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BNT162b2 phase 3 (C4591001, Polack), 2020 NCT04368728

Comirnaty (tozinameran - Pfizer/BIONTECH) (n=21720) vs. placebo (n=21728)

randomized controlled trial

BNT162b2
two doses, 21 days apart, of BNT162b2 vaccine candidate (30 μg per dose)

placebo

COVID-19 prophylaxis (excluding children)

Adults 16 years of age or older who were healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection. Key exclusion criteria included a medical history of Covid-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition

double-blind

152 sites worldwide

phase1/2/3 study (seamless)

C4591031- first boost, 2021 NCT04955626

Comirnaty - first boost (n=5081) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=5044)

randomized controlled trial

BNT162b2 vaccine
third dose

placebo
participants had previously received 2 doses of Comirnaty

COVID-19 prophylaxis (excluding children)

single-blind

123 sites in the United States, South Africa, and Brazil

During the interim analysis, the data monitoring committee recommended that participants be made aware of their trial-group assignments to allow those in the placebo group to receive a third vaccine dose. Data from participants who were made aware of trial-group assignments before the first interim analysis because of the regulatory decision were censored at the time of the unblinding of the trial group.

ENSEMBLE (COV3001), 0 NCT04505722

Janssen AD26 vaccine (JNJ-78436735) (n=21895) vs. placebo (n=21888)

randomized controlled trial

Janssen Ad26.COV2.S vaccine single dose (5x1010 vp) intramuscular

placebo

COVID-19 prophylaxis (excluding children)

double blind

Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States

Novavax PREVEND-19 phase 3 US (2019nCoV-301), 2021 NCT04611802

Nuvaxovid (NVX-CoV2373) Novavax (n=-9) vs. placebo (n=-9)

randomized controlled trial

NVX-CoV2373

placebo

COVID-19 prophylaxis (excluding children)

observer-blinded

119 locations in the United States and Mexico

Efficacy endpoints were accrued from January 25 through April 30, 2021, a time when the Alpha (B.1.1.7) variant became the predominant strain in the U.S

Novavax phase 2 South Africa (2019nCoV-501), 2021 NCT04533399

Nuvaxovid (NVX-CoV2373) Novavax (n=2199) vs. placebo (n=2188)

randomized controlled trial

NVX-CoV2373 2 doses
two doses, administered 21 days apart, of NVX-CoV2373 nanoparticle vaccine(5 μg recombinant spike protein with 50 μg Matrix-M1 adjuvant)

placebo

COVID-19 prophylaxis (excluding children)

B.1.351 (501Y.V2) variant was largely predominant during trial efficacy endpoint accrual

double-blind

South Africa

phase 2a/b

COVE Moderna/NIH phase 3 (study 301), 2020 NCT04470427

Spikevax (Moderna mRNA-1273 COVID-19 vaccine) (n=15181) vs. placebo (n=15170)

randomized controlled trial

mRNA-1273 vaccine
100 μg of mRNA-1273 two-dose schedule given one month apart

placebo
saline placebo two-dose schedule given one month apart

COVID-19 prophylaxis (excluding children)

double blind

100 centres, USA

Randomization was stratified based on age and the presence or absence of risk factors for severe illness for COVID-19

ChAdOx1 phase 3 (AstraZeneca), 2020 NCT04400838

Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=5807) vs. control (n=5829)

randomized controlled trial

ChAdOx1 nCoV-19 vaccine
ChAdOx1nCoV-19 group received two doses containing 5 × 10¹⁰ viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort)

meningococcal group A, C, W, and Y conjugate vaccine or saline

interval between dose 1 and dose 2 ranged from 4 to 26 weeks

COVID-19 prophylaxis (excluding children)

exclusion criteria: h history of anaphylaxis or angioedema; participants with severe and/or uncontrolled cardiovascular, gastrointestinal, liver, renal, endocrine/metabolic disease, and neurological illnesses; as well as those with immunosuppression

double blind

UK, Brazil, and South Africa.

pooled analysis of 4 studies done across the UK, Brazil, and South Africa : ISRCTN89951424(COV003), NCT04400838 (COV002), NCT04324606 (COV001), and NCT04444674 (COV005).