A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

April 30, 2024 updated by: GlaxoSmithKline

A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age

The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (>=) 60 YOA and above

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Munro Neville
        • Contact:
        • Contact:
    • Queensland
      • Tarragindi, Queensland, Australia, 4121
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ferdinandus de Looze
    • Victoria
      • North Melbourne, Victoria, Australia, 3051
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michelle Giles
      • St Albans, Victoria, Australia, 3021
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roy Rasalam
  • Canada
      • Quebec, Canada, G1N 4V3
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Francois Roussy
      • Québec, Canada, G1V 4G2
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie-Louise Vachon
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Shu
        • Contact:
        • Contact:
      • Victoria, British Columbia, Canada, V8V 4A1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael B Jones
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Murdo Ferguson
    • Ontario
      • Guelph, Ontario, Canada, N1G 0B4
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anthony Bier
      • London, Ontario, Canada, N5W 6A2
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Peter Dzongowski
        • Contact:
        • Contact:
    • Quebec
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Sebastien Gauthier
      • St-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bonavuth Pek
        • Contact:
        • Contact:
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sameer Kulkarni
      • Berlin, Germany, 10787
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Keikawus Arasteh
        • Contact:
        • Contact:
      • Berlin, Germany, 13347
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Nicole Toursarkissian
        • Contact:
        • Contact:
    • Baden-Wuerttemberg
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Beate Moeckesch
        • Contact:
        • Contact:
    • Bayern
      • Wallerfing, Bayern, Germany, 94574
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josef Grosskopf
      • Wuerzburg, Bayern, Germany, 97074
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tino F Schwarz
        • Contact:
        • Contact:
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Axel Schaefer
      • Witten, Nordrhein-Westfalen, Germany, 58455
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Horacek
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bernhard Schmitt
  • Japan
      • Ibaraki, Japan, 300-0062
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kota Yamada
      • Kanagawa, Japan, 211-0041
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masamitsu Takahashi
      • Tokyo, Japan, 155-0031
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomofumi Murakami
        • Contact:
        • Contact:
      • Tokyo, Japan, 180-0022
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Minoru Nozaki
  • South Africa
      • Bellville, South Africa, 7530
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria M Pretorius
      • Mowbray, South Africa, 7700
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan Peter
      • Newton, South Africa, 2113
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Essack Aziz Mitha
        • Contact:
        • Contact:
    • Gauteng
      • Boksburg, Gauteng, South Africa, 1459
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Agatha C Wilhase
        • Contact:
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abram Burgher
      • Tempe, Arizona, United States, 85284
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Daniel Davis
    • California
      • North Hollywood, California, United States, 91606-3287
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aaron Weinberg
      • Oakland, California, United States, 94610
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Allison Boyd
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helen L Stacey
    • Florida
      • Hialeah, Florida, United States, 33012
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Cardona
      • Miami, Florida, United States, 33173
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jorge Caso
        • Contact:
        • Contact:
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Felipe Suplicy
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark S Adams
    • Maryland
      • Silver Spring, Maryland, United States, 20904
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jonathan Cohen
        • Contact:
        • Contact:
    • New York
      • Rochester, New York, United States, 14609
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Matthew G Davis
        • Contact:
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73111
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Lunn
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Smith
    • Texas
      • DeSoto, Texas, United States, 75115
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haresh Boghara
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • James R Clark
        • Contact:
        • Contact:
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anton Grasch
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).
  • Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.

Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure.

Specific inclusion criteria for all participants in Cohort 1 • A male or female participant 18-49 YOA at the time of the study intervention administration.

  • Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:

    - Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication:

    o Chronic obstructive pulmonary disease (COPD)

    o Asthma

    o Cystic fibrosis

    o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis

    o Chronic heart failure:

    o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified)

    • Cardiac arrhythmia

      • Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
      • Other diseases at increased risk for RSV disease:
    • Chronic kidney disease
    • Chronic moderate to severe liver disease
    • Neurologic or neuromuscular conditions
  • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.

  • Female participants of childbearing potential may be enrolled in the study, if the participant:

    • has practiced adequate contraception from 1 month prior to study intervention administration, and
    • has a negative pregnancy test on the day of study prior to intervention administration, and
    • has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.

Specific inclusion criteria for all participants in Cohort 2

• A male or female participant >=60 YOA at the time of the study intervention administration.

Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator.

• Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

Exclusion Criteria:

Medical conditions

  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
  • Unstable chronic illness.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6).
  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.
  • Previous vaccination with any RSV vaccine, including investigational RSV vaccines.

  • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS).

    • Up to 3 months prior to the study intervention administration:

      • For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed
      • Administration of immunoglobulins and/or any blood products or plasma derivatives
    • Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).

Other exclusions:

Other exclusions for all participants

  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  • Bedridden participants.
  • Planned move during the study period that will prohibit participating in the study until study end.
  • Participation of any study personnel or their immediate dependents, family, or household members.

Other exclusions for Cohort 1

  • Pregnant or lactating female participant.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSV-A-AIR Group
Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
Biological: RSVPreF3 OA investigational vaccine
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1;
Experimental: RSV-OA Group
Older adults (OA) participants, >=60 YOA, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
Biological: RSVPreF3 OA investigational vaccine
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR)
Time Frame: At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated Dilution 60 (ED60).
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
Seroresponse rate (SRR) in RSV-A neutralizing titers
Time Frame: At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
SRR is defined as the proportion of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to (≥) 4. RSV-A neutralizing titers are expressed as Estimated Dilution 60 (ED60).
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR)
Time Frame: At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
RSV-B neutralizing titers are given as group GMTs and are expressed as Estimated Dilution 60 (ED60).
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
SRR in RSV-B neutralizing titers
Time Frame: At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
SRR is defined as the proportion of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as Estimated Dilution 60 (ED60).
At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants reporting solicited administration site events
Time Frame: During the 4-day follow up period after vaccination (vaccine administered at Day 1)
The assessed solicited administration site events are pain, redness and swelling at administration site.
During the 4-day follow up period after vaccination (vaccine administered at Day 1)
Percentage of participants reporting solicited systemic events
Time Frame: During the 4-day follow up period after vaccination (vaccine administered at Day 1)
The assessed solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever is defined as temperature >= 38.0 degrees Celsius (°C) /100.4 degrees Fahrenheit (°F), regardless of the location of . measurement. The route for measuring temperature can be oral or axillary.
During the 4-day follow up period after vaccination (vaccine administered at Day 1)
Percentage of participants reporting unsolicited adverse events (AEs)
Time Frame: During the 30-day follow up period after vaccination (vaccine administered at Day 1)
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.
During the 30-day follow up period after vaccination (vaccine administered at Day 1)
Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs
Time Frame: From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.
From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF)
Time Frame: From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF are considered as AESI.
From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
RSV-A neutralizing titers expressed as GMTs
Time Frame: At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration
RSV-B neutralizing titers expressed as GMTs
Time Frame: At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration
RSV-B neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Estimated)

August 12, 2024

Study Completion (Estimated)

April 25, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222253
  • 2023-510190-34-00 (Other Identifier: EU CTR Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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