An observational study in Adult Not Younger Than 65 Years, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Pfizer · Observational
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).
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Geriatric patients vaccinated with this product (adult not younger than 65 years)
Exclusion Criteria:
None
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
| Milestone | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| Started | 696 |
| Completed | 684 |
| Not completed | 12 |
| Withdrew: Registration violation | 12 |
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.
| Participants | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| Adverse Reactions | 80 |
| Serious Adverse Reactions | 1 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) | 0/684 (0%) | 6/684 (0.9%) | 85/684 (12.4%) |
| Event | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| PneumoniaInfections and infestations | 1/684 |
| Vaccination site cellulitisInfections and infestations | 1/684 |
| Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/684 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/684 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/684 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/684 |
| Event | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| Vaccination site swellingGeneral disorders | 36/684 |
| Vaccination site erythemaGeneral disorders | 35/684 |
| Vaccination site painGeneral disorders | 34/684 |
| PyrexiaGeneral disorders | 10/684 |
| Vaccination site pruritusGeneral disorders | 6/684 |
| MalaiseGeneral disorders | 2/684 |
| NauseaGastrointestinal disorders | 1/684 |
| Injection site hypoaesthesiaGeneral disorders | 1/684 |
| PneumoniaInfections and infestations | 1/684 |
| Urinary tract infectionInfections and infestations | 1/684 |
A total of 696 participants were enrolled in this study. Of the 696 participants, 12 participants were excluded from the baseline analysis due to registration violation.
| Age, Customized(Participants) | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| <65 years | 0 |
| ≥65 and <70 years | 127 |
| ≥70 and <75 years | 157 |
| ≥75 and <80 years | 154 |
| ≥80 and <85 years | 134 |
| ≥85 years | 112 |
| Sex/Gender, Customized(Participants) | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| Female | 385 |
| Male | 299 |
| Race/Ethnicity, Customized(Participants) | Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) |
|---|---|
| Asian | 684 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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