Table 2.

Clinical and virologic responses of infants and children following rHPIV3cp45 or placebo.

	Dose 1		P-value	Dose 2		P-value
	Vaccine	Placebo		Vaccine	Placebo
Total subjects (N)	27	13		26	13
Subjects with sera collected (N)	26	13		26	13
N (%) of evaluable infecteda	25/26 (96)	3/13 (23)	<0.001	9/26 (35)	0 (0)	0.018
N (%) of evaluable shedding vaccine virus	24/27 (89)	0/13 (8)	<0.001	9/26 (35)	0 (0)	0.018
Median days of shedding (range)b	12 (6–15)	N/A	–	6 (3–8)	N/A	–
Mean peak viral titer in log10 TCID50/mLc (SD)	3.4 (1.0)	–	–	1.5 (0.92)	–	–
N (% of subjects with sera) with 4-fold rise in antibody titer	23 (88)	3 (23)	<0.001	6 (23)	0 (0)	0.081
Median log2-fold change in HAI antibody titer (range)	5 (0–7)	0 (0–6)	<0.001	0 (−1 to 5)	0 (0–0)	0.017
N patients with illness (%)
Fever	3 (11)	2 (15)	1.00	3 (12)	1 (8)	1.00
Upper respiratory tract infection	9 (33)	4 (31)	1.00	7 (27)	2 (15)	0.689
Rhinorrhea	9 (33)	4 (31)	1.00	7 (27)	2 (15)	0.69
Pharyngitis	0 (0)	1 (8)	0.33	0 (0)	0 (0)	–
Lower respiratory tract infection	0 (0)	0 (0)	–	0 (0)	0 (0)	–
Cough	3 (11)	0 (0)	0.538	0 (0)	0 (0)	–
Otitis media	1 (4)	1 (8)	1.00	0 (0)	0 (0)	–
Any respiratory or febrile illness	11 (41)	4 (31)	0.730	9 (35)	3 (23)	0.714

^aInfection was defined as vaccine virus isolation and/or ≥4-fold rise in serum antibody titer.

^bDuration of shedding was calculated for infected subjects only, and was defined as the time between inoculation and the last day on which vaccine virus was recovered.

^cMean peak titer of virus shed was calculated for infected subjects only.