Table 1 Demographics and study participant characteristics, safety set

From: Original SARS-CoV-2 monovalent and Omicron BA.4/BA.5 bivalent COVID-19 mRNA vaccines: phase 2/3 trial interim results

Characteristics n (%)a

mRNA-1273.222 50 µg N = 511

mRNA-1273 50 µg N = 376

Age at screening (years)

   Mean (range)

50.8 (19–89)

57.6 (20–96)

Age subgroup

   ≥18 and <65 years

406 (79.5)

226 (60.1)

   ≥65 years

105 (20.5)

150 (39.9)

Gender

   Male

195 (38.2)

186 (49.5)

   Female

316 (61.8)

190 (50.5)

Ethnicity

   Hispanic or Latinx

58 (11.4)

37 (9.8)

   Not Hispanic or Latinx

448 (87.7)

339 (90.2)

   Not reported or unknown

5 (1.0)

0

Race

   White

426 (83.4)

322 (85.6)

   Black or African American

56 (11.0)

28 (7.4)

   Asian

11 (2.2)

16 (4.3)

   American Indian or Alaska Native

1 (0.2)

1 (0.3)

   Native Hawaiian or Other Pacific Islander

0

1 (0.3)

   Multiracial

8 (1.6)

2 (0.5)

   Other

6 (1.2)

2 (0.5)

   Not reported or unknown

3 (0.6)

4 (1.1)

Time between second injection of mRNA-1273 in the primary series and the first booster of mRNA-1273 (days)

   n

509

374

   Median

251.0

242.0

   IQR

(228–299)

(225–260)

Time between first booster dose of mRNA-1273 and the second booster (days)

   n

509

374

   Median

289.0

134.0

   IQR

(258–312)

(118–150)

Prebooster RT–PCR SARS-CoV-2

   Negative

488 (95.5)

366 (97.3)

   Positive

10 (2.0)

2 (0.5)

   Missing

13 (2.5)

8 (2.1)

Prebooster antibody to SARS-CoV-2 nucleocapsidb

   Negative

226 (44.2)

276 (73.4)

   Positive

282 (55.2)

100 (26.6)

   Missing

3 (0.6)

0

Prebooster SARS-CoV-2 statusc

   Negative

216 (42.3)

267 (71.0)

   Positive

286 (56.0)

101 (26.9)

   Positive by both RT–PCR and SARS-CoV-2 nucleocapsidb

6 (1.2)

1 (0.3)

   Positive by RT–PCR only

4 (0.8)

1 (0.3)

   Positive by SARS-CoV-2 nucleocapsid onlyb

276 (54.0)

99 (26.3)

   Missing

9 (1.8)

8 (2.1)

  1. aPercentages based on the number of participants in the safety set.
  2. bElecsys assay for binding antibody to SARS-CoV-2 nucleocapsid.
  3. cPrebooster SARS-CoV-2 status was positive if there was evidence of prior SARS-CoV-2 infection, defined as positive binding antibody against the SARS-CoV-2 nucleocapsid or positive RT–PCR at day 1; negative SARS-CoV-2 status was defined as negative binding antibody against the SARS-CoV-2 nucleocapsid and a negative RT–PCR at day 1.