MedTrace Logo

Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

NCT05160766 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2025-05-20

Study results available
· View outcomes & findings →

Summary

This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2.

Part A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population.

Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.

Conditions

  • Prevention of COVID-19

Interventions

BIOLOGICAL

Comirnaty (BTN162b2)

Single booster shot (3rd dose in Part A and 4th dose in Part B)

BIOLOGICAL

Spikevax (mRNA-1273)

Single booster shot (3rd dose in Part A and 4th dose in Part B)

Sponsors & Collaborators

  • VACCELERATE

    collaborator UNKNOWN

  • European Commission

    collaborator OTHER

  • Oliver Cornely, MD

    lead OTHER

Principal Investigators

  • Oliver A Cornely, MD · University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-10-01
Completion
2023-09-13

Countries

  • Germany
  • Lithuania
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT05160766 on ClinicalTrials.gov