COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05630352

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com

2022-11-29

Not recruiting

nonRCT

Non-randomized

Sequential assignment

Open label

unclear

Prevention

inclusion criteria: healthy male or female participants 72 through 102 days of age, at the time of randomization (the day of birth is considered day 1 of life). male or female participants born at greater than 32 weeks of gestation.

receipt of any nonstudy vaccine within 14 days, before study intervention administration (dose 1 only). receipt of medications intended to prevent covid-19. previous or current diagnosis of mis-c (multisystem inflammatory syndrome in children). history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., 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. individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. other medical (e.g,. major known congenital malformation or serious chronic disorder such as seizures) or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. note: this includes both conditions that may increase the risk associated with study intervention administration or conditions that may interfere with the interpretation of study results. previous vaccination with any non-study coronavirus vaccine. individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab and hepatitis b immunoglobulin), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to covid-19 from 90 days before study intervention administration, or planned receipt throughout the study. receipt of other study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-pfizer interventional studies for prevention of covid-19, which are prohibited throughout study participation. 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. children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.

4

BioNTech SE

0

0

None

Healthy volunteers

N/A

120

Substudy A - Percentage of participants reporting adverse events in each dose level;Substudy A - Percentage of participants reporting local reactions in each dose level;Substudy A - Percentage of participants reporting serious adverse events in each dose level;Substudy A - Percentage of participants reporting systemic events in each dose level

None

Phase 1

[{"arm_notes": "3 microgram ", "treatment_id": 2618, "treatment_name": "Bnt162b2 ba.4/ba.5", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6 microgram ", "treatment_id": 2618, "treatment_name": "Bnt162b2 ba.4/ba.5", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10 microgram ", "treatment_id": 2618, "treatment_name": "Bnt162b2 ba.4/ba.5", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 microgram ", "treatment_id": 2618, "treatment_name": "Bnt162b2 ba.4/ba.5", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]