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An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

NCT06534892 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10212

Last updated 2026-04-20

No results posted yet for this study

Summary

The purpose of this study is:

* To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,
* To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,
* To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSVPreF3 OA vaccine

RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Estonia
  • Finland
  • Germany
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

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 NCT06534892 on ClinicalTrials.gov