CD2H COVID-19

A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

Purpose

The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.

Conditions

Influenza
COVID-19 (Coronavirus Disease 2019)

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Participants 18 years of age or older - Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study

Exclusion Criteria

Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment - Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment. - Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1. Refer to the study contact for further eligibility details

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A	Low Dose COVID-19 Vaccine (1a)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm B	Low Dose COVID-19 Vaccine ( 1b)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm C	Low Dose COVID-19 Vaccine ( 1c)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm D	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm E	Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm F	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm G	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator Arm H	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm I	Licensed Influenza Vaccine (1)	Biological: Licensed Influenza Vaccine 1 Licensed Influenza Vaccine 1
Experimental Arm J	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm K	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm L	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator Arm M	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm N	Licensed Influenza Vaccine (2)	Biological: Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2
Experimental Arm AA	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm BB	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm CC	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm DD	Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm EE	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator Arm FF	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm GG	Licensed Influenza Vaccine (3)	Biological: Licensed Influenza Vaccine 3 Licensed Influenza Vaccine 3
Active Comparator Arm HH	Licensed Influenza Vaccine (2)	Biological: Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2
Experimental Arm II	Low Dose COVID-19 Vaccine ( 1b)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm JJ	Low Dose COVID-19 Vaccine ( 1c)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm KK	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm LL	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm MM	Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm NN	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm OO	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm PP	Medium Dose Investigational Influenza Vaccine (1)	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine
Experimental Arm QQ	High Dose Investigational Influenza Vaccine (2)	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine
Active Comparator Arm RR	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm SS	Licensed Influenza Vaccine (3)	Biological: Licensed Influenza Vaccine 3 Licensed Influenza Vaccine 3

Recruiting Locations

More Details

NCT ID: NCT06821061
Status: Active, not recruiting
Sponsor: BioNTech SE

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.