Trial Outcomes & Findings for A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo (NCT NCT01359150)

Last Updated: 2013-03-29

Results Overview

Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (\>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

223 participants

Primary outcome timeframe

Day 64 (End of Study [EOS])

Results posted on

2013-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Study STARTED	112	111
Overall Study COMPLETED	105	106
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Study Lack of Efficacy	1	1
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	4	3
Overall Study Other	1	0

Baseline Characteristics

A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=112 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=111 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Total n=223 Participants Total of all reporting groups
Age Continuous	52.7 years STANDARD_DEVIATION 10.4 • n=5 Participants	52.2 years STANDARD_DEVIATION 11.1 • n=7 Participants	52.4 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	90 Participants n=7 Participants	171 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	21 Participants n=7 Participants	52 Participants n=5 Participants
Number of Participants With Background (BG) Methotrexate (MTX) use With Background MTX use	62 participants n=5 Participants	62 participants n=7 Participants	124 participants n=5 Participants
Number of Participants With Background (BG) Methotrexate (MTX) use Without Background MTX use	50 participants n=5 Participants	49 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 64 (End of Study [EOS])

Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) Regardless MTX use (n=102,98)	45.1 percentage of participants Interval 35.224 to 55.264	68.4 percentage of participants Interval 58.196 to 77.394
Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) With BG MTX use (n=57,55)	31.6 percentage of participants Interval 19.905 to 45.243	61.8 percentage of participants Interval 47.726 to 74.591
Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) Without BG MTX use (n=45,43)	62.2 percentage of participants Interval 46.541 to 76.232	76.7 percentage of participants Interval 61.369 to 88.245

PRIMARY outcome

Timeframe: Day 64 (EOS)

Satisfactory humoral response to the influenza vaccine was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) Regardless MTX use (n=102,98)	56.9 percentage of participants Interval 46.682 to 66.634	62.2 percentage of participants Interval 51.885 to 71.844
Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) With BG MTX use (n=57,55)	50.9 percentage of participants Interval 37.29 to 64.37	58.2 percentage of participants Interval 44.106 to 71.345
Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) Without BG MTX use (n=45,43)	64.4 percentage of participants Interval 48.78 to 78.132	67.4 percentage of participants Interval 51.456 to 80.924

SECONDARY outcome

Timeframe: Day 64 (EOS)

