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

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.

Time frame: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

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.

Time frame: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention. Here, the Overall number of participants analyzed signifies the total number of participants evaluable for laboratory abnormalities, i.e. the number with at least one observation of the given laboratory test while on study treatment or during lag time (35 days after the last dose).

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.

Time frame: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention.

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.

Time frame: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention.

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.

Time frame: Month 1

Population: Safety Analysis Set (SAS) was defined as all participants from this sub-study who received at least 1 vaccine (Tdap or meningococcal ACWY). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

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).

Time frame: Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From start of study intervention (Day 1) until end of study

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.

Time frame: At Months 1, 3, 6, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Number of Participants Analyzed included all participants from FAS without normal EBA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed included all participants from FAS without normal ELA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Overall Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: Full Analysis Set (FAS) was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed included all participants from the FAS with a score indicative of anxiety at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS included was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed included all participants from the FAS with a score indicative of depression at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. Participants reported under Overall Number of Participants Analyzed included all participants from FAS who had an AAPPO baseline score \>=2 who contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.

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.

Time frame: Month 1

Population: FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: From Baseline (pre-vaccination on Day 1) to Month 1

Population: FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: Baseline (pre-vaccination on Day 1) and Month 1

Population: FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Population: SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).

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.

Time frame: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Population: SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).

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.

Time frame: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Population: SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).

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.

Time frame: Month 1

Population: FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: Month 1

Population: FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: Month 1

Population: FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: Month 1

Population: FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

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.

Time frame: Month 1

Population: FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.