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NCT05794191 · ClinicalTrials.gov registry record
A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 350,399
- Enrollment target
NCT05794191: Completed study, sponsored by Pfizer.
NCT05794191 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 350,399 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05794191 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 350,399 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV. The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the bloodstream. All participants in the study will be identified in health care databases. Adults with HIV will be identified by looking for a medical diagnosis that has confirmed HIV from the databases. Vaccination will be identified in the databases by looking for vaccine administration or for PCV13. Participants will be followed in the databases to see if they have one of the diseases mentioned above or not. The number of vaccinated participants with the diseases will be compared to the number participants without the vaccines but with the diseases. This will help to understand how well the vaccine worked.
Primary Outcome
VE:\[(1-hazard ratio (HR)\]\*100 and was obtained from marginal structural Cox models(Cox-MSM) after applying Inverse probability of treatment (IPT)\*Inverse probability of censoring(IPC)weights.IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD: based on International Classification of Disease
Interventions
- BIOLOGICAL Vaccine Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350,399 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2024-08-15 |
What the finished NCT05794191 record still lists
NCT05794191 is an observational study that tracks outcomes without assigning an intervention. Its 350,399 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Vaccine Administration is the first listed.
NCT05794191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05794191 about?
NCT05794191 is a clinical study titled "A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV". The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV. The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the blood...
What is the current status of trial NCT05794191?
This trial is currently completed. The enrollment target is 350,399 participants. The study started on 2023-03-22. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT05794191?
The interventions under investigation include: Vaccine Administration (BIOLOGICAL).
Who is sponsoring clinical trial NCT05794191?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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