E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of RSV-associated moderate to severe lower respiratory tract illness in adults 60 years of age and older by active immunization |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of respiratory tract illness caused by a virus called Respiratory Syncytial Virus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066742 |
E.1.2 | Term | Respiratory syncytial virus infection prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Efficacy: To demonstrate the efficacy of RSVpreF in preventing RSV-associated moderate to severe lower respiratory tract illness (msLRTI-RSV) RSV in the first RSV season following vaccination. Primary Safety: To describe the safety profile of RSVpreF as measured by the percentage of participants reporting local reactions, systemic events, AEs, and SAEs. |
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E.2.2 | Secondary objectives of the trial |
Secondary Efficacy: a) To describe the efficacy of RSVpreF in preventing msLRTI-RSV across multiple RSV seasons following vaccination. b) To describe the efficacy of RSVpreF in preventing msLRTI-RSV in the second and third RSV seasons. c) To describe the efficacy of RSVpreF in preventing RSV-associated acute respiratory illness (ARI-RSV) at each RSV season and across multiple RSV seasons following vaccination. d) To describe the efficacy of RSVpreF in preventing RSV-associated severe lower respiratory tract illness (sLRTI-RSV) at each RSV season and across multiple RSV seasons following vaccination Secondary Immunogenicity: To describe the immune responses induced by RSVpreF following vaccination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 Section 10.8. 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 Section 10.1, 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 (see Section 10.3.1). •Female participants must not be of childbearing potential (see Section 10.3.3).
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy: msLRTI-RSV cases. Primary Safety: •Prompted local reactions (pain at the injection site, redness, and swelling). •Prompted systemic events (fever, nausea, diarrhea, vomiting, headache, fatigue, muscle pain, and joint pain). •AEs. •Newly diagnosed chronic medical conditions (NDCMCs) •SAEs.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Efficacy: vaccine efficacy (VE), defined as the relative risk reduction of 1st episode msLRTI-RSV cases in the RSVpreF group compared to the placebo group in the 1st RSV season (from D15) and in compliance with the key protocol criteria Safety:in participants receiving at least 1 dose of intervention -The % of participants reporting prompted local reactions within 7 days following study intervention administration in a subset of participants -The % of participants r-ing prompted systemic events within 7 days following study intervention administration in a subset of participants -The % of participants r-ing AEs through 1 month following study intervention administration -The % of participants r-ing NDCMCs throughout the study -The % of participants r-ing SAEs throughout the study
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E.5.2 | Secondary end point(s) |
Secondary Efficacy a,b) msLRTI-RSV cases c) ARI-RSV cases d) sLRTI-RSV cases Secondary Immunogenicity -RSV NT -RSVpreF-binding IgG
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary Efficacy - Timepoints described in detail in the Protocol Secondary Immunogenicity - Timepoints described in detail in the Protocol
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Japan |
South Africa |
United States |
Finland |
Netherlands |
Argentina |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject in the efficacy study (or sub-study) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 18 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 11 |