Long-Term PF-06651600 for the Treatment of Alopecia Areata

Alopecia Areata Clinical Trial

— ALLEGRO-LT  

Official title:

A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04006457
• Other study ID #: B7981032
• Secondary ID: 2019-001084-71AL
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 18, 2019
• Est. completion date: February 4, 2026

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1051
• Est. completion date: February 4, 2026
• Est. primary completion date: July 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

• Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.

• De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis

• De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis

• No evidence of terminal scalp hair regrowth within 6 months (de novo only)

• Current episode of terminal scalp hair loss <=10 years (de novo only)

Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

• Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive

• History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ

• History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster

• Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Exclusion criteria for all participants:

• Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• PF-06651600
50 mg oral tablets/capsules

Biological:
• Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
• Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study

Locations

Country	Name	City	State
Argentina	CINME Centro de Investigaciones Metabolicas	Caba	Buenos Aires
Argentina	Psoriahue Medicina Interdisciplinaria	Caba
Australia	The Skin Centre	Benowa	Queensland
Australia	Skin Health Institute	Carlton	Victoria
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Premier Specialists Pty Ltd	Kogarah	New South Wales
Australia	St George Dermatology & Skin Cancer Centre	Kogarah	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal Melbourne Hospital, Melbourne Health	Parkville	Victoria
Australia	Royal Melbourne Hospital, Melbourne Health	Parkville	Victoria
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Canada	Eastern Canada Cutaneous Research Associates Ltd.	Halifax	Nova Scotia
Canada	Guenther Research Inc	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	The Centre for Clinical Trials	Oakville	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario
Canada	Medicor Research Inc	Sudbury	Ontario
Canada	Medicor Research Inc	Sudbury	Ontario
Canada	Sudbury Skin Clinique	Sudbury	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Chile	Centro Internacional de Estudios Clinicos - CIEC	Santiago	Recoleta
Chile	Centro Medico Skin Med	Santiago	LAS Condes
Chile	Clinica Dermacross S.A.	Santiago	Vitacura
Chile	Medical Skin Center	Vina del Mar	Valparaiso
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The University of Hong Kong - Shenzhen Hospital	Shenzhen	Guangdong
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S	Bogota D.C.
Colombia	Fundacion Centro de Investigacion Clinica CIC	Medellin	Antioquia
Colombia	Fundacion Hospitalaria San Vicente de Paul	Medellin	Antioquia
Czechia	DERMAMEDICA s.r.o.	Nachod
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Sanatorium profesora Arenbergera	Praha 1
Czechia	Clintrial s.r.o.	Praha 10
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Lower Saxony
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Emovis GmbH	Berlin
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	University Hospital Frankfurt	Frankfurt am Main
Germany	University Hospital Schleswig-Holstein	Luebeck
Germany	University Hospital Muenster	Muenster
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Juntendo Tokyo Koto Geriatric Medical Center	Koto-ku	Tokyo
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Tokyo Medical University Hospital	Tokyo
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Hospital D Maria	Veracruz
Mexico	Sociedad de Metabolismo y Corazon S.C.	Veracruz
Poland	McBk S.C.	Grodzisk Mazowiecki
Poland	Centermed Krakow Sp.z o.o.	Krakow
Poland	Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak	Lodz
Poland	Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Twoja Przychodnia SCM	Szczecin	Zachodniopomorskie
Poland	ETG Warszawa	Warszawa
Poland	Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej	Warszawa
Poland	RCMed Oddzial Warszawa	Warszawa
Poland	Royalderm Agnieszka Nawrocka	Warszawa
Poland	Centrum Medyczne OPOROW	Wroclaw
Poland	Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spólka Partnerska	Wroclaw
Poland	EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu	Wroclaw
Russian Federation	State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"	Chelyabinsk
Russian Federation	University Clinic of Kirov SMU	Kirov
Russian Federation	Clinical Medical Center of Moscow State University of Medicine and Dentistry	Moscow
Russian Federation	Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"	Moscow
Russian Federation	State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"	Rostov-on-Don
Russian Federation	Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)	Saint Petersburg
Russian Federation	Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -	Saint Petersburg
Russian Federation	Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"	Saint Petersburg,
Russian Federation	State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital	Yaroslavl
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Paz: Servicio de Farmacia	Madrid
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City
Taiwan	Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare	New Taipei City
Taiwan	Chung-Shan Medical University Hospital	Taichung	R.o.c.
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital	Taoyuan City
United Kingdom	University Hospitals Sussex NHS Foundation Trust (UHSussex)	Brighton
United Kingdom	NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital	Glasgow
United Kingdom	Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital	London
United Kingdom	Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital	London
United Kingdom	Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital	London
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Colorado Hospital Clinical and Translational Research Center	Aurora	Colorado
United States	University of Colorado Hospital Outpatient Pavilion	Aurora	Colorado
United States	The University of Texas Health Science Center at Houston	Bellaire	Texas
United States	Mosaic Dermatology	Beverly Hills	California
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	The University of Alabama at Birmingham Hosptial Outreach Lab	Birmingham	Alabama
United States	The University of Alabama at Birmingham, Department of Dermatology	Birmingham	Alabama
United States	Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)	Boston	Massachusetts
United States	Siperstein Dermatology Group	Boynton Beach	Florida
United States	UNC CTRC	Chapel Hill	North Carolina
United States	UNC Dermatology and Skin Cancer Center	Chapel Hill	North Carolina
United States	UNC Dermatology Clinical Trials Unit	Chapel Hill	North Carolina
United States	UNC Hospitals, Investigational Drug Service	Chapel Hill	North Carolina
United States	Medstar Georgetown University Hospital - Department of Dermatology	Chevy Chase	Maryland
United States	Northwestern Medical Group	Chicago	Illinois
United States	Northwestern Medicine	Chicago	Illinois
United States	Northwestern Medicine Diagnostic Testing Center	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern Memorial Hospital Investigational Drug Service Pharmacy	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Univ of California, Irvine, Dermatology Clinical Research Center	Irvine	California
United States	Velocity Clinical Research - Boise	Meridian	Idaho
United States	University of Minnesota Clinical Research Unit (CRU)	Minneapolis	Minnesota
United States	University of Minnesota Lillehei Clinical Research Unit (LCRU)	Minneapolis	Minnesota
United States	University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke	Minneapolis	Minnesota
United States	Dermatology Specialists Inc.	Murrieta	California
United States	Investigational Drug Services	New Haven	Connecticut
United States	Yale School of Medicine	New Haven	Connecticut
United States	Yale School of Medicine, Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Yale School of Medicine, Yale Center for Clinical Investigations	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU School of Medicine, The Ronald O. Perelman Department of Dermatology	New York	New York
United States	Pura Dermatology (in c/o TrialSpark, Inc)	New York	New York
United States	Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)	Oakbrook Terrace	Illinois
United States	Skin Specialists PC	Omaha	Nebraska
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Oregon Medical Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Kaiser Permanente Clinical Trials Unit	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	NorthShore University HealthSystem Dermatology Clinical Trials Unit	Skokie	Illinois
United States	Northshore University HealthSystem/Dermatology	Skokie	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	ForCare Clinical Research	Tampa	Florida
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Schweiger Dermatology, P.C.	Verona	New Jersey
United States	Tamjidi Skin Institute (in c/o TrialSpark, Inc)	Vienna	Virginia
United States	Medstar Georgetown University Hospital - Department of Otolaryngology	Washington	District of Columbia
United States	Medstar Georgetown University Hospital - Department of Pediatrics	Washington	District of Columbia
United States	Medstar Georgetown University Hospital-Dept of Otolaryngology	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Medstar Washington Hospital Center-Claude Nogay Research Pharmacy	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  China,  Colombia,  Czechia,  Germany,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting treatment-emergent adverse events		Baseline through Month 36
Primary	Number of subjects reporting serious adverse events		Baseline through Month 36
Primary	Number of subjects reporting adverse events leading to discontinuation		Baseline through Month 36
Primary	Number of subjects with clinically significant abnormalities in vital signs		Baseline through Month 36
Primary	Number of subjects with clinically significant abnormalities in clinical laboratory values		Baseline through Month 36
Primary	Vaccine sub-study: Percentage of subjects with a tetanus booster response	Tetanus booster response is defined as 1) =4 fold rise in anti-tetanus toxoid IgG antibody concentration at Day 30 if the pre-vaccination concentration was =2.7 IU/mL; 2) =2 fold rise in anti tetanus toxoid IgG antibody if the pre-vaccination concentration was >2.7 IU/mL	Vaccine sub-study Month 1
Secondary	Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary	Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary	Change from baseline in SALT score	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary	Percentage of subjects with a 75% improvement in SALT score from baseline	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary	Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score	EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).	Months 1, 3, 6, 12, 18, 24, and 36
Secondary	Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score	ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).	Months 1, 3, 6, 12, 18, 24, and 36
Secondary	Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved"	PGI-C is a self administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has: …", with 7 responses ranging from "greatly improved" to "greatly worsened."	Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary	Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains	The AAPPO scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.	Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary	Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS)	HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary	Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)	HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary	Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of depression who achieved a "normal" subscale score indicative of an absence of depression	HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary	Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of anxiety who achieved a "normal" subscale score indicative of an absence of anxiety	HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary	Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response	Meningococcal serogroup C response is defined as achieving =1:8 human serum bactericidal activity (hSBA) (in participants with undetectable pre-vaccination assay titers)	Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level =1.0 IU/mL		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level =0.1 IU/mL		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Percentage of subjects with =4x increase in anti-tetanus antibody level from baseline		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Percentage of subjects with =1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C		Vaccine sub-study Day 1 and Month 1
Secondary	Number of subjects reporting treatment-emergent adverse events		Month 37 through Month 60
Secondary	Number of subjects reporting serious adverse events		Month 37 through Month 60
Secondary	Number of subjects reporting adverse events leading to discontinuation		Month 37 through Month 60
Secondary	Number of subjects with clinically significant abnormalities in vital signs		Month 37 through Month 60
Secondary	Number of subjects with clinically significant abnormalities in clinical laboratory values		Month 37 through Month 60
Secondary	Vaccine sub-study: Number of subjects reporting serious adverse events		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Number of subjects reporting adverse events		Vaccine sub-study Month 1
Secondary	Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation		Vaccine sub-study Month 1

External Links

•   To obtain contact information for a study center near you, click here.