Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults. (RENOIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05035212
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of RSVpreF in the prevention of moderate to severe LRTI-RSV in adults.

Condition or disease Intervention/treatment Phase
Lower Respiratory Tract Illness Biological: RSVpreF Biological: Placebo Phase 3

Detailed Description:
This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the safety, immunogenicity, and efficacy of RSVpreF or placebo (1:1 randomization) in adults. This will be a global study that will span multiple RSV seasons.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a double-blinded, placebo-controlled study.
Primary Purpose: Prevention
Official Title: A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : June 19, 2024
Estimated Study Completion Date : June 19, 2024

Arm Intervention/treatment
Experimental: RSVpreF vaccine
RSVpreF
Biological: RSVpreF
RSV vaccine (RSVpreF)

Placebo Comparator: Placebo dose
Placebo
Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Number of first episode of RSV-associated moderate to severe lower respiratory tract illness (msLRTI-RSV) in the first RSV season [ Time Frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  2. Proportion of participants reporting prompted local reactions within 7-days after vaccination [ Time Frame: Within 7 days after vaccination ]
    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

  3. Proportion of participants reporting prompted systemic events within 7-days after vaccination [ Time Frame: Within 7 days after vaccination ]
    Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  4. Proportion of participants reporting AE within 1-month after vaccination [ Time Frame: Within 1 month after vaccination (up to 35 days) ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

  5. Proportion of participants reporting SAE throughout the study [ Time Frame: Throughout the study duration (an average of 30 months) ]
    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  6. Proportion of participants reporting NDCMC throughout the study [ Time Frame: Throughout the study duration (an average of 30 months) ]
    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).


Secondary Outcome Measures :
  1. Number of first episode of msLRTI-RSV in the second RSV season [ Time Frame: During the second RSV season (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  2. Number of first episode of msLRTI-RSV in the third RSV season [ Time Frame: During the third RSV season (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  3. Number of first episode of msLRTI-RSV through first 2 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  4. Number of first episode of msLRTI-RSV across 3 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 3 visit (an average of 18 months of surveillance) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  5. Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season [ Time Frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  6. Number of first episode of ARI-RSV in the second RSV season [ Time Frame: During the second RSV season (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  7. Number of first episode of ARI-RSV in the third RSV season [ Time Frame: During the third RSV season (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  8. Number of first episode of ARI-RSV through first 2 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  9. Number of first episode of ARI-RSV across 3 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 3 visit (an average of 18 months of surveillance) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  10. Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season [ Time Frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as msLRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to msLRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

  11. Number of first episode of sLRTI-RSV in the second RSV season [ Time Frame: During the second RSV season (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as msLRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to msLRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

  12. Number of first episode of sLRTI-RSV in the third RSV season [ Time Frame: During the third RSV season (an average of 6 months) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as msLRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to msLRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

  13. Number of first episode of sLRTI-RSV through first 2 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as msLRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to msLRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

  14. Number of first episode of sLRTI-RSV across 3 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 3 visit (an average of 18 months of surveillance) ]
    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as msLRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to msLRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

  15. Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers [ Time Frame: Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination), before season 3 (approximately 24 months after vaccination) ]
    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  16. RSV prefusion-F-binding specific antibody responses (IgG) [ Time Frame: Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination), before season 3 (approximately 24 months after vaccination) ]
    RSV prefusion-F-binding specific antibody respondee IgG, expressed as Geometric Mean Concentrations (GMCs), and GMFR. The IgG were quantified for RSV A and RSV B separately by incubating test sample sera with streptavidin-coated Luminex.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
  2. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

    Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.

  3. Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
  4. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  5. Male or female participants ≥60 years of age.

    • Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
    • Female participants must not be of childbearing potential.

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. 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.
  4. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  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.
  6. Participation in other studies involving study intervention within 28 days prior to consent and/or during study participation.
  7. Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

    Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.

  8. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
  9. Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  10. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05035212


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 239 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05035212    
Other Study ID Numbers: C3671013
2021-003693-31 ( EudraCT Number )
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Lower Respiratory Tract Illness
RSV
Vaccine