NCT06705140 (OPAL) is a Phase 3 clinical trial of Low Dose (LD) RSVt vaccine in RSV Immunisation, sponsored by Sanofi Pasteur, a Sanofi Company.

Who is sponsoring NCT06705140?

NCT06705140 is sponsored by Sanofi Pasteur, a Sanofi Company.

What drugs are being tested in NCT06705140?

Interventions in NCT06705140: Low Dose (LD) RSVt vaccine, Standard Dose (SD) RSVt vaccine, High Dose (HD) RSVt vaccine, Placebo.

What condition does NCT06705140 study?

NCT06705140 studies RSV Immunisation.

Is NCT06705140 still recruiting?

NCT06705140 is currently terminated. Last updated 3 February 2026.

Last reviewed 2026-02-03 · How we verify

NCT06705140: OPAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Terminated Phase 3 Last updated 3 February 2026

What this trial tests

Phase 3 trial testing Low Dose (LD) RSVt vaccine in RSV Immunisation in 947 participants. Terminated before completion.

Timeline

25 November 2024

Primary endpoint
11 June 2025

11 June 2025

Quick facts

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	947
Start date	25 November 2024
Primary completion	11 June 2025
Estimated completion	11 June 2025
Sites	4 locations across Dominican Republic, Honduras

Drugs / interventions tested

Low Dose (LD) RSVt vaccine — full drug profile →
Standard Dose (SD) RSVt vaccine — full drug profile →
High Dose (HD) RSVt vaccine — full drug profile →
Placebo

Conditions studied

RSV Immunisation — all drugs for RSV Immunisation →

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 6 Months to 21 Months, any sex, with RSV Immunisation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study to be conducted in 947 healthy children enrolled at 6 months to \<22 months of age. The purpose of the study is to evaluate the non-inferiority of the immune response of the lower dose (LD) when compared to the standard dose (SD) respiratory syncytial virus infant and toddler (RSVt) vaccine and the safety of the LD, SD and high dose (HD) vaccine in preterm born children and of the HD vaccine in full term born children administered by intranasal route and compared to placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025

Verify or expand the search:

Other recruiting trials for RSV Immunisation

Currently open trials in the same condition.

NCT07203365 — RSV Immunogenicity Study in the Elderly (RISE) · Phase 3 · recruiting

Other Sanofi Pasteur, a Sanofi Company trials

Trials by the same sponsor.

NCT07536048 — A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years · not yet recruiting
NCT07222059 — Phase 3 Single Arm, Open Study on vYF in Adults · Phase 3 · completed
NCT07013747 — Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne · Phase 1, PHASE2 · recruiting
NCT06838000 — Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) i · Phase 3 · active not recruiting
NCT06793826 — Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06705140 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company
Last refreshed: 3 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06705140.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing