Background
Methods
Study area
Study design and participants
Data management and analysis
Ethical aspects
Results
Infants
Reported side effects | Week 1 | Week 2–4 | Week 1–18 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Frequencya
| RR (95 % CI)a
| P-valuea
| Duration of symptom (Days) | P-valuec
| Frequency | RR (95 % CI) | P- value | Duration of symptom (Days) | P-value | Frequency | RR (95 % CI) | P-value | Duration of symptom (Days) | P-value | |||||||
A | B | A | B | A | B | A | B | A | B | A | B | ||||||||||
Rhinitis | 10 | 9 | 1.14 (0.37–3.60) | 1.00 | 41 | 40 | 0.87 | 16 | 13 | 1.36 (0.51–3.64) | 0.65 | 151 | 98 | 0.53 | 20 | 19 | 1.09 (0.44–2.74) | 1.00 | 223 | 185 | 0.86 |
Cough | 5 | 6 | 0.81 (0.18–3.50) | 1.00 | 7 | 19 | 0.11 | 14 | 8 | 2.09 (0.70–6.51) | 0.22 | 118 | 51 | 0.79 | 23 | 21 | 1.19 (0.48–2.96) | 0.83 | 167 | 103 | 0.54 |
Skin eruption | 3 | 5 | 0.57 (0.08–3.18) | 0.71 | 16 | 20 | 0.47 | 6 | 6 | 1.00 (0.24–4.10) | 1.00 | 29 | 31 | 0.94 | 10 | 7 | 1.55 (0.47–5.34) | 0.59 | 38 | 56 | 0.26 |
Diarrhea | 3 | 0 | ∞ | 0.24 | 3 | 0 | – | 6 | 6 | 1.00 (0.24–4.10) | 1.00 | 7 | 12 | 0.42 | 9 | 8 | 1.16 (0.35–3.86) | 1.00 | 12 | 15 | 0.24 |
Conjunctivits | 1 | 7 | 0.12 (0.002–1.05) | 0.06 | 2 | 22 | 0.40 | 6 | 1 | 6.77 (0.76–318.28) | 0.11 | 19 | 4 | 0.80 | 9 | 9 | 1.00 (0.31–3.23) | 1.00 | 18 | 26 | 0.18 |
Vomiting | 2 | 6 | 0.30 (0.03–1.84) | 0.27 | 2 | 14 | 0.25 | 5 | 2 | 2.68 (0.41–29.42) | 0.43 | 15 | 3 | 0.37 | 7 | 7 | 1.00 (0.27–3.70) | 1.00 | 18 | 17 | 1.00 |
Anal fissure | 1 | 0 | ∞ | 1.00 | 1 | 0 | – | 1 | 0 | ∞ | 1.00 | 2 | 0 | – | 4 | 1 | 4.29 (0.40–216.11) | 0.36 | 19 | 1 | 0.50 |
Others | 2 | 3 | 0.65 (0.05–6.01) | 1.00 | 4 | 15 | 0.44 | 2 | 3 | 0.65 (0.05–6.03) | 1.00 | 5 | 16 | 0.44 | 14 | 16 | 0.82 (0.31–2.15) | 0.82 | 28 | 32 | 0.52 |
Mothers
Reported side effects | Week 1 | Week 2–4 | Week 1–18 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Frequencya
| RR (95 % CI)b
| P-valueb
| Duration of symptom (Days) | P-valuec
| Frequency | RR (95 % CI) | P-value | Duration of symptom (Days) | P-value | Frequency | RR (95 % CI) | P-value | Duration of symptom (Days) | P-value | |||||||
A | B | A | B | A | B | A | B | A | B | ||||||||||||
Headache/diziness | 11 | 2 | 6.96 (1.35–67.43) | 0.01 | 27 | 5 | 0.55 | 7 | 5 | 1.48 (0.37–6.40) | 0.76 | 44 | 13 | 0.22 | 15 | 9 | 2.00 (0.70–5.94) | 0.23 | 79 | 22 | 0.43 |
Rhinitis | 5 | 3 | 1.75 (0.31–11.94) | 0.71 | 10 | 14 | 0.39 | 5 | 7 | 0.67 (0.16–2.74) | 0.76 | 103 | 143 | 0.94 | 12 | 7 | 1.97 (0.62–6.61) | 0.30 | 71 | 49 | 0.68 |
Skin Eruption | 4 | 2 | 2.09 (0.28–24.17) | 0.68 | 19 | 7 | 0.51 | 6 | 2 | 3.31 (0.54–34.94) | 0.27 | 43 | 2 | 0.11 | 7 | 3 | 2.58 (0.54–16.38) | 0.31 | 77 | 10 | 0.15 |
Pruritus | 2 | 2 | 1.00 (0.07–14.38) | 1.00 | 7 | 7 | 1.00 | 2 | 0 | ∞ | 0.49 | 12 | 0 | – | 4 | 2 | 2.09 (0.28–24.17) | 0.68 | 24 | 8 | 0.52 |
Parestheia | 2 | 2 | 1.00 (0.07–14.38) | 1.00 | 3 | 2 | 1.00 | 2 | 0 | ∞ | 0.49 | 12 | 0 | – | 2 | 3 | 0.65 (0.05–6.01) | 1.00 | 15 | 3 | 0.22 |
Cough | 1 | 0 | ∞ | 1.00 | 1 | 0 | – | 5 | 1 | 5.50 (0.57–265.92) | 0.20 | 30 | 5 | 1.00 | 6 | 2 | 3.31 (0.54–34.94) | 0.27 | 37 | 6 | 0.75 |
Conjunctivits | 2 | 0 | ∞ | 0.49 | 2 | 0 | – | 2 | 1 | 2.05 (0.10–123.44) | 1.00 | 9 | 1 | 0.60 | 3 | 3 | 1.00 (0.13–7.90) | 1.00 | 10 | 4 | 0.24 |
Others | 8 | 5 | 1.73 (0.45–7.31) | 0.55 | 28 | 12 | 0.43 | 11 | 9 | 1.29 (0.43–4.01) | 0.80 | 64 | 42 | 0.15 | 14 | 11 | 1.40 (0.50–3.95) | 0.64 | 72 | 53 | 0.77 |