COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05310084

Not reported

Not reported

2022-04-04

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: participants 18 through 64 years of age, inclusive, at the time of consent. are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention. have received 3 prior doses of 30 µg bnt162b2, with the third dose being at least 90 days before visit 1 (day 1). documented confirmation of prior bnt162b2 receipt must be obtained prior to randomization. capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the icd and in this protocol.

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. allergy to egg proteins (egg or egg products) or chicken proteins. history of guillain-barré syndrome. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). a positive sars-cov-2 test result (either by naat or rapid antigen test) within 28 days of visit 1 (day 1). 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. women who are pregnant or breastfeeding. vaccination with any influenza vaccine <6 months before study intervention administration, or planned receipt of any licensed or investigational nonstudy influenza vaccine during study participation. individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for copd, or planned receipt throughout the study. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. receipt of any passive antibody therapy specific to covid-19 from 90 days before study intervention administration or planned receipt throughout the study. prior receipt of any covid-19 vaccine other than bnt162b2 or receipt of more than 3 prior doses of bnt162b2. participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. investigator site staff or pfizer/biontech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

2

BioNTech SE

18

64

Australia;New Zealand

Healthy volunteers

N/A

1134

Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination;Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination;Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1;Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2;Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1;Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2;Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1;Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2;Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1;Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

None

Phase 3

[{"arm_notes": "Coadministration Group", "treatment_id": 2415, "treatment_name": "Bnt162b2+influenza vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Separate Administration Group", "treatment_id": 2415, "treatment_name": "Bnt162b2+influenza vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]