N/A
Completed N=53,902
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Source: ClinicalTrials.gov NCT01128426 ↗Enrolled (actual)
53,902
Serious AEs
—
Results posted
Jul 2014
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.