Table 3: Seroconversion, seroprotection (baseline and follow-up), and geometric mean titers (GMTS) (baseline and follow-up) as determined by hemagglutination inhibition assay (HAI) according to treatment group.
| Treatment Group | |||||
|---|---|---|---|---|---|
| Acetaminophen | Ibuprofen | Placebo | |||
| n/N (%) | RR (95% CI)a | n/N (%) | RR (95% Cl) a | n/N (%) | |
|
A/California/7/2009
(H1N1)pdm09 [2013–14, 2014–15, and 2015–16 seasons] |
|||||
| Seroconversion (n=117) | 35/52 (67.3%) | RR=0.86 (0.68, 1.10) |
10/15 (66.7%) | RR=0.85 (0.58, 1.26) |
39/50 (78.0%) ----- |
| Baseline Seroprotection (n=132) | 8/57 (14.0%) | RR=0.58 (0.26, 1.28) |
4/17 (23.5%) | RR=0.97 (0.37, 2.58) |
14/58 (24.1%) ----- |
| Follow-up Seroprotection (n=125) | 42/53 (79.2%) | RR=0.88 (0.75, 1.04) |
16/21 (76.2%) | RR=0.84 (0.65, 1.09) |
46/51 (90.2%) ----- |
| Baseline GMT(95%CI) (n=132) | 10.4 (7.5, 14.5) | ----- | 12.3 (6.0, 25.2) | ----- | 13.6 (10.2, 18.3) ----- |
| Follow-up GMT(95%CI) (n=125) | 80.5 (54.2, 119.5) | ----- | 109.5 (50.2, 238.6) | ----- | 105.0 (76.8, 143.5) ----- |
|
A/Texas/50/2012 (H3N2)
[2013–14 and 2014–15 seasons] |
|||||
| Seroconversion (N=85) | 22/39 (56.4%) | RR=0.93 (0.64, 1.36) |
4/8 (50.0%) | RR=0.83 (0.39, 1.73) |
23/38 (60.5%) ----- |
| Baseline Seroprotection (n=91) | 6/42 (14.3%) | RR=0.65 (0.25, 1.66) |
3/8 (37.5%) | RR=1.71 (0.59, 4.95) |
9/41 (22.0%) ----- |
| Follow-up Seroprotection (N=91) | 27/40 (67.5%) | RR=0.88 (0.67, 1.16) |
9/12 (75.0%) | RR=0.98 (0.67, 1.41) |
30/39 (76.9%) ----- |
| Baseline GMT(95%CI) (n=91) | 11.1 (7.2, 17.1) | ----- | 17.6 (3.9, 78.8) | ----- | 12.6 (8.2, 19.2) ----- |
| Follow-up GMT (95%CI)(N=91) | 61.2 (38.5, 97.2) | ----- | 82.3 (34.4, 197.2) | ----- | 79.3 (53.1, 118.5) ----- |
|
A/Switzerland/9715293/2013
(H3N2) [2015–2016 season] |
|||||
| Seroconversion (n=31) | 13/13 (100%) | RR=1 (1, 1) |
5/7 (71.4%) | RR=0.71 (0.45, 1.14) |
11/11 (100%) ----- |
| Baseline Seroprotection (n=40) | 3/15 (20.0%) | RR=1.07 (0.25, 4.49) |
4/9 (44.4%) | RR=2.37 (0.68, 8.31) |
3/16 (18.8%) ----- |
| Follow-up Seroprotection (n=33) | 13/13 (100%) | RR=1 (1, 1) |
8/9 (88.9%) | RR-0.89 (0.71, 1.12) |
11/11 (100%) ----- |
| Baseline GMT(95%CI) (n=40) | 10.0 (4.3, 23.0) | ----- | 52.4 (6.0, 455.7) | ----- | 9.0 (5.0, 16.1) ----- |
| Follow-up GMT(95%CI) (n=33) | 751.0 (377.7, 1493.2) | ----- | 665.1 (119.3, 3708.7) | ----- | 620.2 (249.5, 1541.4) ----- |
|
B/M assachusetts/2/2012
[2013–2014 and 2014–2015 seasons] |
|||||
| Seroconversion (n=85) | 17/39 (43.6%) | RR=1.38 (0.77, 2.49) |
2/8 (25.0%) | RR=0.79 (0.22, 2.87) |
12/38 (31.6%) ----- |
| Baseline Seroprotection (n=91) | 1/42 (2.4%) | RR=0.49 (0.05, 5.18) |
1/8 (12.5%) | RR=1.16 (0.70, 1.90) |
2/41 (4.9%) ----- |
| Follow-up Seroprotection (n=91) | 19/40 (47.5%) | RR=1.16 (0.70, 1.91) |
3/12 (25.0%) | RR=0.61 (0.21, 1.74) |
16/39 (41.0%) ----- |
| Baseline GMT(95%CI) (n=91) | 6.6 (5.6, 7.7) |
----- |
7.7 (3.9, 15.3) |
----- |
7.3 (5.9, 8.9) ----- |
| Follow-up GMT(95%CI) (n=91) | 20.0 (13.3, 30.1) |
----- |
12.2 (5.0, 30.2) |
----- |
19.0 (12.8, 28.2) ----- |
|
B/Brisbane/60/2008b
[20142015 and 2015–2016 seasons] |
|||||
| Seroconversion (n=74) | 5/30 (16.7%) | RR=1.21 (0.36, 4.06) |
4/15 (26.7%) | RR=1.93 (0.56, 6.67) |
4/29 (13.8%) ----- |
| Baseline Seroprotection (n=83) | 0/33 (0.0%) | RR=N/A | 0/17 (0.0%) | RR=N/A | 0/33 (0.0%) ----- |
| Follow-up Seroprotection (n=80) | 5/30 (16.7%) | RR=1.25 (0.37, 4.21) |
4/20 (20.0%) | RR=1.50 (0.42, 5.32) |
4/30 (13.3%) ----- |
| Baseline GMT(95%CI) (n=83) | 5.0 (5.0, 5.0) | ----- | 5.0 (5.0, 5.0) | ----- | 5.0 (5.0, 5.0) ----- |
| Follow-up GMT(95%CI) (N=80) | 8.4 (6.0, 11.8) | ----- | 9.3 (5.5, 15.9) | ----- | 7.9 (5.5, 11.5) ----- |
|
B/Phuket/3073/2013 [2015- 2016 season] |
|||||
| Seroconversion (n=31) | 2/13 (15.4%) | RR=1.69 (0.18, 16.26) |
2/7 (28.6%) | RR=3.14 (0.35, 28.52) |
1/11 (9.1%) ----- |
| Baseline Seroprotection (n=40) | 0/15 (0.0%) | RR=N/A | 0/9 (0.0%) | RR=N/A | 0/16 (0.0%) ----- |
| Follow-up Seroprotection (n=33) | 2/13 (15.4%) | RR=1.69 (0.18, 16.25) |
3/9 (33.3%) | RR=3.67 (0.46, 29.49) |
1/11 (9.1%) ----- |
| Baseline GMT(95%CI) (n=40) | 5.0 (5.0, 5.0) | ----- | 5.0 (5.0, 5.0) | ----- | 5.0 (5.0, 5.0) ----- |
| Follow-up GMT(95%CI) (n=33) | 8.5 (4.4, 16.6) | ----- | 14.1 (4.2, 47.2) | ----- | 10.0 (5.8, 17.3) ----- |
a
Relative Risk (RR) and 95% CI for seroconversion and seroprotection was determined comparing each treatment group individually versus placebo
b
Quadrivalent IIV only