TABLE 2.

Frequencies of local and systemic solicited symptoms over the three-dose vaccination coursea

Symptom, typebNo. (%) of subjects [95% CI]
TrL3-4a (73 injected doses)eTrL3-8a (69 injected doses)TrL-8n (67 injected doses)L7-8a (71 injected doses)L7-8n (72 injected doses)VAMen (63 injected doses)
Pain
    Any54 (75) [63-85]44 (64) [51-75]48 (72) [59-82]56 (79) [68-88]46 (64) [52-75]54 (86) [75-93]
    Grade 31 (1) [0-8]1 (1) [0-8]1 (2) [0-8]4 (6) [2-14]4 (6) [2-14]13 (21) [12-33]
Redness
    Any4 (6) [2-14]2 (3) [0-10]6 (9) [3-19]3 (4) [1-12]3 (4) [1-12]8 (13) [6-24]
    >50 mm0 (0) [0-5]0 (0) [0-5]0 (0) [0-5]0 (0) [0-5]0 (0) [0-5]0 (0) [0-6]
Swelling
    Any2 (3) [0-10]3 (4) [1-12]7 (10) [4-20]7 (10) [4-19]5 (7) [2-16]12 (19) [10-31]
    >50 mm0 (0) [0-5]0 (0) [0-5]1 (2) [0-8]1 (1) [0-8]0 (0) [0-5]3 (5) [1-13]
Fatigue
    Any26 (36) [25-48]23 (33) [22-46]21 (31) [21-44]26 (37) [26-49]26 (36) [25-48]26 (41) [29-54]
    Grade 35 (7) [2-15]0 (0) [0-5]1 (2) [0-8]2 (3) [0-10]1 (1) [0-8]4 (6) [2-16]
Gastrointestinal
    Any15 (21) [12-32]7 (10) [4-20]9 (13) [6-24]16 (23) [14-34]9 (13) [6-22]12 (19) [10-31]
    Grade 31 (1) [0-7]0 (0) [0-5]0 (0) [0-5]1 (1) [0-8]0 (0) [0-5]0 (0) [0-6]
Headache
    Any28 (38) [27-51]17 (25) [15-37]22 (33) [22-45]29 (41) [29-53]23 (32) [21-44]28 (44) [32-58]
    Grade 32 (3) [0-10]0 (0) [0-5]1 (2) [0-8]1 (1) [0-8]1 (1) [0-8]3 (5) [1-13]
Feverc
    Any6 (8) [3-17]9 (13) [6-23]3 (5) [1-13]9 (13) [6-23]7 (10) [4-19]9 (14) [7-25]
    >39.5°C0 (0) [0-5]0 (0) [0-5]0 (0) [0-5]0 (0) [0-5]0 (0) [0-5]2 (3) [0-11]
Rash
    Anyd3 (4) [1-12]2 (3) [0-10]0 (0) [0-5]2 (3) [0-10]1 (1) [0-8]3 (5) [1-13]
    Grade 30 (0) [0-0]0 (0) [0-0]0 (0) [0-0]0 (0) [0-0]0 (0) [0-0]0 (0) [0-0]
  • a Symptoms were recorded during the 15-day period (days 0 to 14) following each vaccination. For study group compositions, see Table 1.

  • b Symptoms were graded on a three-level intensity scale, grade 3 symptoms being defined as those preventing normal activity, redness/swelling >50 mm diameter, and a fever of >39.5°C.

  • c Axillary temperature; fever was defined as a temperature of ≥37.5°C.

  • d No petechiae or purpura reported.

  • e n = 72 for pain, redness, and swelling in the TrL3-4a group.