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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06622109 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.
This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.
Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.
Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.
The side effects observed in the participants will be recorded and looked into.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20-valent Pneumococcal Conjugate Vaccine | Infants aged 2 months, inclusive to 7 months, exclusive who have been vaccinated with PREVENAR 20 for the first time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-valent Pneumococcal Conjugate Vaccine | Biological | Injection in the muscle or subcutaneous , 1 dose 0.5mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Adverse Reactions(ADRs) | From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th). | |
| Percentage of Participants Reporting Serious Adverse Reactions (SADRs) | From the first day of 1st vaccination up to 28 days after 4th vaccination. |
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Inclusion Criteria:
Exclusion Criteria:There are no exclusion criteria for this study.
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Infants aged 2 months, inclusive, to 7 months, exclusive who PREVENAR 20 for the first time.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Tokyo | 151-8589 | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| D007239 | Infections |