Table 2.
Proportion of participants with injection site and systemic reactions after Tdap or saline placebo administration, by study group.
| Tdap Antepartum/Placebo Postpartum (N=33) | Placebo Antepartum/Tdap Postpartum (N=15) | Non-Pregnant Women (N=32) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Tdap | Placebo | Placebo | Tdap | Tdap | |||||||
| Symptom | No. (%) | 95% CI | No. (%) | 95% CI | No. (%) | 95% CI | No. (%) | 95% CI | No. (%) | 95% CI | |
| Local Symptoms | Pain at Injection Site1 | 25 (75.8) | (57.7, 88.9) | 5 (15.2) | (5.1, 31.9) | 2 (13.3) | (1.7, 40.5) | 11 (73.3) | (44.9, 92.2) | 25 (78.1) | (60.0, 90.7) |
| Erythema/Redness at Injection Site1 | 3 (9.1) | (1.9, 24.3) | 1 (3.0) | (0.1, 15.8) | 1 (6.7) | (0.2, 31.9) | 0 | (0.0, 21.8) | 2 (6.3) | (0.8, 20.8) | |
| Induration/Swelling at Injection Site1 | 3 (9.1) | (1.9, 24.3) | 0 | (0.0, 10.6) | 0 | (0.0, 21.8) | 2 (13.3) | (1.7, 40.5) | 1 (3.1) | (0.1, 16.2) | |
| Any Injection Site Symptom2 | 26 (78.8) | (61.1, 91.0) | 6 (18.2) | (7.0, 35.5) | 3 (20.0) | (4.3, 48.1) | 12 (80.0) | (51.9, 95.7) | 25 (78.1) | (60.0, 90.7) | |
| Systemic Symptoms | Fever3 (Oral temperature ≥ 100.5) | 1 (3.0)4 | (0.1, 15.8) | 5 (15.2)5 | (5.1, 31.9) | 0 | (0.0, 21.8) | 4 (26.7)5 | (7.8, 55.1) | 3 (9.4)4 | (2.0, 25.0) |
| Headache1 | 11 (33.3) | (18.0, 51.8) | 5 (15.2) | (5.1, 31.9) | 3 (20.0) | (4.3, 48.1) | 7 (46.7) | (21.3, 73.4) | 11 (34.4) | (18.6, 53.2) | |
| Malaise (Feeling Unwell)1 | 4 (12.1) | (3.4, 28.2) | 3 (9.1) | (1.9, 24.3) | 2 (13.3) | (1.7, 40.5) | 3 (20.0) | (4.3, 48.1) | 6 (18.8) | (7.2, 36.4) | |
| Myalgia (Muscle Aches and Pains)1 | 5 (15.2) | (5.1, 31.9) | 3 (9.1) | (1.9, 24.3) | 0 | (0.0, 21.8) | 3 (20.0) | (4.3, 48.1) | 6 (18.8) | (7.2, 36.4) | |
| Any Systemic Symptom6 | 12 (36.4) | (20.4, 54.9) | 9 (27.3) | (13.3, 45.5) | 3 (20.0) | (4.3, 48.1) | 11 (73.3) | (44.9, 92.2) | 17 (53.1) | (34.7, 70.9) | |
| Any Symptom | Any Symptom7 | 26 (78.8) | (61.1, 91.0) | 13 (39.4) | (22.9, 57.9) | 5 (33.3) | (11.8, 61.6) | 14 (93.3) | (68.1, 99.8) | 27 (84.4) | (67.2, 94.7) |
Fisher’s exact p-values > 0.35 comparing individual symptom rates after Tdap doses among Tdap antepartum, Tdap postpartum and non-pregnant women groups.
Fisher’s exact p-values > 1 comparing any injection site symptom rates after Tdap doses among Tdap antepartum, Tdap postpartum and non-pregnant women groups.
Fisher’s exact p-values p=0.044 for fever rates after receipt of Tdap when comparing Tdap antepartum, Tdap postpartum and non-pregnant women groups. This significant difference is attributable to the increased rate in the subjects that received Tdap postpartum (26.7%).
p=0.36 for rates of fever in women who received Tdap antepartum (3.0%) and non-pregnant women (9.4%).
p=0.43 for rates of fever in women who received placebo postpartum (15.2%) and women who received Tdap postpartum (26.7%).
p =0.055 when comparing any systemic symptom rates after Tdap doses among Tdap antepartum, Tdap postpartum and non-pregnant women groups.
p=0.53 for rates of any injection site or systemic symptoms after Tdap doses among Tdap antepartum, Tdap postpartum and non-pregnant women groups.