COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05886777

None

None

2023-06-02

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

substudy a inclusion criteria: male or female participants ≥65 years of age at visit 1 (day 1). participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. 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. 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. participants who have received at least 3 prior us authorized mrna covid 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before visit a101 (day 1). substudy a

a confirmed diagnosis of covid 19, rsv infection, or influenza ≤120 days before study intervention administration. history of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. allergy to egg proteins (egg or egg products) or chicken proteins. any 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. receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. receipt of any rsv vaccine at any time prior to enrollment, or planned receipt throughout the study. receipt of any influenza vaccine ≤120 days before study enrollment. participation in other studies involving a study intervention within 28 days before randomization. anticipated participation in other studies within 28 days after receipt of study intervention in this study. investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

7

Pfizer

65

100

United States

Healthy volunteers

N/A

1084

Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs);Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs);Group 1 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs);Group 1 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratios (GMRs) of hemagglutination inhibition (HAI) titers.;Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs);Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers NTs;Group 2 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs);Percentage of participants reporting adverse events;Percentage of participants reporting local reactions;Percentage of participants reporting serious adverse events;Percentage of participants reporting systemic events

None

Phase 2

[{"arm_notes": "Group 2", "treatment_id": 2742, "treatment_name": "Bnt162b2+rsvpref", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Group 3", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4", "treatment_id": 2741, "treatment_name": "Rsvpref", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "Group 5", "treatment_id": 627, "treatment_name": "Quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "Group 6", "treatment_id": 2742, "treatment_name": "Bnt162b2+rsvpref", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Group 7", "treatment_id": 2743, "treatment_name": "Bnt162b2+quadrivalent inactivated influenza vaccine+rsvpref", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Group 1", "treatment_id": 2743, "treatment_name": "Bnt162b2+quadrivalent inactivated influenza vaccine+rsvpref", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]