Clearwater, Florida 33759

  • Infections, Papillomavirus

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

580299/008


NCT ID:

NCT00122681


Secondary ID:


Study Acronym:


Brief Title:

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


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 Infe


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

15 Years


Maximum Age:

25 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

18729


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:May 6, 2004
Completion Date:November 26, 2009
Completion Type:Actual
Primary Completion Date:November 3, 2006
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:July 2, 2018
First Received Date:July 20, 2005
First Results Date:November 30, 2009

Study Outcomes

Outcome Type: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
Safety Issues:False
Description:CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding
Outcome Type: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:at Month 48
Safety Issues:False
Description:CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in subjects: DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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: DNA- and sero-: subjects HPV DNA
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Solicited Local and General Symptoms
Time Frame:Within 7 days after any vaccination
Safety Issues:False
Description: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 urtica
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Unsolicited Adverse Events
Time Frame:Within 30 days after any vaccination
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame:Throughout the entire study period (Month 0 to Month 48)
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection
Time Frame:At Month 7
Safety Issues:False
Description: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 seronegati
Outcome Type:Secondary Outcome
Measure:Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection
Time Frame:At Month 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.
Time Frame:At Month 7
Safety Issues:False
Description: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 seronegativ
Outcome Type:Secondary Outcome
Measure:Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection
Time Frame:At Month 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection
Time Frame:At Month 7
Safety Issues:False
Description: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 seronegati
Outcome Type:Secondary Outcome
Measure:Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection
Time Frame:At Month 7
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.
Time Frame:At Month 7
Safety Issues:False
Description: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 seronegativ
Outcome Type:Secondary Outcome
Measure:Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection
Time Frame:At Month 7
Safety Issues:False
Description: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 Mon
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:Titers were expressed as GMTs.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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 seropo
Outcome Type:Secondary Outcome
Measure:HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)
Time Frame:Month 0, 7, 12, 24
Safety Issues:False
Description:Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).
Outcome Type:Secondary Outcome
Measure:HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)
Time Frame:Month 0, 7, 12 and 24
Safety Issues:False
Description: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 greate
Outcome Type:Secondary Outcome
Measure:Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset
Time Frame:At Months 6, 7, 12, 24, 36 and 48
Safety Issues:False
Description: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 se
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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,
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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,
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18
Time Frame:at Month 48
Safety Issues:False
Description: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: DNA- and sero-: su
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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: DNA- and sero-: su
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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: DNA- and sero-: subjects HPV DNA
Outcome Type:Secondary Outcome
Measure:Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types
Time Frame:at Month 48
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18
Time Frame:at Month 48
Safety Issues:False
Description: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 subj
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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 subj
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Medically Significant Conditions
Time Frame:Throughout entire study period (Month 0 to Month 48)
Safety Issues:False
Description: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 rel
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)
Time Frame:Throughout the entire study (Month 0 to 48)
Safety Issues:False
Description:NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Study Interventions

Intervention Type:Biological
Name:Cervarix™
Description:Intramuscular injection, 3 doses
Arm Name:Cervarix Group
Other Name:GSK Biologicals HPV 16/18 VLP/AS04 vaccine
Intervention Type:Biological
Name:Havrix™-based investigational formulation
Description:Intramuscular injection, 3 doses
Arm Name:Havrix Group

Study Arms

Study Arm Type:Experimental
Arm Name:Cervarix Group
Description:Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Study Arm Type:Active Comparator
Arm Name:Havrix Group
Description:Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Tjalma W et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against abnormal cytology and low-grade histopathological lesions in an oncogenic HPV-naïve population. Abstract presented at the 16th International Meeting of European Society of Gynaecological Oncology. Belgrade, Serbia, 11-14 October 2009.
Reference Type:Reference
Citation:Poppe W et al. Vaccine efficacy in women with evidence of prior HPV-16/18 infection and incomplete protection by natural immunity: analysis from a Phase III, double blind, randomised trial of the AS04-adjuvanted HPV-16/18 vaccine. Abstract presented at the 16th International Meeting of European Society of Gynaecological Oncology. Belgrade, Serbia, 11-14 October 2009.
Reference Type:Reference
Citation:Chow SN et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against abnormal cytology and reduction in colposcopy referrals and cervical excisions in an HPV-negative population. Abstract presented at the 16th International Meeting of European Society of Gynaecological Oncology. Belgrade, Serbia, 11-14 October 2009.
Reference Type:Reference
Citation:Wheeler C et al. Cross-protective efficacy of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine against cervical intraepithelial neoplasia 2+ in a Phase III, double-blind, randomised trial (PATRICIA). Abstract presented at the 16th International Meeting of European Society of Gynaecological Oncology. Belgrade, Serbia, 11-14 October 2009.
Reference Type:Reference
Citation:Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8.
PMID:18845199
Reference Type:Reference
Citation: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):2161-70.
PMID:17602732
Reference Type:Reference
Citation:Szarewski A et al. Cross-protective efficacy of CervarixTM against oncogenic types beyond HPV-16/18 : analysis of the According-to-Protocol (ATP) cohort in a double blind, randomized controlled Phase III efficacy trial. Abstract presented at FIGO 2009 - 19th World Congress of Gynecology & Obstetrics. Cape Town, South Africa, 4-9 October, 2009.
Reference Type:Reference
Citation:Wacholder S et al. (2010) Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ. 340:c712
Reference Type:Reference
Citation:Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.
Reference Type:Reference
Citation:Paavonen J, Naud P, Salmerón 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; Greenacre M. 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. Epub 2009 Jul 6.
PMID:19586656
Reference Type:Reference
Citation:Kitchener H et al. Cross-protective efficacy of the AS04-adjuvanted HPV-16/18 vaccine in oncogenic HPV infection-naïve women: results from a double-blind, randomised, Phase III trial (PATRICIA). Abstract presented at the 16th International Meeting of European Society of Gynaecological Oncology. Belgrade, Serbia, 11-14 October 2009.
Reference Type:Reference
Citation:Skinner R. S et al. Cross-protective efficacy of Cervarix™ against oncogenic HPV types beyond HPV-16/18. Abstract presented at International Papillomavirus Conference and Clinical Workshop (IPvC). Malmo, Sweden, 8-14 May 2009.
Reference Type:Reference
Citation:Naud P et al. Cross-protective efficacy of the ASO4-adjuvanted HPV-16/18 vaccine against oncogenic HPV-31, -33 and - 45. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Reference Type:Reference
Citation:Romanowski B et al. Clinical benefit of the AS04-adjuvanted human papillomavirus 16/18 vaccine against CIN2+ related to the 5 most common oncogenic HPV types: PATRICIA trial. Abstract presented at IDSA. Philadelphia, USA, 29 October-1 November, 2009.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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