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Comparison · NCT04006457-8992f4db

Vaccine Sub-study: Tdap Vaccination vs Vaccine Sub-study: Meningococcal ACWY Vaccination: Vaccine Sub-study: Number of Participants With SAEs

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Vaccine Sub-study: Tdap Vaccination vs Vaccine Sub-study: Meningococcal ACWY Vaccination: Vaccine Sub-study: Number of Participants With SAEs. Trial comparisons, record NCT04006457-8992f4db. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04006457-8992f4db

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.184wilson
Risk in group 2000.228wilson
Risk difference, group 1 minus group 20-0.2280.184newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Vaccine Sub-study: Tdap Vaccination
Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.
017OG000
Group 2Vaccine Sub-study: Meningococcal ACWY Vaccination
Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.
013OG001

Outcome

Type
SECONDARY
Title
Vaccine Sub-study: Number of Participants With SAEs
Description
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).

Source ClinicalTrials.gov

Trial

Title
Long-Term PF-06651600 for the Treatment of Alopecia Areata
NCT number
NCT04006457
Phases
PHASE3
Conditions
Alopecia Areata
Interventions
PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Lead sponsor
Pfizer
Results first posted
2025-08-14

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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