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

Phase 3

Active, not recruiting

Conditions: Alopecia Areata

Interventions: Drug: PF-06651600
Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Registration Number: NCT04006457

Lead Sponsor: Pfizer

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 1052

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1	PF-06651600	Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment sequence 1	Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine	Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment sequence 2	PF-06651600	Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment sequence 1	Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine	Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment sequence 2	Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine	Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment sequence 2	Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine	Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.

Primary Outcome Measures

Name	Time	Method
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)	Vital signs including blood pressure included systolic blood pressure (SBP) \[Millimeters of mercury, mmHg\]) and diastolic blood pressure (DBP) and pulse rate \[beats per minute (bpm)\] were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Criteria for vital sign abnormalities included: SBP\<90mmHg, DBP\<50 mmHg and pulse rate\<40mmHg.
Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)	Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (\<0.8\LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration \<0.8\LLN or \>1.5\LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (\>1.2\ULN), Prothrombin Time(\>1.1\ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5\ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (\>3.0\ULN); Albumin, Urate (\<0.8\LLN and \>1.2\ULN; Urea Nitrogen,Creatinine Cholesterol \>1.3\ULN; Cholesterol \<0.8\LLN or \>1.2\LLN, Triglycerides,Potassium,Calcium \< 0.9x LLN \& \> 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite \>=1; Leukocyte Erythrocytes, Leukocytes \>=20; Epithelial Cells\>=6, Hyaline Cast\>1; Bacteria\>20. Number of participants with any laboratory abnormality meeting specified criteria is included.
Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response	Month 1	Booster response to tetanus toxoid was defined as: \>=4-fold rise in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration at Month 1 if the pre-vaccination concentration was \<=2.7 International Units per milliliter (IU/mL); OR \>=2-fold rise in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination concentration was \>2.7 IU/mL. Two-sided 95% confidence interval (CI) was based on Clopper-Pearson exact method.

Secondary Outcome Measures

Name	Time	Method
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of Study	From start of study intervention (Day 1) until end of study	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until End of Study	From start of study intervention (Day 1) until end of study	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Until End of Study	From start of study intervention (Day 1) until end of study	Vital signs including blood pressure (systolic and diastolic blood pressure \[Millimeters of mercury, mmHg\]) and pulse rate (beats per minute \[bpm\]) were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Clinically significant abnormalities will be determined by investigator.
Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study	From start of study intervention (Day 1) until end of study	Following laboratory parameters were assessed: Hemoglobin, Hematocrit, Erythrocytes Erythrocyte (ery.) corpuscular volume, Ery. Mean Corpuscular hemoglobin concentration, Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils, Monocytes, Prothrombin Time, Bilirubin, Direct Bilirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase; Albumin, Urate; Urea Nitrogen, Creatinine, Cholesterol, Triglycerides, Potassium, Calcium, Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite, Leukocyte Erythrocytes, Leukocytes; Epithelial Cells, Hyaline Cast, Bacteria. Clinically significant abnormalities will be determined by investigator.
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \<= 10 were reported. 95% CI was calculated based on normal approximation.
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \<=20 were reported. 95% CI was calculated based on normal approximation.
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing division of scalp hair into four quadrants (back, top of scalp, right side and left side), with each of four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score is sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into 4 quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss). SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), lower score= less hair loss. Baseline (Roll-over participants: Day 1 from Study B7931005 or B7981015; De novo participants: Day 1 from Study B7981032).
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). An Overall SALT 75 response was a 75% or greater reduction from baseline in SALT score.
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score= SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), where lower score=less hair loss. SALT 75 response= 75% or greater reduction from baseline in AA SALT score.
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline	At Months 1, 3, 6, 12, 18, 24 and 36	EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow. Higher scores represent lesser loss of eyebrow hair. 95% CI was based on normal approximation.
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline	At Months 1, 3, 6, 12, 18, 24 and 36	ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash. Higher scores represent lesser loss of eyelash hair.
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36	At Months 1, 3, 6, 9, 12, 18, 24 and 36	PGI-C is a self-administered single item questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. Participants were required to select their response on a 7-point scale ranging from 1 (greatly worsened), 2=moderately worsened, 3=slightly worsened, 4=not changed, 5= slightly improved, 6=moderately improved, 7 (greatly improved). 95% CI was based on normal approximation.
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36	AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 5-8 assessed emotional symptoms with responses scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations with responses scored from 0='not at all' to 4='completely'. AAPPO emotional symptoms sub score was calculated as mean of items 5-8 and ranged from 0 (never) to 4 (always), where higher scores indicated more emotional symptoms. AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36	AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss from the scalp, eyebrows, eyelashes and body using a 5 point scale that ranged from 0 ='no hair loss' and 4='complete hair loss'. In this outcome measure, percentage of participants with AAPPO domain scores of 0 = no hair loss or 1 = a little hair loss, among participants with score \>=2 at baseline are reported.
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36	At Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. Improvement on HADS depression score was considered as achieving a "normal" depression subscale score indicative of an absence of depression. Among adults, a HADS-D score of 0-7 was considered "normal"; for adolescents, a HADS-D score of 0-6 was considered "normal". 95% CI was calculated based on normal approximation.
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36	At Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. Improvement on HADS anxiety score was considered as achieving a "normal" anxiety subscale score indicative of an absence of anxiety. Among adults, a HADS-A score of 0-7 was considered "normal"; for adolescents, a HADS-A score of 0-8 was considered "normal". 95% CI was calculated based on normal approximation.
Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=1.0 International Units Per Milliliter (IU/mL) at Month 1-Tdap Vaccination	Month 1	Percentage of participants with anti-tetanus antibody level \>=1.0 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.
Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=0.1 IU/mL at Month 1-Tdap Vaccination	Month 1	Percentage of participants with anti-tetanus antibody level \>=0.1 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.
Vaccine Sub-study: Percentage of Participants With >=4 Times Increase in Anti-tetanus Antibody Level From Baseline at Month 1-Tdap Vaccination	Month 1	Percentage of participants with \>=4 times increase in anti-tetanus antibody level from baseline were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.
Vaccine Sub-study: Geometric Mean Fold Change in Anti-tetanus Levels Above Baseline Values at Month 1-Tdap Vaccination	From Baseline (pre-vaccination on Day 1) to Month 1	Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Fold change was defined as the ratio of the post-baseline result to the baseline result. The assay results below the LLOQ were set to 0.5 \* LLOQ except when pre-vaccination assay results is \< LLOQ while postvaccination result is \>= LLOQ, in which case the pre-vaccination value will be set to LLOQ.
Vaccine Sub-study: Geometric Mean Concentrations (GMCs) of Anti-tetanus Antibody Levels at Month 1-Tdap Vaccination	Month 1	Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\* LLOQ.
Vaccine Sub-study: Percentage of Participants With Human Serum Bactericidal Activity (hSBA) Titer >=1:8 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination	Month 1	Percentage of participants with hSBA titer \>=1.8 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.
Vaccine Sub-study: Percentage of Participants With hSBA Titer >=1:4 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination	Month 1	Percentage of participants with hSBA titer \>=1.4 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.
Vaccine Sub-study: Geometric Mean Titers (GMT) of Antibodies for Serogroup C at Baseline and Month 1-Meningococcal ACWY Vaccination	Baseline (pre-vaccination on Day 1) and Month 1	Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\* LLOQ.
Vaccine Sub-study: Number of Participants With SAEs	From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events.
Vaccine Sub-study: Number of Participants With AEs	From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Vaccine Sub-study: Number of Participants With AEs Leading to Discontinuation	From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.

Trial Locations

Locations (143): The University of Alabama at Birmingham Hosptial Outreach Lab
🇺🇸
Birmingham, Alabama, United States
The University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
The University of Alabama at Birmingham, Department of Dermatology
🇺🇸
Birmingham, Alabama, United States
Mosaic Dermatology
🇺🇸
Beverly Hills, California, United States
Univ of California, Irvine, Dermatology Clinical Research Center
🇺🇸
Irvine, California, United States
Dermatology Specialists Inc.
🇺🇸
Murrieta, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Kaiser Permanente Clinical Trials Unit
🇺🇸
San Francisco, California, United States
Southern California Dermatology, Inc.
🇺🇸
Santa Ana, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸
Aurora, Colorado, United States
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The University of Alabama at Birmingham Hosptial Outreach Lab
🇺🇸Birmingham, Alabama, United States