COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05596734

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com

2022-10-27

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: male or female participants 18 years of age and older 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. for participants 18 through 64 years of age: participants who have received 3 prior doses of 30 µg bnt162b2, with the last dose being 150 to 365 days before visit 1 (day 1). for participants 65 years of age and older: participants who have received 4 or 5 prior doses of a modrna sars-cov-2 vaccine, with the last dose being a bivalent vaccine, 120 days to 365 days before visit 1 (day 1). for participants 65 years of age and older: receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season 120 days or more 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. bleeding diathesis or condition associated with prolonged bleeding. women who are pregnant or breastfeeding. allergy to egg proteins (egg or egg products) or chicken proteins. 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. 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. for participants 18 through 64 years of age: vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration. 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. participation in strenuous or endurance exercise through visit 3 of the study. prior history of heart disease. any abnormal screening troponin i laboratory value. screening 12-lead ecg that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

6

BioNTech SE

18

100

United States

Healthy volunteers

N/A

180

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;Percentage of participants with abnormal troponin I laboratory values;Percentage of participants with abnormal troponin I laboratory values;Percentage of participants with new ECG abnormalities;Percentage of participants with new electrocardiogram (ECG) abnormalities

None

Phase 1

[{"arm_notes": "combination 1", "treatment_id": 2644, "treatment_name": "Bnt162b2 ba.4/ba.5+quadrivalent influenza modrna vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "combination 2", "treatment_id": 2644, "treatment_name": "Bnt162b2 ba.4/ba.5+quadrivalent influenza modrna vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "combination 3", "treatment_id": 2644, "treatment_name": "Bnt162b2 ba.4/ba.5+quadrivalent influenza modrna vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "dose 1", "treatment_id": 2643, "treatment_name": "Quadrivalent influenza modrna vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "dose 2", "treatment_id": 2643, "treatment_name": "Quadrivalent influenza modrna vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2642, "treatment_name": "Bnt162b2 ba.4/ba.5+quadrivalent inactivated influenza vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]