Response to the pneumococcal vaccine (seroconversion) was defined as \>= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 1 (n=102,98)	59.8 percentage of participants Interval 49.63 to 69.393	69.4 percentage of participants Interval 59.265 to 78.302
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 14 (n=102,98)	52 percentage of participants Interval 41.844 to 61.961	61.2 percentage of participants Interval 50.849 to 70.903
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 18C (n=102,98)	59.8 percentage of participants Interval 49.63 to 69.393	70.4 percentage of participants Interval 60.338 to 79.205
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 19A (n=102,98)	32.4 percentage of participants Interval 23.424 to 42.337	46.9 percentage of participants Interval 36.778 to 57.289
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 19F (n=102,98)	35.3 percentage of participants Interval 26.086 to 45.38	56.1 percentage of participants Interval 45.732 to 66.133
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 23F (n=102,98)	40.2 percentage of participants Interval 30.607 to 50.37	58.2 percentage of participants Interval 47.766 to 68.054
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 3 (n=102,98)	38.2 percentage of participants Interval 28.787 to 48.386	54.1 percentage of participants Interval 43.714 to 64.196
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 4 (n=102,98)	58.8 percentage of participants Interval 48.644 to 68.477	65.3 percentage of participants Interval 55.02 to 74.64
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 5 (n=102,98)	28.4 percentage of participants Interval 19.938 to 38.218	38.8 percentage of participants Interval 29.097 to 49.151
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 6B (n=102,98)	36.3 percentage of participants Interval 26.982 to 46.386	54.1 percentage of participants Interval 43.714 to 64.196
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 7F (n=102,98)	58.8 percentage of participants Interval 48.644 to 68.477	65.3 percentage of participants Interval 55.02 to 74.64
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Regardless MTX use, 9V (n=102,98)	45.1 percentage of participants Interval 35.224 to 55.264	58.2 percentage of participants Interval 47.766 to 68.054
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 1 (n=57,55)	57.9 percentage of participants Interval 44.084 to 70.857	61.8 percentage of participants Interval 47.726 to 74.591
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 14 (n=57,55)	47.4 percentage of participants Interval 33.985 to 61.035	56.4 percentage of participants Interval 42.322 to 69.696
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 18C (n=57,55)	49.1 percentage of participants Interval 35.63 to 62.71	58.2 percentage of participants Interval 44.106 to 71.345
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 19A (n=57,55)	19.3 percentage of participants Interval 10.047 to 31.911	40 percentage of participants Interval 27.023 to 54.093
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 19F (n=57,55)	28.1 percentage of participants Interval 16.973 to 41.543	49.1 percentage of participants Interval 35.354 to 62.929
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 23F (n=57,55)	24.6 percentage of participants Interval 14.127 to 37.761	49.1 percentage of participants Interval 35.354 to 62.929
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 3 (n=57,55)	24.6 percentage of participants Interval 14.127 to 37.761	49.1 percentage of participants Interval 35.354 to 62.929
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 4 (n=57,55)	52.6 percentage of participants Interval 38.965 to 66.015	56.4 percentage of participants Interval 42.322 to 69.696
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 5 (n=57,55)	28.1 percentage of participants Interval 16.973 to 41.543	29.1 percentage of participants Interval 17.63 to 42.898
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 6B (n=57,55)	29.8 percentage of participants Interval 18.429 to 43.403	47.3 percentage of participants Interval 33.653 to 61.196
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 7F (n=57,55)	49.1 percentage of participants Interval 35.63 to 62.71	56.4 percentage of participants Interval 42.322 to 69.696
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens With BG MTX use, 9V (n=57,55)	33.3 percentage of participants Interval 21.401 to 47.065	49.1 percentage of participants Interval 35.354 to 62.929
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 1 (n=45,43)	62.2 percentage of participants Interval 46.541 to 76.232	79.1 percentage of participants Interval 63.958 to 89.956
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 14 (n=45,43)	57.8 percentage of participants Interval 42.15 to 72.343	67.4 percentage of participants Interval 51.456 to 80.924
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 18C (n=45,43)	73.3 percentage of participants Interval 58.055 to 85.396	86 percentage of participants Interval 72.068 to 94.702
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 19A (n=45,43)	48.9 percentage of participants Interval 33.703 to 64.226	55.8 percentage of participants Interval 39.875 to 70.922
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 19F (n=45,43)	44.4 percentage of participants Interval 29.644 to 60.003	65.1 percentage of participants Interval 49.073 to 78.992
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 23F (n=45,43)	60 percentage of participants Interval 44.331 to 74.302	69.8 percentage of participants Interval 53.875 to 82.818
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 3 (n=45,43)	55.6 percentage of participants Interval 39.997 to 70.356	60.5 percentage of participants Interval 44.41 to 75.023
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 4 (n=45,43)	66.7 percentage of participants Interval 51.05 to 79.999	76.7 percentage of participants Interval 61.369 to 88.245
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 5 (n=45,43)	28.9 percentage of participants Interval 16.366 to 44.315	51.2 percentage of participants Interval 35.465 to 66.695
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 6B (n=45,43)	44.4 percentage of participants Interval 29.644 to 60.003	62.8 percentage of participants Interval 46.725 to 77.025
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 7F (n=45,43)	71.1 percentage of participants Interval 55.685 to 83.634	76.7 percentage of participants Interval 61.369 to 88.245
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens Without BG MTX use, 9V (n=45,43)	60 percentage of participants Interval 44.331 to 74.302	69.8 percentage of participants Interval 53.875 to 82.818

SECONDARY outcome

Timeframe: Day 64 (EOS)

Response to the influenza vaccine (seroconversion) was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens Regardless MTX use, B (n=102,98)	38.2 percentage of participants Interval 28.787 to 48.386	52 percentage of participants Interval 41.712 to 62.243
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens Regardless MTX use, H1N1 (n=102,98)	60.8 percentage of participants Interval 50.62 to 70.305	63.3 percentage of participants Interval 52.925 to 72.781
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens Regardless MTX use, H3N2 (n=102,98)	60.8 percentage of participants Interval 50.62 to 70.305	69.4 percentage of participants Interval 59.265 to 78.302
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens With BG MTX use, B (n=57,55)	35.1 percentage of participants Interval 22.915 to 48.869	41.8 percentage of participants Interval 28.655 to 55.894
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens With BG MTX use, H1N1 (n=57,55)	52.6 percentage of participants Interval 38.965 to 66.015	58.2 percentage of participants Interval 44.106 to 71.345
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens With BG MTX use, H3N2 (n=57,55)	57.9 percentage of participants Interval 44.084 to 70.857	65.5 percentage of participants Interval 51.419 to 77.763
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens Without BG MTX use, B (n=45,43)	42.2 percentage of participants Interval 27.657 to 57.85	65.1 percentage of participants Interval 49.073 to 78.992
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens Without BG MTX use, H1N1 (n=45,43)	71.1 percentage of participants Interval 55.685 to 83.634	69.8 percentage of participants Interval 53.875 to 82.818
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens Without BG MTX use, H3N2 (n=45,43)	64.4 percentage of participants Interval 48.78 to 78.132	74.4 percentage of participants Interval 58.828 to 86.481

SECONDARY outcome

Timeframe: Day 64 (EOS)

Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of \>= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine Regardless MTX use (n=102,98)	76.5 percentage of participants Interval 67.043 to 84.305	91.8 percentage of participants Interval 84.547 to 96.41
Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine With BG MTX use (n=57,55)	64.9 percentage of participants Interval 51.131 to 77.085	92.7 percentage of participants Interval 82.413 to 97.983
Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine Without BG MTX use (n=45,43)	91.1 percentage of participants Interval 78.779 to 97.525	90.7 percentage of participants Interval 77.865 to 97.407

SECONDARY outcome

Timeframe: Day 64 (EOS)

Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 1 (n=89,92)	4.75 fold rise Interval 3.61 to 6.24	6.83 fold rise Interval 4.94 to 9.46
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 14 (n=101,96)	2.68 fold rise Interval 2.19 to 3.28	3.90 fold rise Interval 3.05 to 4.99
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 18C (n=101,98)	3.10 fold rise Interval 2.52 to 3.81	4.82 fold rise Interval 3.76 to 6.18
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 19A (n=102,98)	1.80 fold rise Interval 1.56 to 2.08	2.34 fold rise Interval 1.99 to 2.75
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 19F (n=102,95)	2.04 fold rise Interval 1.71 to 2.42	2.89 fold rise Interval 2.4 to 3.49
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 23F (n=102,98)	2.00 fold rise Interval 1.64 to 2.44	2.81 fold rise Interval 2.34 to 3.36
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 3 (n=101,94)	2.11 fold rise Interval 1.76 to 2.54	2.79 fold rise Interval 2.31 to 3.38
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 4 (n=96,89)	3.10 fold rise Interval 2.49 to 3.86	5.13 fold rise Interval 3.94 to 6.67
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 5 (n=101,98)	1.72 fold rise Interval 1.5 to 1.97	2.27 fold rise Interval 1.91 to 2.7
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 6B (n=102,98)	1.90 fold rise Interval 1.61 to 2.24	2.56 fold rise Interval 2.12 to 3.1
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 7F (n=102,97)	3.19 fold rise Interval 2.59 to 3.93	4.06 fold rise Interval 3.27 to 5.04
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, 9V (n=102,98)	2.27 fold rise Interval 1.85 to 2.55	3.16 fold rise Interval 2.59 to 3.86
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 1 (n=49,53)	3.92 fold rise Interval 2.77 to 5.54	4.51 fold rise Interval 3.0 to 6.77
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 14 (n=56,54)	2.37 fold rise Interval 1.84 to 3.04	2.85 fold rise Interval 2.19 to 3.72
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 18C (n=57,55)	2.64 fold rise Interval 2.05 to 3.41	3.23 fold rise Interval 2.45 to 4.26
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 19A (n=57,55)	1.51 fold rise Interval 1.3 to 1.74	2.08 fold rise Interval 1.67 to 2.59
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 19F (n=57,53)	1.92 fold rise Interval 1.51 to 2.44	2.29 fold rise Interval 1.88 to 2.79
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 23F (n=57,55)	1.66 fold rise Interval 1.32 to 2.07	2.34 fold rise Interval 1.88 to 2.91
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 3 (n=56,54)	1.78 fold rise Interval 1.39 to 2.27	2.43 fold rise Interval 1.9 to 3.12
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 4 (n=53,50)	2.92 fold rise Interval 2.22 to 3.85	3.27 fold rise Interval 2.51 to 4.25
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 5 (n=57,55)	1.62 fold rise Interval 1.35 to 1.95	1.99 fold rise Interval 1.59 to 2.5
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 6B (n=57,55)	1.60 fold rise Interval 1.37 to 1.88	2.24 fold rise Interval 1.79 to 2.81
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 7F (n=57,55)	2.38 fold rise Interval 1.89 to 2.98	3.46 fold rise Interval 2.57 to 4.64
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, 9V (n=57,55)	1.87 fold rise Interval 1.53 to 2.29	2.72 fold rise Interval 2.08 to 3.54
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 1 (n=40,39)	6.01 fold rise Interval 3.85 to 9.37	12.04 fold rise Interval 7.34 to 19.74
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 14 (n=45,42)	3.14 fold rise Interval 2.25 to 4.37	5.85 fold rise Interval 3.81 to 8.99
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 18C (n=44,43)	3.80 fold rise Interval 2.7 to 5.35	8.05 fold rise Interval 5.37 to 12.08
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 19A (n=45,43)	2.27 fold rise Interval 1.75 to 2.94	2.72 fold rise Interval 2.13 to 3.47
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 19F (n=45,42)	2.19 fold rise Interval 1.68 to 2.85	3.88 fold rise Interval 2.78 to 5.43
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 23F (n=45,43)	2.54 fold rise Interval 1.81 to 3.58	3.55 fold rise Interval 2.63 to 4.78
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 3 (n=45,40)	2.61 fold rise Interval 1.98 to 3.44	3.37 fold rise Interval 2.49 to 4.55
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 4 (n=43,39)	3.32 fold rise Interval 2.31 to 4.79	9.15 fold rise Interval 5.85 to 14.29
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 5 (n=44,43)	1.86 fold rise Interval 1.5 to 2.29	2.68 fold rise Interval 2.04 to 3.52
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 6B (n=45,43)	2.36 fold rise Interval 1.73 to 3.21	3.04 fold rise Interval 2.19 to 4.21
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 7F (n=45,42)	4.62 fold rise Interval 3.23 to 6.6	5.02 fold rise Interval 3.65 to 6.9
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, 9V (n=45,43)	2.63 fold rise Interval 2.03 to 3.41	3.83 fold rise Interval 2.82 to 5.19

SECONDARY outcome

Timeframe: Day 64 (EOS)

GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, B (n=102,98)	2.95 fold rise Interval 2.32 to 3.75	3.90 fold rise Interval 3.06 to 4.97
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, H1N1 (n=102,98)	6.04 fold rise Interval 4.59 to 7.95	9.50 fold rise Interval 6.76 to 13.35
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) Regardless MTX use, H3N2 (n=102,98)	7.11 fold rise Interval 5.18 to 9.75	9.06 fold rise Interval 6.61 to 12.44
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, B (n=57,55)	2.84 fold rise Interval 2.02 to 3.98	3.11 fold rise Interval 2.27 to 4.26
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, H1N1 (n=57,55)	4.90 fold rise Interval 3.43 to 7.0	7.54 fold rise Interval 4.8 to 11.85
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) With BG MTX use, H3N2 (n=57,55)	5.69 fold rise Interval 3.88 to 8.34	6.04 fold rise Interval 4.18 to 8.73
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, B (n=45,43)	3.11 fold rise Interval 2.2 to 4.4	5.20 fold rise Interval 3.57 to 7.57
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, H1N1 (n=45,43)	7.88 fold rise Interval 5.13 to 12.1	12.76 fold rise Interval 7.56 to 21.53
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) Without BG MTX use, H3N2 (n=45,43)	9.43 fold rise Interval 5.52 to 16.09	15.25 fold rise Interval 9.06 to 25.66

SECONDARY outcome

Timeframe: Day 64 (EOS)

Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 1	1.81 microgram/milliliter (mcg/mL) Interval 1.32 to 2.48	3.27 microgram/milliliter (mcg/mL) Interval 2.34 to 4.58
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 14	5.24 microgram/milliliter (mcg/mL) Interval 3.85 to 7.12	6.40 microgram/milliliter (mcg/mL) Interval 4.63 to 8.84
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 18C	2.53 microgram/milliliter (mcg/mL) Interval 1.95 to 3.29	4.60 microgram/milliliter (mcg/mL) Interval 3.48 to 6.09
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 19A	5.21 microgram/milliliter (mcg/mL) Interval 4.15 to 6.54	8.57 microgram/milliliter (mcg/mL) Interval 6.86 to 10.7
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 19F	2.59 microgram/milliliter (mcg/mL) Interval 1.93 to 3.47	3.09 microgram/milliliter (mcg/mL) Interval 2.28 to 4.19
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 23F	2.41 microgram/milliliter (mcg/mL) Interval 1.86 to 3.11	3.55 microgram/milliliter (mcg/mL) Interval 2.78 to 4.55
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 3	0.66 microgram/milliliter (mcg/mL) Interval 0.52 to 0.86	1.11 microgram/milliliter (mcg/mL) Interval 0.86 to 1.43
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 4	0.72 microgram/milliliter (mcg/mL) Interval 0.54 to 0.97	1.07 microgram/milliliter (mcg/mL) Interval 0.77 to 1.48
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 5	4.05 microgram/milliliter (mcg/mL) Interval 3.23 to 5.09	5.79 microgram/milliliter (mcg/mL) Interval 4.6 to 7.3
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 6B	2.99 microgram/milliliter (mcg/mL) Interval 2.34 to 3.83	4.75 microgram/milliliter (mcg/mL) Interval 3.71 to 6.07
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 7F	3.28 microgram/milliliter (mcg/mL) Interval 2.42 to 4.45	4.37 microgram/milliliter (mcg/mL) Interval 3.36 to 5.67
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody 9V	2.61 microgram/milliliter (mcg/mL) Interval 2.11 to 3.23	4.06 microgram/milliliter (mcg/mL) Interval 3.29 to 5.01

SECONDARY outcome

Timeframe: Day 64 (EOS)

Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.

Outcome measures

Outcome measures
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=102 Participants CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=98 Participants Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Geometric Mean Titer (GMT) of Anti-Influenza Antibody B	33.39 titer Interval 25.61 to 43.54	50.74 titer Interval 39.82 to 64.64
Geometric Mean Titer (GMT) of Anti-Influenza Antibody H1N1	86.40 titer Interval 64.35 to 116.0	221.5 titer Interval 161.4 to 304.0
Geometric Mean Titer (GMT) of Anti-Influenza Antibody H3N2	132.3 titer Interval 97.65 to 179.1	244.0 titer Interval 184.6 to 322.5

Adverse Events

CP-690,550 + Influenza and Pneumococcal Vaccine

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo + Influenza and Pneumococcal Vaccine

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=112 participants at risk CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=111 participants at risk Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Cardiac disorders Atrial fibrillation	0.89% 1/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.89% 1/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.00% 0/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.90% 1/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.89% 1/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.89% 1/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	CP-690,550 + Influenza and Pneumococcal Vaccine n=112 participants at risk CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.	Placebo + Influenza and Pneumococcal Vaccine n=111 participants at risk Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Gastrointestinal disorders Diarrhoea	0.89% 1/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 4/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	5.4% 6/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.2% 8/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	2.7% 3/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 4/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 3/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	2.7% 3/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	4.5% 5/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.90% 1/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.7% 3/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/111 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER