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RESPIRATORY SYNCYTIAL VIRUS (RSV)Phase 3MONETNCT05842967

A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease

A Phase 3 study testing RSVpreF in people with RESPIRATORY SYNCYTIAL VIRUS (RSV), run by Pfizer at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to learn about the safety and immunogenicity of a study vaccine (called RSVpreF) in several adult groups. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
RESPIRATORY SYNCYTIAL VIRUS (RSV)
What is being tested?
RSVpreF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
885 participants
Where
36 sitesUnited States
Study dates
11 May 2023to 18 Mar 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Substudy A Inclusion Criteria:

  1. Capable of giving signed informed consent as described per protocol.
  2. Participants ≥18 to <60 years of age at study enrollment.
  3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment.
  4. Participants who are willing and able to comply with all scheduled visits, vaccination plan, lifestyle considerations, and other study procedures.
  5. Participants who are considered at high risk of RSV disease by virtue of the following:
  • Adults with chronic pulmonary (including asthma), cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus).

Chronic medical conditions for this substudy are defined as:

  • Duration greater than 6 months.
  • Stable disease not requiring a significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention.
  • Requires regular medical follow-up or ongoing medication or hospitalization in the previous year.
  • Additional groups at high risk include:
  • Residents of nursing homes and other long-term care facilities.

Substudy A Exclusion Criteria:

  1. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  3. Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
  4. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: Specific criteria for participants with known stable infection with HIV can be found in protocol.
  7. Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids*, eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration or planned receipt throughout the study. *Applies to systemic corticosteroids administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune disease). Systemic corticosteroids administered at a dose of <20 mg/day of prednisone or equivalent are permitted. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
  8. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration or planned receipt of these medications prior to the final blood draw. Note: Monoclonal antibodies with targeted mechanisms of action used in the management of chronic illnesses (eg, migraine headaches, osteoporosis) are permitted, provided they do not meet exclusion criterion 7.
  9. Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  10. Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-month follow-up visit.
  11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Substudy B Inclusion Criteria

  1. Capable of giving signed informed consent as described per protocol.
  2. Participants ≥18 years of age at study enrollment.
  3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment.
  4. Participants who are willing and able to comply with all scheduled visits, vaccination plan, lifestyle considerations, and other study procedures.
  5. Participants who are immunocompromised by virtue of the following: •Having known advanced NSCLC with at least 1 of the following:
  • Has received initial or maintenance chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment-naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration of initial vaccination or second vaccination; and/or
  • Is receiving checkpoint inhibitor treatment (PD-1/PD-L1 inhibitor, CTLA-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment; or
  • Is receiving targeted drug therapy (EGFR, ALK, ROS1, BRAF, RET, MET, NTRK inhibitors) and has undergone at least 1 treatment cycle prior to enrollment. OR - Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease . OR - Is on active immunomodulator therapy (eg, TNFα inhibitor, tofacitinib, or MTX) for an autoimmune inflammatory disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, or inflammatory bowel disease, such as ulcerative colitis or Crohn's disease) at a stable*dose. *Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to enrollment. See protocol for details on stable dose for MTX. OR - Is receiving an SOT (kidney, liver, lung, or heart) at least 3 months (84 days) prior to enrollment (Visit 201) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 201). Substudy B Exclusion Criteria:

1.Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

2.History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.

3.Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment.

4.Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.

5.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Note: Specific criteria for participants with known stable infection with HIV can be found in protocol.

6.Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration.

7.Receipt of blood/plasma products or immunoglobulin (IVIG, SCIG) within 60 days before study intervention administration or planned receipt of these medications prior to the final blood draw.

Note: Please see the inclusion criteria in the protocol regarding criteria for targeted immunoglobulin therapies for underlying medical conditions.

Note: Monoclonal antibodies with targeted mechanisms of action used in the management of chronic illnesses (eg, migraine headaches, osteoporosis) are permitted.

8.Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.

9.Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-month follow-up visit.

10.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • North Alabama Research Center

    Athens, Alabama, 35611

  • Orion Clinical Research

    Austin, Texas, 78759

  • Institute of Human Virology (IHV)

    Baltimore, Maryland, 21201

  • Central Research Associates

    Birmingham, Alabama, 35205

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • New England Research Associates, LLC

    Bridgeport, Connecticut, 06606

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • University of Iowa

    Iowa City, Iowa, 52242

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • Orange County Research Center

    Lake Forest, California, 92630

  • Kaiser Permanente

    Los Angeles, California, 90027

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Clinical Neuroscience Solutions - Orlando - South Delaney Avenue

    Orlando, Florida, 32806

  • Hope Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • AIM Trials, LLC

    Plano, Texas, 75093

  • Epic Medical Research

    Red Oak, Texas, 75154

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO

    Springfield, Missouri, 65802

  • Bio-Kinetic Clinical Applications LLC dba QPS-MO (Patient Screening Only)

    Springfield, Missouri, 65807

  • Hope Research Institute

    Tempe, Arizona, 85284

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • GW Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • GW Vaccine Research Unit

    Washington D.C., District of Columbia, 20037

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A PHASE 3 PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE

The purpose of this study is to learn about the safety and immunogenicity of a study vaccine (called RSVpreF) in several adult groups. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Vaccines help your body make antibodies which help fight against diseases. This is called an immune response. This study will measure how much antibody participants make after receiving RSVpreF (immunogenicity).

The study consists of 2 groups (Substudy A and Substudy B).

Read more

Substudy A is seeking approximately 675 participants who are:

  • Between 18 and 60 years of age.
  • Considered having a high likelihood of severe RSV disease due to certain long-term medical conditions. Such medical conditions do not include immunocompromising conditions.

Participants will need to come to the study clinic at least 2 times. At the first clinic visit, participants will receive 1 shot of RSVpreF or placebo in the arm by chance. A placebo looks like the study vaccine but contains no active ingredients. At each clinic visit, a blood sample will be taken. A third (final) visit can be either completed in clinic or via telephone contact. This study is about 6 months long for each participant.

Substudy B is seeking approximately 200 participants who are:

  • At least 18 years of age. About half of the participants will be at least 60 years of age.
  • Considered having a weakened immune system (immunocompromised). Participants will need to come to the study clinic at least 3 times. All participants will receive a shot of RSVpreF at the first study clinic visit. The second study clinic visit will be 1 month later. All participants will receive a second shot of the study vaccine at this second study clinic visit. Blood samples will be taken at the 3 study clinic visits. A fourth (final) visit can be either completed in clinic or via telephone contact. This study is about 7 months long for each participant.
Read the detailed description

This is a Phase 3 protocol that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults at high risk of severe RSV disease. Each substudy design is detailed separately, and these substudies may be conducted in parallel, as required by the clinical plan, within the framework of this protocol.

Substudy A Design:

This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults 18 to <60 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions.

Approximately 675 participants ≥18 to <60 years of age considered at high risk of RSV disease due to certain chronic medical conditions, excluding immunocompromising conditions, will be randomized to receive a single 120-µg dose of RSVpreF or placebo in a 2:1 ratio. Enrollment will be monitored to help ensure distribution of vaccination across the age range. The duration of study participation for each participant will be 6 months, with 3 scheduled visits.

All participants will have blood drawn at baseline prior to vaccination and at 1 month after vaccination to assess immunogenicity. Immunogenicity elicited at 1 month after vaccination with RSVpreF in Substudy A will be bridged to the immunogenicity of participants 60 years of age and older in the C3671013 study, in which RSVpreF efficacy was demonstrated.

Local reaction and systemic event data will be collected in an e-diary for 7 days after study vaccination (Days 1 through 7, where Day 1 is the day of vaccination). Reported Grade 3 reactogenicity will be assessed by the study site to determine if an unscheduled visit is required.

For all participants, AEs will be collected from informed consent through 1 month following study intervention administration, and AESIs, NDCMCs and SAEs will be collected from informed consent throughout study participation. In addition, AEs occurring up to 48 hours after blood draws that are related to study procedures will be collected.

Substudy B Design:

This is a Phase 3, single-arm, open-label, multicenter study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in immunocompromised adults.

Substudy B included approximately 200 immunocompromised adults ≥18 years of age, that will receive 2 120-µg doses of RSVpreF with an interval of 1 month. Approximately 100 participants will be ≥60 years of age and approximately 100 participants will be ≥18 to 60 years of age. Enrollment will be monitored to help ensure distribution of vaccination across the age ranges and underlying immunocompromising conditions. The duration of study participation for each participant will be 7 months, with 4 scheduled visits. All participants will have blood drawn at baseline prior to vaccination and at 1 month after (each) vaccination to assess immunogenicity.

