A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV

NCT ID: NCT05794191

Last Updated: 2025-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Pneumonia Infections, Pneumococcal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Persons living with HIV (PLWH)

Adults with HIV

Vaccine Administration

Intervention Type BIOLOGICAL

PCV13 administration

Interventions

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Vaccine Administration

PCV13 administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. HIV infection defined as at least one inpatient or ≥2 outpatient codes related to HIV at least 30 days but no more than 730 days apart
2. At least 18 years of age at the time of the first HIV-related code
3. At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code

Exclusion Criteria

1\. Evidence of PCV13 vaccination before the first HIV-related code
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B1851217

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT05794191

Identifier Type: REGISTRY

Identifier Source: secondary_id

B1851217

Identifier Type: -

Identifier Source: org_study_id

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