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NCT04895982 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

A Phase 2 study, sponsored by BioNTech SE.

Completed
Registry status
Phase 2
Development phase
124
Enrollment target

NCT04895982: Completed Phase 2 study, sponsored by BioNTech SE.

NCT04895982 is a Phase 2 study that has completed, run by BioNTech SE. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04895982, a Phase 2 study, has completed, sponsored by BioNTech SE.

COMPLETED
Registry status
Phase 2
Development phase
124 participants
Enrollment target

Study Summary

This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.

Primary Outcome

GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-

Interventions

  • BIOLOGICAL BNT162b2

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2021-10-15
Est. Completion 2023-07-23
Phase Phase 2
BioNTech SE

53 total trials

What the finished NCT04895982 record still lists

NCT04895982 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which BNT162b2 is the first listed.

NCT04895982 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04895982 about?

NCT04895982 is a clinical study titled "Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years". This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, an...

What is the current status of trial NCT04895982?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2021-10-15. Estimated completion is 2023-07-23.

What interventions are being tested in trial NCT04895982?

The interventions under investigation include: BNT162b2 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04895982?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04895982's enrollment target sits among peer trials

124 564th of 2000 higher than 1,437 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04895982, the US trial registry maintained by the National Library of Medicine. NCT04895982 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.