Local reaction and systemic event data will be collected in an e-diary for 7 days after study vaccination (Days 1 through 7, where Day 1 is the day of vaccination). Reported Grade 3 reactogenicity will be assessed by the study site to determine if an unscheduled visit is required.

For all participants, AEs will be collected from informed consent through 1 month following the last study intervention administration, and AESIs, NDCMCs and SAEs will be collected from informed consent throughout study participation. In addition, AEs occurring up to 48 hours after blood draws that are related to study procedures will be collected.

Being tested
RSVpreF, Placebo
Keywords
RESPIRATORY SYNCYTIAL VIRUS (RSV), ADULTS AT HIGH RISK, IMMUNOCOMPROMISED ADULTS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVpreFBiological

    120-µg

  • PlaceboOther

    Placebo

Study groups in NCT05842967
Study groupRoleWhat they receive
Substudy A - RSVpreFExperimentalParticipants will receive a single 120-µg dose of RSVpreF at Visit 1
Receives: Biological: RSVpreF
Substudy A - PlaceboPlacebo comparatorParticipants will receive placebo at Visit 1
Receives: Other: Placebo
Substudy B - RSVpreFExperimentalParticipants will receive 120-µg doses of RSVpreF at Visit 1 and Visit 2 (open label, single arm only)
Receives: Biological: RSVpreF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination

    Local reactions included pain at injection site, redness and swelling, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: >2.5 cm to 5.0 cm; moderate: >5.0 cm to 10.0 cm; severe: >10 cm.

    Measured: Within 7 Days after Vaccination (Vaccination on Day 1)

  2. SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination

    Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 degrees Celsius (deg C) and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C and severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: >2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.

    Measured: Within 7 Days after Vaccination (Vaccination on Day 1)

  3. SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. AEs included both serious and all non-serious adverse events.

    Measured: Within 1 Month after Vaccination (Vaccination on Day 1)

  4. SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Throughout the Study

    A NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions.

    Measured: Within 6 Months after Vaccination (Vaccination on Day 1)

  5. SSA: Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.

    Measured: Within 6 Months after Vaccination (Vaccination on Day 1)

  6. SSA: Geometric Mean Ratio (GMR) Estimated by Ratio of the Geometric Mean Titers (GMTs) at 1 Month After Vaccination in Study C3671023 Participants Compared to Study C3671013 Adults >= 60 Years

    In this outcome measure, GMTs for RSV A and RSV B neutralizing titers (NTs) are reported. In statistical section, GMT ratio estimated by the ratio of the GMTs for RSV A and RSV B serum NTs at 1 month after vaccination with RSVpreF in current study C3671023 participants to that in study C3671013 adults >=60 years of age, is reported. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student t distribution).

    Measured: At 1 Month after Vaccination (Vaccination on Day 1)

  7. SSA: Percentage of Participants With Seroresponse Rate and Difference in Seroresponse Rates of RSV A and RSV B Serum NTs at 1 Month After Vaccination for Participants in Study C3671023 and C3671013 Adults >= 60 Years

    Seroresponse was defined as achieving a >=4-fold rise from baseline (before vaccination), if the baseline measurement was above the lower limit of quantitation (LLOQ). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4* LLOQ was considered a seroresponse.

    Measured: At 1 Month after Vaccination (Vaccination on Day 1)

  8. SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

    Local reactions included pain at injection site, redness and swelling, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: > 2.0 cm to 5.0 cm; moderate: > 5.0 cm to 10.0 cm and severe: > 10 cm.

    Measured: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1)

  9. SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

    Local reactions included pain at injection site, redness and swelling, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit = 0.5 cm. Redness and swelling were graded as mild: >2.0 cm to 5.0 cm; moderate: >5.0 cm to 10.0 cm and severe: >10 cm.

    Measured: Within 7 Days after Vaccination 2 (Vaccination 2: 1-month post-vaccination 1 on Day 1)

  10. SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

    Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 degrees Celsius (deg C) and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C and severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: >2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.

    Measured: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1)

  11. SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

    Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 degrees Celsius (deg C) and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C and severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: >2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.

    Measured: Within 7 Days after Vaccination 2 (Vaccination 2: 1-month post-vaccination 1 on Day 1)

  12. SSB: Percentage of Participants With AEs From Vaccination 1 Through 1 Month After Vaccination 2

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. AEs included both serious and all non-serious adverse events.

    Measured: From Vaccination 1 (on Day 1) through 1 month after Vaccination 2 (1 month after Vaccination 1) [approximately up to maximum of 2 months]

  13. SSB: Percentage of Participants With NDCMCs From Vaccination Throughout the Study

    A NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions.

