Table 1.
Local and systemic reactions reported by 1917 participants in the 2005–2006 study within 7 days after receipt of study interventions.
| Intervention administered by intramuscular injection |
Intervention administered by intransal spray |
|||||||
|---|---|---|---|---|---|---|---|---|
| Reported reaction | Inactivated vaccine (n = 818) |
Placebo (n = 155) |
Difference in risk, % | P | Live attenuated vaccine (n = 787) |
Placebo (n = 157) |
Difference in risk, % | P |
| Fever | 62 (7.6) | 11 (7.1) | 0.5 | .83 | 62 (7.9) | 10 (6.4) | 1.5 | .52 |
| Chills | 55 (6.7) | 8 (5.2) | 1.5 | .47 | 45 (5.7) | 7 (4.5) | 1.2 | .53 |
| Runny nose or congestion | 201 (24.6) | 29 (18.7) | 5.9 | .12 | 336 (42.7) | 49 (31.2) | 11.5 | .008 |
| Cough | 119 (14.6) | 15 (9.7) | 4.9 | .11 | 127 (16.1) | 17 (10.8) | 5.3 | .09 |
| Sore throat | 133 (16.3) | 24 (15.5) | 0.8 | .81 | 212 (26.9) | 26 (16.6) | 10.3 | .006 |
| Headache | 225 (27.5) | 34 (21.9) | 5.6 | .15 | 261 (33.2) | 52 (33.1) | 0.1 | .99 |
| Muscle aches | 110 (13.5) | 9 (5.8) | 7.7 | .008 | 112 (14.2) | 15 (9.6) | 4.6 | .12 |
| Weakness | 180 (22.0) | 27 (17.4) | 4.6 | .20 | 181 (23.0) | 27 (17.2) | 5.8 | .11 |
| Abdominal pain | 40 (4.9) | 4 (2.6) | 2.3 | .20 | 28 (3.6) | 5 (3.2) | 0.4 | .82 |
| Trouble breathing | 23 (2.8) | 0 (0.0) | 2.8 | .018 | 20 (2.5) | 3 (1.9) | 0.6 | .22 |
| Red eyes | 20 (2.4) | 0 (0.0) | 2.4 | .030 | 15 (1.9) | 3 (1.9) | 0.0 | 1.00 |
| Arm soreness | 412 (50.4) | 22 (14.2) | 36.2 | <.001 | 33 (4.2) | 8 (5.1) | −0.9 | .61 |
| Arm redness | 58 (7.1) | 1 (0.7) | 6.4 | .002 | 5 (0.6) | 2 (1.3) | −0.7 | .23 |
| Othera | 48 (5.9) | 8 (5.2) | 0.7 | .73 | 62 (7.9) | 11 (7.0) | 0.9 | .71 |
NOTE. Data are no. (%) of participants, unless otherwise indicated. Data on reactions was obtained from 93.1% of 2058 participants; reported reactions were selected from a list of solicited reactions. The trivalent inactivated influenza vaccine used was Fluzone (Sanofi Pasteur), and the trivalent live attenuated influenza vaccine used was FluMist (MedImmune). The placebo used was physiologic saline administered as an intramuscular injection or normal allantoic fluid administered as an intranasal spray. Bold type indicates significant P values.
Other reported reactions reported by at least 5 participants included nausea (n = 34), diarrhea (n = 12), sneezing (n = 10), rash (n = 8), dizziness (n = 7), itchiness (n = 6), ear ache (n = 5). None of these reactions were significantly more likely to be reported by participants who received a vaccine, compared with those who received the matching placebo.