Table 2.

Most Common Adverse Events Observed Within 30 Days of the First Vaccination (Reported in ≥3% of Patients in Any Treatment Group; Primary Phase)—Exposed Set

Adverse Event	RSV120_dTpa (n = 101)	RSV120_Placebo (n = 101)	RSV60_dTpa (n = 103)	RSV60_Placebo (n = 102)	dTpa_Placebo (n = 102)
Headache	8 (7.9) [3.5–15.0]	5 (5.0) [1.6–11.2]	6 (5.8) [2.2–12.2]	4 (3.9) [1.1–9.7]	2 (2.0) [.2–6.9]
Upper respiratory tract infection	8 (7.9) [3.5–15.0]	8 (7.9) [3.5–15.0]	4 (3.9) [1.1–9.6]	2 (2.0) [.2–6.9]	5 (4.9) [1.6–11.1]
Nasopharyngitis	1 (1.0) [.0–5.4]	1 (1.0) [.0–5.4]	0 (0) [.0–3.5]	7 (6.9) [2.8–13.6]	3 (2.9) [.6–8.4]
Myalgia	2 (2.0) [.2–7.0]	4 (4.0) [1.1–9.8]	1 (1.0) [.0–5.3]	4 (3.9) [1.1–9.7]	0 (0) [.0–3.6]
Injection-site bruising	1 (1.0) [.0–5.4]	0 (0) [.0–3.6]	4 (3.9) [1.1–9.6]	1 (1.0) [.0–5.3]	2 (2.0) [.2–6.9]
Administration-site erythema	0 (0) [.0–3.6]	2 (2.0) [.2–7.0]	4 (3.9) [1.1–9.6]	1 (1.0) [.0–5.3]	0 (0) [.0–3.6]
Fatigue	2 (2.0) [.2–7.0]	3 (3.0) [.6–8.4]	1 (1.0) [.0–5.3]	2 (2.0) [.2–6.9]	1 (1.0) [.0–5.3]
Oropharyngeal pain	3 (3.0) [.6–8.4]	2 (2.0) [.2–7.0]	1 (1.0) [.0–5.3]	1 (1.0) [.0–5.3]	0 (0) [.0–3.6]

Data are No. (%) [95% confidence interval].

Abbreviations: dTpa, diphtheria, tetanus, and acellular pertussis; dTpa_placebo, participants who received dTpa and placebo; RSV, respiratory syncytial virus; RSV60_dTpa, participants who received RSV60 and dTpa; RSV60_placebo, participants who received RSV60 and placebo; RSV120_dTpa, participants who received RSV120 and dTpa; RSV120_placebo, participants who received RSV120 and placebo.