Table 5.
Multiple stepwise cumulative odds logistic regression analysis of the adverse reaction severity.
| All participants |
Vaccine |
Placebo |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Variable | b' | OR | Variable | b' | OR | Variable | b' | OR | |
| AR D28 | Num | −0.04 | 0.86 (0.75,0.98) | Throat | −0.05 | 0.68(0.48,0.98) | Num | −0.08 | 0.75 (0.61,0.92) |
| BMI | 0.04 | 1.19 (1.03,1.37) | BMI | 0.06 | 1.26 (1.01,1.57) | ||||
| Solicited AR D7 | BMI | 0.04 | 1.19 (1.03,1.38) | – | – | – | Num | −0.06 | 0.79 (0.65,0.97) |
| BMI | 0.05 | 1.25 (1.00,1.56) | |||||||
| Systemic AR D7 | BMI | 0.04 | 1.17 (1.01,1.35) | – | – | – | – | – | – |
| Fever | – | – | – | – | – | – | – | – | – |
| Diarrhea | Num | −0.13 | 0.58 (0.37,0.92) | – | – | – | Num | −0.19 | 0.46 (0.26,0.85) |
| ANV | Num | −0.09 | 0.68 (0.47,0.98) | – | – | – | BMI | 0.14 | 1.74 (1.01,3.01) |
| IDF | – | – | – | Age | 0.19 | 3.21 (1.18,8.74) | – | – | – |
| Allergy | – | – | – | – | – | – | – | – | – |
| Local AR D7 | Group | −0.29 | 0.31 (0.17,0.56) | – | – | – | – | – | – |
| Pain | Group | −0.36 | 0.23 (0.10,0.57) | – | – | – | BMI | 0.37 | 5.73 (1.02,32.10) |
| Redness | Group | −0.57 | 0.07 (0.01,0.57) | – | – | – | – | – | – |
| Pruritus | – | – | – | – | – | – | – | – | – |
| Swelling | Group | −0.47 | 0.11 (0.01,0.84) | BMI | 0.28 | 3.06 (1.28,7.32) | – | – | – |
| BMI | 0.26 | 2.84 (1.21,6.66) | |||||||
| Indurations | – | – | – | – | – | – | – | – | – |
| Unsolicited AR D28 | Num | −0.35 | 0.27 (0.14,0.51) | Age | −0.32 | 0.27 (0.11,0.65) | Num | −0.60 | 0.11 (0.04,0.32) |
| Age | −0.28 | 0.32 (0.16,0.64) | Throat | −0.33 | 0.27 (0.11,0.66) | ||||
| Cold/RTI | Num | −0.36 | 0.27 (0.14,0.51) | Age | −0.31 | 0.30 (0.11,0.68) | Num | −0.60 | 0.11 (0.04,0.33) |
| Age | −0.28 | 0.32 (0.16,0.64) | Throat | −0.33 | 0.27 (0.11,0.67) | ||||
Dependent variable was the severity of each adverse reaction (mild, moderate, and severe), and independent variables included group (vaccine or placebo) (only for all participants), different safety analysis population (after initial injection or booster injection) (Num), age strata (6–35 or 36–71 months), BMI (<18.5 or >18.5 kg/m2), gender (male or female), and throat status (whether or not the participant experienced throat discomfort before injection). b ' : standard estimate of parameter. OR: Odds ratio.