N/A
N=53,902
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01128426 ↗Enrolled (actual)
53,902
Serious AEs
—
Results posted
Jul 2014
Primary outcome: Primary: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient — 0.98; 0.46; 0.98; 0.30 ratio — p=0.98
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient |
0.98; 0.46; 0.98; 0.30; 0.49; 1.18 | 0.98 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department |
1.97; 0.27; 2.75; NA; 0.98; NA | 0.63 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined |
1.23; 0.45; 0.98; 1.19; 0.49; 0.98 | 0.77 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient |
NA; 2.65; 0.91; 0.91; 1.14; NA | 0.14 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department |
0.61; 0.68; 0.61; NA; NA; 3.19 | 0.62 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined |
1.52; 1.93; 0.91; 0.70; 1.14; NA | 0.59 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient |
4.65; 1.06; 0.93; 0.53; NA; NA | 0.15 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department |
NA; 2.79; 0.57; 0.93; NA; 0.31 | 0.27 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined |
6.51; 1.45; 0.93; 0.55; NA; 0.93 | 0.05 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient |
1.97; 1.15; NA; 1.38; 2.95; NA | 0 .63 sig |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department |
NA; 0.84; NA; 0.90; NA; 0.49 | 0.50 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined |
2.95; 1.10; 4.92; 0.95; 3.93; 0.49 | 0.38 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient |
4.69; 1.57; 3.29; 0.88; 1.88; 6.57 | 0.03 sig |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department |
1.56; 1.27; NA; 0.73; NA; 0.94 | 0.56 |
| PRIMARY Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined |
2.82; 1.50; 2.19; 0.75; 2.07; 0.94 | 0.04 sig |
Summary
The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.
Eligibility Criteria
Inclusion Criteria
- Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.
Exclusion Criteria
- Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.
Data sourced from ClinicalTrials.gov (NCT01128426). 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.