Infants
Conditions
Brief 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.
Detailed description
The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.
Interventions
DRUGPrevenar (13v)
Prevenar (13v)
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Reactions | The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination. | An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevenar 13 Participants were vaccinated with Prevenar 13 as follows: for primary immunization, three doses of Prevenar 13 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL was injected subcutaneously, at least 60 days after the third dose. | 1,071 |
| Total | 1,071 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 16 |
Baseline characteristics
| Characteristic | Prevenar 13 |
|---|---|
| Age, Customized 2 to less than 3 months | 937 Participants |
| Age, Customized 3 to less than 4 months | 106 Participants |
| Age, Customized 4 to less than 5 months | 21 Participants |
| Age, Customized 5 to less than 6 months | 4 Participants |
| Age, Customized 6 to less than 7 months | 3 Participants |
| Sex: Female, Male Female | 501 Participants |
| Sex: Female, Male Male | 570 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,026 / 1,071 |
| serious Total, serious adverse events | 11 / 1,071 |
Outcome results
Primary
Number of Participants With Adverse Reactions
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
Time frame: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
Population: The safety analysis population comprised of participants who had received Prevenar 13 at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar 13 | Number of Participants With Adverse Reactions | Adverse Reactions | 432 Participants |
| Prevenar 13 | Number of Participants With Adverse Reactions | Serious Adverse Reactions | 3 Participants |