    Measured: From Vaccination 1 (on Day 1) through 6 months after Vaccination 2 (1 month after Vaccination 1) [approximately up to maximum of 7 months]

  14. SSB: Percentage of Participants With SAEs Throughout the Study

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.

    Measured: From Vaccination 1 (on Day 1) through 6 months after Vaccination 2 (1 month after Vaccination 1) [approximately up to maximum of 7 months]

  15. SSB: GMT of NT for RSV A and RSV B Before Vaccination 1

    GMT of RSV A and RSV B before vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

    Measured: Before Vaccination 1 (on Day 1)

  16. SSB: GMT of NT for RSV A and RSV B 1 Month After Vaccination 1

    GMT of RSV A and RSV B before vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

    Measured: 1 Month After Vaccination 1 (on Day 1)

  17. SSB: GMT of NT for RSV A and RSV B 1 Month After Vaccination 2

    GMT of RSV A and RSV B before vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

    Measured: 1 Month After Vaccination 2 (1-month post Vaccination 1)

Secondary outcomes (4)

  1. SSB: Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Vaccination 1 to 1 Month Post-Vaccination 1

    GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

    Measured: At 1 Month After Vaccination 1 (on Day 1) to 1 Month Post-Vaccination 1

  2. SSB: GMFR of NTs for RSV A and RSV B From Vaccination 1 to 1 Month Post-Vaccination 2

    GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

    Measured: At 1 Month After Vaccination 1 (on Day 1) to 1 Month Post-Vaccination 2

  3. SSA: GMT of NTs for RSV A and RSV B Before Vaccination and 1 Month After Vaccination

    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

    Measured: SSA: Before Vaccination (on Day 1) and 1 Month After Vaccination

  4. SSA: GMFR of NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination

    GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

    Measured: SSA: Before Vaccination (on Day 1) and 1 Month After Vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start11 May 2023
  3. Primary completion18 Mar 2024
  4. Study completion18 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Substudy A: Phase 3, multicenter, randomized, double-blinded, placebo-controlled study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults 18 to \<60 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions. Approximately 675 participants ≥18 to \<60 years of age considered at high risk of RSV disease due to certain chronic medical conditions, excluding immunocompromising conditions, will be randomized to receive a single 120-µg dose of RSVpreF or placebo in a 2:1 ratio. Substudy B: Phase 3, single-arm, open-label, multicenter study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in immunocompromised adults. Approximately 200 immunocompromised adults ≥18 years of age will receive 2 120-µg doses of RSVpreF with an interval of 1 month. Approximately 100 participants will be ≥60 years of age and approximately 100 participants will be ≥18 to 60 years of age.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
885 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842967
Sponsor's protocol ID
C3671023
Other IDs
NCT05842967
Acronym
MONET
Status last verified
Jul 2025
First submitted
24 Apr 2023
Last updated
8 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Almeida NC, Parameswaran L, DeHaan EN, Wyper H, Rahman F, Jiang Q, Li W, Patton M, Lino MM, Majid-Mahomed Z, Malkin E, Davis M, Towner WJ, Saharia K, Ilangovan K, Kalinina E, Cooper D, Swanson KA, Anderson AS, Gurtman A, Munjal I. Immunogenicity and Safety of the Bivalent Respiratory Syncytial Virus Prefusion F Subunit Vaccine in Immunocompromised or Renally Impaired Adults. Vaccines (Basel). 2025 Mar 19;13(3):328. doi: 10.3390/vaccines13030328.

    PubMed 40266222

  • Davis M, Towner W, DeHaan E, Jiang Q, Li W, Rahman F, Patton M, Wyper H, Lino MM, Sarwar UN, Majid-Mahomed Z, Mehta S, Howitt W, Cannon K, Kalinina E, Cooper D, Swanson KA, Anderson AS, Gurtman A, Munjal I; MONeT Study Team. Bivalent RSVpreF Vaccine in Adults 18 to <60 Years Old With High-Risk Conditions. Clin Infect Dis. 2025 Apr 30;80(4):911-920. doi: 10.1093/cid/ciae550.

    PubMed 39523547

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVpreF in people with RESPIRATORY SYNCYTIAL VIRUS (RSV), run by Pfizer at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination (time frame: Within 7 Days after Vaccination (Vaccination on Day 1)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05842967, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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