The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 virus particle (vp) dose level, administered >= 6 months after single-dose primary vaccination with Ad26.COV2.S (5*10^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered >=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, administered >= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.
Biological: Ad26.COV2.S
Participants will receive IM injection of Ad26.COV2.S.
Other Name: Array
Inclusion Criteria:
- Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between
the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=)
6 months prior to study vaccination on VAC31518COV2008, however a window of maximum
-20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose
regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months
prior to study vaccination on COV2008, however a window of a maximum of -20 days is
allowed
- Participant must provide consent indicating that he or she understands the purpose,
procedures and potential risks and benefits of the study, and is willing to
participate in the study
- Participant agrees to not donate bone marrow, blood, and blood products from the study
vaccine administration until 3 months after receiving the study vaccine
- Participant must be willing to provide verifiable identification, has means to be
contacted and to contact the investigator during the study
- Participant must be able to read, understand, and complete questionnaires in the
electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease
(COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic
patient-reported outcomes (ePROs). Participants with visual impairment are eligible
for study participation and may have caregiver assistance in completing the eCOA
questionnaires
Exclusion Criteria:
- Participant has a clinically significant acute illness (this does not include minor
illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
>= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the
planned study vaccination; randomization at a later date is permitted at the
discretion of the investigator. Please notify the sponsor (or medical monitor) of this
decision
- Participant has a known or suspected allergy or history of anaphylaxis or other
serious adverse reactions to vaccines or their excipients (including specifically the
excipients of the study vaccine
- Participant received treatment with immunoglobulins (Ig) in the 3 months or exogenous
blood products (autologous blood transfusions are not exclusionary) in the 4 months
before the planned administration of the study vaccine or has any plans to receive
such treatment during the study
- Participant has a known history of confirmed severe acute respiratory syndrome
coronavirus-2 (SARS-CoV-2) infection
- Participant has a history of heparin-induced thrombocytopenia or thrombosis in
combination with thrombocytopenia
- Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
- History of capillary leak syndrome
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Synexus Clinical Research US, Inc
Tucson, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Ark Clinical Research
Long Beach, California, United States
Velocity Clinical Research
North Hollywood, California, United States
Velocity Clinical Research, Hallandale Beach
Hallandale Beach, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Synexus Clinical Research US, Inc
Orlando, Florida, United States
Synexus Clinical Research US, Inc
The Villages, Florida, United States
Optimal Research
Peoria, Illinois, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, United States
Accellacare US Inc
Mount Pleasant, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Crofoot Research Center
Houston, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Janssen Vaccines & Prevention B.V. Clinical Trial, Study Director
Janssen Vaccines & Prevention B.V.