A phase 3 study to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus (RSV) prefusion F subunit vaccine in adults

Phase 3

Completed

• Conditions: Respiratory Syncytial Virus (RSV); Virus disease; 10047438

• Registration Number: NL-OMON52252
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5000

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).

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 through and including the 6-month 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified