Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Brief summary
To collect post-marketing information on the safety of Prevenar in Filipino patients
Interventions
BIOLOGICALPneumococcal Conjugate Vaccine, 7-valent (Prevenar)
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.
Exclusion criteria
* Previously discontinued Prevenar therapy due to safety concerns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Spontaneous Adverse Events | 30 days post injection up to 3 years |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevenar 7v Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection | 3,366 |
| Total | 3,366 |
Baseline characteristics
| Characteristic | Prevenar 7v |
|---|---|
| Age Continuous | 43.6 weeks STANDARD_DEVIATION 50.9 |
| Sex: Female, Male Female | 1576 Participants |
| Sex: Female, Male Male | 1790 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 88 / 3,366 |
| serious Total, serious adverse events | 3 / 3,366 |
Outcome results
Primary
Number of Participants With Spontaneous Adverse Events
Time frame: 30 days post injection up to 3 years
Population: Safety Analysis set - all participants who received at least one dose of Prevenar
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar 7v | Number of Participants With Spontaneous Adverse Events | 91 Participants |