Table 2.
Local and Systemic Reactions to Vaccine or Placebo Occurring within 7 Days, as Reported by 1205 Participants (96.6%).*
| Reported Reaction | Inactivated Vaccine (N = 501) | Placebo (Intramuscular Injection) (N = 99) | Difference in Risk | P Value | Live Attenuated Vaccine (N = 506) | Placebo (Intranasal Spray) (N = 99) | Difference in Risk | P Value |
|---|---|---|---|---|---|---|---|---|
| no. of participants (%) | % | no. of participants (%) | % | |||||
| Fever | 37 (7.4) | 5 (5.1) | 2.3 | 0.41 | 32 (6.3) | 7 (7.1) | −0.8 | 0.78 |
| Chills | 40 (8.0) | 5 (5.1) | 2.9 | 0.31 | 27 (5.3) | 5 (5.1) | 0.2 | 0.91 |
| Runny nose or congestion | 150 (29.9) | 20 (20.2) | 9.7 | 0.05 | 247 (48.8) | 30 (30.3) | 18.5 | 0.001 |
| Cough | 80 (16.0) | 16 (16.2) | −0.2 | 0.96 | 92 (18.2) | 8 (8.1) | 10.1 | 0.01 |
| Sore throat | 93 (18.6) | 12 (12.1) | 6.5 | 0.12 | 127 (25.1) | 16 (16.2) | 8.9 | 0.06 |
| Headache | 171 (34.1) | 25 (25.3) | 8.8 | 0.09 | 192 (37.9) | 25 (25.3) | 12.6 | 0.02 |
| Muscle aches | 74 (14.8) | 13 (13.1) | 1.7 | 0.67 | 67 (13.2) | 5 (5.1) | 8.1 | 0.02 |
| Weakness | 102 (20.4) | 14 (14.1) | 6.3 | 0.15 | 117 (23.1) | 17 (17.2) | 5.9 | 0.19 |
| Abdominal pain | 28 (5.6) | 3 (3.0) | 2.6 | 0.29 | 20 (4.0) | 2 (2.0) | 2.0 | 0.56 |
| Trouble breathing | 10 (2.0) | 2 (2.0) | 0.0 | 1.00 | 17 (3.4) | 1 (1.0) | 2.4 | 0.33 |
| Red eyes | 15 (3.0) | 1 (1.0) | 2.0 | 0.49 | 10 (2.0) | 2 (2.0) | 0.0 | 1.00 |
| Arm soreness | 270 (53.9) | 20 (20.2) | 33.7 | <0.001 | 15 (3.0) | 4 (4.0) | −1.0 | 0.53 |
| Arm redness | 29 (5.8) | 2 (2.0) | 3.8 | 0.12 | 6 (1.2) | 1 (1.0) | 0.2 | 1.00 |
| Other* | 32 (6.4) | 6 (6.1) | 0.3 | 0.90 | 39 (7.7) | 6 (6.1) | 1.6 | 0.57 |
*
Other reported problems that occurred in at least 5 participants were nausea (14 participants), sneezing (8 participants), diarrhea (7 participants), dizziness (7 participants), and nosebleed (6 participants); none were significantly more likely to be reported by participants who received a vaccine as compared with those who received the matching placebo.