Pneumococcal Disease
Conditions
Brief summary
Prevenar 13 is safe for administration to Filipinos.
Detailed description
Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.
Interventions
BIOLOGICALPrevenar 13
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients prescribed with the vaccine
Exclusion criteria
Patients with hypersensitivity to the vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC (Prevenar 13), Cohort 1 Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age. | 2,817 |
| 13vPnC (Prevenar 13), Cohort 2 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older. | 175 |
| 13vPnC (Prevenar 13), Cohort 3 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group. | 14 |
| Total | 3,006 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Other | 10 | 0 | 0 |
Baseline characteristics
| Characteristic | 13vPnC (Prevenar 13), Cohort 2 | 13vPnC (Prevenar 13), Cohort 3 | 13vPnC (Prevenar 13), Cohort 1 | Total |
|---|---|---|---|---|
| Age, Continuous Age at enrollment (years) | 65.1 years STANDARD_DEVIATION 10.6 | 0.7 years STANDARD_DEVIATION 1.54 | 0.5 years STANDARD_DEVIATION 0.94 | 4.3 years STANDARD_DEVIATION 15.37 |
| Gender Female | 115 Participants | 6 Participants | 1402 Participants | 1523 Participants |
| Gender Male | 60 Participants | 8 Participants | 1415 Participants | 1483 Participants |
| Race/Ethnicity, Customized Asian | 175 participants | 14 participants | 2783 participants | 2972 participants |
| Race/Ethnicity, Customized Black | 0 participants | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 24 participants | 24 participants |
| Race/Ethnicity, Customized White | 0 participants | 0 participants | 8 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 68 / 2,817 | 5 / 175 | 0 / 14 |
| serious Total, serious adverse events | 1 / 2,817 | 0 / 175 | 0 / 14 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.
Time frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
Population: Participants who received at least 1 dose of 13vPnC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC (Prevenar 13), Cohort 1 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 68 participants |
| 13vPnC (Prevenar 13), Cohort 1 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| 13vPnC (Prevenar 13), Cohort 2 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 participants |
| 13vPnC (Prevenar 13), Cohort 2 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| 13vPnC (Prevenar 13), Cohort 3 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 participants |
| 13vPnC (Prevenar 13), Cohort 3 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |