# Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine

> **NCT05354024** · PHASE2,PHASE3 · COMPLETED · sponsor: **Butantan Institute** · enrollment: 4400 (actual)

## Conditions studied

- Coronavirus Infections
- Healthy

## Interventions

- **BIOLOGICAL:** NDV-HXP-S 10μg
- **BIOLOGICAL:** BNT162b2 30μg

## Key facts

- **NCT ID:** NCT05354024
- **Lead sponsor:** Butantan Institute
- **Sponsor class:** OTHER_GOV
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2023-02-28
- **Primary completion:** 2023-10-05
- **Final completion:** 2024-09-25
- **Target enrollment:** 4400 (ACTUAL)
- **Last updated:** 2025-02-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05354024

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05354024, "Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine". Retrieved via AI Analytics 2026-07-02 from https://api.ai-analytics.org/clinical/NCT05354024. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*