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NCT04977479COMPLETEDanonymous

A Randomized, Placebo-controlled Crossover Study to Assess the Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose

Sponsor

Source record

National Institute of Allergy and Infectious Diseases (NIAID)

Phase

Source record

Phase 2

Modality

AI-normalized

RNA therapy

Target

AI-normalized

mRNA-based COVID-19 vaccine (Pfizer-BioNTech), specifically assessing safety in individuals with prior systemic allergic reactions.

Indication / condition

AI-normalized

Systemic Allergic Reaction

Intervention

Source record

Pfizer-BioNTech COVID-19 Vaccine (Comirnaty), Placebo, Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Source & freshness

Source record

NCT ID

NCT04977479

Original source

ClinicalTrials.gov

Source last updated

Oct 16, 2023

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT04977479

Title

A Randomized, Placebo-controlled Crossover Study to Assess the Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

COMPLETED

Phase

Phase 2

Condition raw

Systemic Allergic Reaction

Condition normalized

Systemic Allergic Reaction

Modality raw

RNA therapy

Modality normalized

RNA therapy

Target raw

mRNA-based COVID-19 vaccine (Pfizer-BioNTech), specifically assessing safety in individuals with prior systemic allergic reactions.

Target normalized

mRNA-based COVID-19 vaccine (Pfizer-BioNTech), specifically assessing safety in individuals with prior systemic allergic reactions.

Interventions

Pfizer-BioNTech COVID-19 Vaccine (Comirnaty), Placebo, Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Public preview

Source record

The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), addresses a critical gap in the COVID-19 vaccination strategy by evaluating the safety of administering a second dose of an mRNA vaccine to individuals who previously experienced systemic allergic reactions. Given the increasing emphasis on vaccine safety and the need for inclusive vaccination strategies, this research could enhance market confidence in mRNA vaccines, potentially leading to broader acceptance and uptake. The findings may also influence regulatory guidance and public health policies, impacting competitive positioning for Pfizer-BioNTech and Moderna in the mRNA vaccine market. Companies involved in allergy treatments or vaccine development may need to consider the implications of these findings for their product pipelines and market strategies.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Randomized, Placebo-controlled Crossover Study to Assess the Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 18, 2026

NCT ID

NCT04977479

Status

COMPLETED

Phase

Phase 2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Executive brief

Investment-Ready Snapshot

The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), addresses a critical gap in the COVID-19 vaccination strategy by evaluating the safety of administering a second dose of an mRNA vaccine to individuals who previously experienced systemic allergic reactions. Given the increasing emphasis on vaccine safety and the need for inclusive vaccination strategies, this research could enhance market confidence in mRNA vaccines, potentially leading to broader acceptance and uptake. The findings may also influence regulatory guidance and public health policies, impacting competitive positioning for Pfizer-BioNTech and Moderna in the mRNA vaccine market. Companies involved in allergy treatments or vaccine development may need to consider the implications of these findings for their product pipelines and market strategies.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 16, 2023
Internal syncJun 18, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT04977479

Indication

Systemic Allergic Reaction

Modality

RNA therapy

Target

mRNA-based COVID-19 vaccine (Pfizer-BioNTech), specifically assessing safety in individuals with prior systemic allergic reactions.

Intervention

Pfizer-BioNTech COVID-19 Vaccine (Comirnaty), Placebo, Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.