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

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ClinicalTrials.gov Identifier: NCT05035212
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 20, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date January 14, 2022
Actual Study Start Date  ICMJE August 31, 2021
Estimated Primary Completion Date June 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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 responsee 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
Official Title  ICMJE A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Lower Respiratory Tract Illness
Intervention  ICMJE
  • Biological: RSVpreF
    RSV vaccine (RSVpreF)
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: RSVpreF vaccine
    RSVpreF
    Intervention: Biological: RSVpreF
  • Placebo Comparator: Placebo dose
    Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)
30000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2024
Estimated Primary Completion Date June 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3).

    Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 12 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Canada,   Finland,   Japan,   Netherlands,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05035212
Other Study ID Numbers  ICMJE C3671013
2021-003693-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP