304

GSK Investigational Site

Denver, Colorado, United States, 80218

GSK Investigational Site

Louisville, Colorado, United States, 80027

United States, Florida

GSK Investigational Site

Clearwater, Florida, United States, 33759

GSK Investigational Site

Coral Gables, Florida, United States, 33134

GSK Investigational Site

Miami, Florida, United States, 33136

GSK Investigational Site

West Palm Beach, Florida, United States, 33409

United States, Georgia

GSK Investigational Site

Augusta, Georgia, United States, 30912

United States, Hawaii

GSK Investigational Site

Honolulu, Hawaii, United States, 96826

United States, Iowa

GSK Investigational Site

Iowa City, Iowa, United States, 52242

United States, Kansas

GSK Investigational Site

Arkansas City, Kansas, United States, 67005

GSK Investigational Site

Wichita, Kansas, United States, 67205

GSK Investigational Site

Wichita, Kansas, United States, 67207

United States, Kentucky

GSK Investigational Site

Bardstown, Kentucky, United States, 40004

GSK Investigational Site

Louisville, Kentucky, United States, 40202

United States, Minnesota

GSK Investigational Site

Minneapolis, Minnesota, United States, 55455

United States, Nebraska

GSK Investigational Site

Omaha, Nebraska, United States, 68131

United States, New Hampshire

GSK Investigational Site

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

GSK Investigational Site

Morristown, New Jersey, United States, 07960

United States, New Mexico

GSK Investigational Site

Albuquerque, New Mexico, United States, 87131

United States, New York

GSK Investigational Site

New York, New York, United States, 10029

GSK Investigational Site

Poughkeepsie, New York, United States, 12601

United States, North Carolina

GSK Investigational Site

Chapel Hill, North Carolina, United States, 27514

GSK Investigational Site

New Bern, North Carolina, United States, 28562

United States, Ohio

GSK Investigational Site

Cleveland, Ohio, United States, 44109

United States, Oklahoma

GSK Investigational Site

Tulsa, Oklahoma, United States, 74105

United States, Oregon

GSK Investigational Site

Portland, Oregon, United States, 97210

United States, Pennsylvania

GSK Investigational Site

Carnegie, Pennsylvania, United States, 15106

GSK Investigational Site

Erie, Pennsylvania, United States, 16502

GSK Investigational Site

Erie, Pennsylvania, United States, 16505

GSK Investigational Site

Erie, Pennsylvania, United States, 16507

GSK Investigational Site

Erie, Pennsylvania, United States, 16508

GSK Investigational Site

Philadelphia, Pennsylvania, United States, 19107

GSK Investigational Site

Philadelphia, Pennsylvania, United States, 19114

GSK Investigational Site

Pittsburgh, Pennsylvania, United States, 15236

United States, Texas

GSK Investigational Site

Austin, Texas, United States, 78705

GSK Investigational Site

Houston, Texas, United States, 77004

GSK Investigational Site

Houston, Texas, United States, 77030

GSK Investigational Site

Webster, Texas, United States, 77598

United States, Utah

GSK Investigational Site

Salt Lake City, Utah, United States, 84120

United States, Virginia

GSK Investigational Site

Charlottesville, Virginia, United States, 22903

United States, Washington

GSK Investigational Site

Spokane, Washington, United States, 99202

GSK Investigational Site

Spokane, Washington, United States, 99218

GSK Investigational Site

Vancouver, Washington, United States, 98664

GSK Investigational Site

Wenatchee, Washington, United States, 98801

Australia, New South Wales

GSK Investigational Site

Sydney, New South Wales, Australia, 4001

Australia, South Australia

GSK Investigational Site

Adelaide, South Australia, Australia, 5000

Australia, Tasmania

GSK Investigational Site

Hobart, Tasmania, Australia

Australia, Victoria

GSK Investigational Site

Carlton, Melbourne, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

Australia, Western Australia

GSK Investigational Site

Perth, Western Australia, Australia

Belgium

GSK Investigational Site

Brussels, Belgium, 1090

GSK Investigational Site

Edegem, Belgium, 2650

GSK Investigational Site

Leuven, Belgium, 3000

Brazil

GSK Investigational Site

Curitiba, Paraná, Brazil, 80069-900

GSK Investigational Site

Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903

GSK Investigational Site

Campinas, São Paulo, Brazil

Canada, Alberta

GSK Investigational Site

Edmonton, Alberta, Canada, T6G 2C8

Canada, British Columbia

GSK Investigational Site

Langley, British Columbia, Canada, V3A 4H9

Canada, Manitoba

GSK Investigational Site

Winnipeg, Manitoba, Canada, R3E 0J9

Canada, Newfoundland and Labrador

GSK Investigational Site

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

Canada, Nova Scotia

GSK Investigational Site

Truro, Nova Scotia, Canada, B2N 1L2

Canada, Ontario

GSK Investigational Site

Oshawa, Ontario, Canada, L1H 1C2

GSK Investigational Site

Ottawa, Ontario, Canada, K1S 1C2

GSK Investigational Site

Toronto, Ontario, Canada, M4N 3M5

GSK Investigational Site

Waterloo, Ontario, Canada, N2J 1C4

Canada, Quebec

GSK Investigational Site

Beauport, Quebec, Canada, G1E 7G9

GSK Investigational Site

Montreal, Quebec, Canada, H3T 1E2

Finland

GSK Investigational Site

Espoo, Finland, 02100

GSK Investigational Site

Helsinki, Finland, 00100

GSK Investigational Site

Helsinki, Finland, 00610

GSK Investigational Site

Jarvenpaa, Finland, 04400

GSK Investigational Site

Jyvaskyla, Finland, 40100

GSK Investigational Site

Kerava, Finland, 04250

GSK Investigational Site

Kotka, Finland, 48100

GSK Investigational Site

Kouvola, Finland, 45100

GSK Investigational Site

Kuopio, Finland, 70100

GSK Investigational Site

Lahti, Finland, 15110

GSK Investigational Site

Lappeenranta, Finland, 53100

GSK Investigational Site

Mikkeli, Finland, 50100

GSK Investigational Site

Oulu, Finland, 90220

GSK Investigational Site

Pori, Finland, 28100

GSK Investigational Site

Rauma, Finland, 26100

GSK Investigational Site

Seinajoki, Finland, 60100

GSK Investigational Site

Tampere, Finland, 33100

GSK Investigational Site

Turku, Finland, 20520

GSK Investigational Site

Vaasa, Finland, 65100

Germany

GSK Investigational Site

Karlsruhe, Baden-Wuerttemberg, Germany, 76199

GSK Investigational Site

Ravensburg, Baden-Wuerttemberg, Germany, 88212

GSK Investigational Site

Rheinstetten, Baden-Wuerttemberg, Germany, 76287

GSK Investigational Site

Muenchen, Bayern, Germany, 80331

GSK Investigational Site

Muenchen, Bayern, Germany, 80637

GSK Investigational Site

Wuerzburg, Bayern, Germany, 97070

GSK Investigational Site

Dietzenbach, Hessen, Germany, 63128

GSK Investigational Site

Frankfurt, Hessen, Germany, 60439

GSK Investigational Site

Frankfurt, Hessen, Germany, 65936

GSK Investigational Site

Hannover, Niedersachsen, Germany, 30657

GSK Investigational Site

Mainz, Rheinland-Pfalz, Germany, 55116

GSK Investigational Site

Leipzig, Sachsen, Germany, 04109

GSK Investigational Site

Nordhausen, Thueringen, Germany, 99734

GSK Investigational Site

Berlin, Germany, 10119

GSK Investigational Site

Berlin, Germany, 13086

GSK Investigational Site

Hamburg, Germany, 20246

GSK Investigational Site

Hamburg, Germany, 22143

GSK Investigational Site

Hamburg, Germany, 22149

GSK Investigational Site

Hamburg, Germany, 22159

Italy

GSK Investigational Site

Modena, Emilia-Romagna, Italy, 41150

GSK Investigational Site

Milano, Lombardia, Italy, 20122

Mexico

GSK Investigational Site

Cuenavaca, Morelos, Mexico, 62430

Philippines

GSK Investigational Site

Cavite, Philippines

GSK Investigational Site

Laguna, Philippines

GSK Investigational Site

Las Pinas City, Philippines

GSK Investigational Site

Los Banos, Laguna, Philippines, 4027

GSK Investigational Site

Makati City, Philippines, 1231

GSK Investigational Site

Manila, Philippines, 1000

Spain

GSK Investigational Site

Barcelona, Spain, 08035

GSK Investigational Site

Barcelona, Spain, 08036

GSK Investigational Site

L'Hospitalet de Llobregat, Spain, 08907

GSK Investigational Site

Madrid, Spain, 28009

GSK Investigational Site

Marid, Spain, 28040

GSK Investigational Site

Móstoles, Spain, 28935

Taiwan

GSK Investigational Site

Taipei, Taiwan, 100

GSK Investigational Site

Taipei, Taiwan, 112

GSK Investigational Site

Taipei, Taiwan, 114

Thailand

GSK Investigational Site

Bangkok, Thailand, 10330

GSK Investigational Site

Bangkok, Thailand, 10400

GSK Investigational Site

Bangkok, Thailand, 10700

United Kingdom

GSK Investigational Site

Aberdeen, United Kingdom, AB25 2ZN

GSK Investigational Site

London, United Kingdom, SW17 0QT

GSK Investigational Site

London, United Kingdom, W1P 1LB

GSK Investigational Site

Manchester, United Kingdom, M13 9WL

GSK Investigational Site

Manchester, United Kingdom, M15 6SX

GSK Investigational Site

Waterloo, Liverpool, United Kingdom, L22 0LG

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Dataset Specification 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 580299/008
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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.

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. Erratum In: PLoS One. 2013;8(12). doi:10.1371/annotation/cea59317-929c-464a-b3f7-e095248f229a.

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.

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.

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.

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.

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. Erratum In: Lancet Oncol. 2012 Jan;13(1):e1.

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. Erratum In: Lancet Oncol. 2012 Jan;13(1):e1.

Szarewski A, Poppe WA, Skinner SR, Wheeler CM, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Hedrick J, Jaisamrarn U, Limson G, Garland S, Romanowski B, Aoki FY, Schwarz TF, Bosch FX, Harper DM, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18. Int J Cancer. 2012 Jul 1;131(1):106-16. doi: 10.1002/ijc.26362. Epub 2011 Oct 23.

Wacholder S, Chen BE, Wilcox A, Macones G, Gonzalez P, Befano B, Hildesheim A, Rodriguez AC, Solomon D, Herrero R, Schiffman M; CVT group. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ. 2010 Mar 2;340:c712. doi: 10.1136/bmj.c712.

Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6. Erratum In: Lancet. 2010 Sep 25;376(9746):1054.

Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter DL, Kitchener HC, Castellsague X, de Carvalho NS, Skinner SR, Harper DM, Hedrick JA, Jaisamrarn U, Limson GA, Dionne M, Quint W, Spiessens B, Peeters P, Struyf F, Wieting SL, Lehtinen MO, Dubin G; HPV PATRICIA study group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet. 2007 Jun 30;369(9580):2161-2170. doi: 10.1016/S0140-6736(07)60946-5. Erratum In: Lancet. 2007 Oct 20;370(9596):1414.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00122681
• Other Study ID Numbers: 580299/008
• First Posted: July 22, 2005
• Results First Posted: January 20, 2010
• Last Update Posted: August 20, 2018
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

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

Additional relevant MeSH terms:

Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs