N/A
N=327,293
Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine
Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT00258882 ↗Enrolled (actual)
327,293
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database — 0 Events Per 1000 Person-months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tetanus Toxoid, acellular pertussis, diphtheria toxoid (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database |
— | — |
| PRIMARY Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database |
0; 0 | — |
| PRIMARY All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. |
— | — |
| PRIMARY All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases. |
— | — |
| PRIMARY Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls |
165; 442; 21; 102; 0; 1 | — |
| PRIMARY Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls. |
1; 0; 4; 18; 1; 2 | — |
Summary
To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
Eligibility Criteria
Inclusion Criteria
- Receipt of ADACEL vaccine during the study period
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00258882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.