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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04887948 |
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Full text link
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
ClinicalTrials.gov_Inquiries@pfizer.com |
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Registration date
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-14 |
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Recruitment status
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - male or female participants ≥65 years of age at the time of consent - participating or participated in study c4591001, received 2 doses of 30 µg bnt162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of bnt162b2 - adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease - adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study |
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Exclusion criteria
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) - serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study - previous clinical or microbiological diagnosis of covid-19 - previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation - previous vaccination with any coronavirus vaccine, other than those received in study c4591001 - other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study |
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Number of arms
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Pfizer |
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Inclusion age min
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
65 |
|
Inclusion age max
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 17, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 27, 2022, 4 p.m. Source : ClinicalTrials.gov |
570 |
|
primary outcome
Last imported at : Dec. 15, 2022, noon Source : ClinicalTrials.gov |
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination;Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination;Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination;Percentage of Participants With Systemic Events Within 7 Days After Vaccination |
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Notes
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : May 16, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "1+1 (coadministration);received 2 doses of 30 \u00b5g BNT162b2 prior", "treatment_id": 1432, "treatment_name": "Bnt162b2+pneumococcal vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "1;received 2 doses of 30 \u00b5g BNT162b2 prior", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;received 2 doses of 30 \u00b5g BNT162b2 prior", "treatment_id": 1006, "treatment_name": "Pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |