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A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

NCT04652102 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 39680

Last updated 2024-04-29

Study results available
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Summary

The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.

Conditions

Interventions

BIOLOGICAL

CVnCoV

Intramuscular (IM) injection.

BIOLOGICAL

Placebo

Intramuscular (IM) injection.

BIOLOGICAL

Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program

Intramuscular (IM) injection will be received as standard of care (SoC) outside the study.

Sponsors & Collaborators

  • CureVac

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2022-06-10
Completion
2022-06-10

Countries

  • Argentina
  • Belgium
  • Colombia
  • Dominican Republic
  • Germany
  • Mexico
  • Netherlands
  • Panama
  • Peru
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652102 on ClinicalTrials.gov