Adult Not Younger Than 65 Years
Conditions
Brief summary
This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older). 1. To confirm the use in actual clinical settings 2. To confirm the occurrence of adverse events
Detailed description
This study is a multicenter open-label cohort conducted in patients vaccinated with the Product; for which, case report forms will be recorded based on data presented in medical records obtained from day-to-day clinical treatment and diagnosis. Pneumococcal vaccine health study diary will be implemented to collect accurate safety data; to which, vaccine recipients will be asked directly to cooperate.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Geriatric patients vaccinated with this product (adult not younger than 65 years) 2. Consent of vaccine recipients \[Vaccine recipient (or his/her legally acceptable representative) must sign and date the consent form warranting that the relevant information concerning this Study was appropriately communicated to the recipient\].
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Reactions | 28 days | An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence attributed to Prevenar 13 in a participant who received Prevenar 13. A serious adverse reaction was a vaccine-related adverse event 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. Relatedness to Prevenar 13 was assessed by the physician. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days. | 684 |
| Total | 684 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Registration Violation | 12 |
Baseline characteristics
| Characteristic | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| Age, Customized ≥65 and <70 years | 127 Participants |
| Age, Customized <65 years | 0 Participants |
| Age, Customized ≥70 and <75 years | 157 Participants |
| Age, Customized ≥75 and <80 years | 154 Participants |
| Age, Customized ≥80 and <85 years | 134 Participants |
| Age, Customized ≥85 years | 112 Participants |
| Race/Ethnicity, Customized Asian | 684 Participants |
| Sex/Gender, Customized Female | 385 Participants |
| Sex/Gender, Customized Male | 299 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 684 |
| other Total, other adverse events | 85 / 684 |
| serious Total, serious adverse events | 6 / 684 |
Outcome results
Primary
Number of Participants With Adverse Reactions
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence attributed to Prevenar 13 in a participant who received Prevenar 13. A serious adverse reaction was a vaccine-related adverse event 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. Relatedness to Prevenar 13 was assessed by the physician.
Time frame: 28 days
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and provided the safety data after vaccination with Prevenar 13.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) | Number of Participants With Adverse Reactions | Adverse Reactions | 80 Participants |
| Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) | Number of Participants With Adverse Reactions | Serious Adverse Reactions | 1 Participants |