NL-OMON52252
Completed
Phase 3
A phase 3 study to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus (RSV) prefusion F subunit vaccine in adults - C3671013 (9002/0849)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer
- Enrollment
- 5000
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Exclusion Criteria
- •1\. Bleeding diathesis or condition associated with prolonged bleeding that
- •would, in the opinion of the investigator, contraindicate intramuscular
- •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
Outcomes
Primary Outcomes
Not specified
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