N/A
N=1,087
Prevenar (13v) Infant Drug Use Investigation
Infants
Bottom Line
View on ClinicalTrials.gov: NCT02119104 ↗Enrolled (actual)
1,087
Serious AEs
1.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Adverse Reactions — 432; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prevenar (13v) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reactions |
432; 3 | — |
Summary
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.
Eligibility Criteria
Inclusion Criteria
- Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
- Infants aged 2 months, inclusive, to 7 months, exclusive
- Infants with no history of administration of pneumococcal vaccines including Prevenar 13
- Infants expected to receive 4 vaccinations
Exclusion Criteria
- Vaccines must not be performed if the vaccinee corresponds to any of the following:
- Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
- Persons with evident pyrexia
- Persons who evidently have serious acute diseases
- Besides the persons listed above, persons who are in a status inappropriate for immunization
Data sourced from ClinicalTrials.gov (NCT02119104). 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.