Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants

Figures & data

Table 1. Premature infant accounting*

	DTaP-IPV-Hib-HepB	Control
Protocol 005	29	18
Protocol 006	57	9
Protocol 007	14	7
Protocol 008	6	15
PRI01C	4	n/a
Total^†	111 (safety) 110 (immunogenicity)	49

*identified via medical history terms consistent with prematurity (“premature baby/delivery” and/or “low birth weight baby”).

^†one premature participant in the Phase II Protocol 004 study that was included in the safety summary was not included for the immunogenicity analyses.

Table 2. Analysis of the clinical adverse events after any dose of vaccine in the overall and premature populations for DTaP-IPV-Hib-HepB and control vaccines

Number of Participants	DTaP-IPV-Hib-HepB Study Population				Control Study Population
	Overall		Premature		Overall		Premature
	(N = 5234)		(N = 111)		(N = 2302)		(N = 49)
	n	%	n	%	n	%	n	%
With ≥1 AEs (Days 1 to 15)	5030	96.3	107	97.3	2224	96.9	43	87.8
Injection-site AEs (Days 1 to 15)	4419	84.6	83	75.5	1957	85.3	37	75.5
Solicited injection-site AEs (Days 1 to 5)	4393	84.1	83	75.5	1946	84.8	37	75.5
Systemic AEs (Days 1 to 15)	4974	95.2	108	96.4	2197	95.7	42	85.7
Solicited systemic AEs (Days1 to 5)	4893	93.7	104	94.5	2170	94.6	41	83.7
Unsolicited systemic AEs (Days 1 to 15)	2594	49.7	46	41.8	1222	53.2	17	34.7
Serious AEs (Days 1 to 15) *	77	1.5	2	1.8	32	1.4	2	4.1
Serious AEs (Entire Collection Period) *	202	3.9	5	4.5	84	3.7	6	12.2
Serious vaccine-related AEs ^*†	12	0.2	0	0.0	5	0.2	1	2.0
Who died *	6	0.1	0	0.0	1	0.0	1	2.0
Discontinued due to AEs	12	0.2	0	0.0	10	0.4	1	2.0

N = number of subjects in the safety analysis population; n = number of subjects in each category.

*In Protocol 004, Serious AEs were collected throughout the duration of the study. In Protocols 005 and 006, Serious AEs were collected up to 180 days after dose 3 and up to 14 days following the Toddler dose, and Serious AEs leading to death or vaccine-related were collected throughout the study. In Protocols 007, 008 and PRI01C, Serious AEs were collected up to 14 days after each dose, and Serious AEs leading to death or vaccine-related were collected throughout the study.

^†Determined by the investigator to be related to the vaccine.

Figure 1. Selected systemic and injection-site adverse events days 1 to 15 following any dose of vaccination

Vaccination schedules for DTaP-IPV-Hib-HepB Group were as follows: at 2, 4, 6 months in Protocols 004, 005 and 006, plus at 15 months in Protocol 004; at 2, 3, 4 months for Protocol 007 and PRI01C plus 12 months in protocol 007; and at 2, 4 and 11-12 months in Protocol 008.

Adverse events occurring after the Toddler dose for the Protocols 005, 006 and PRI01C were not included.

Figure 2. Selected injection-site ae days 1 to 15 following any dose vaccination

Vaccination schedules for DTaP-IPV-Hib-HepB Group were as follows: at 2, 4, 6 months in Protocols 004, 005 and 006, plus at 15 months in Protocol 004; at 2, 3, 4 months for Protocol 007 and PRI01C plus 12 months in protocol 007; and at 2, 4 and 11-12 months in Protocol 008.

AEs occurring after the Toddler dose for the Protocols 005, 006 and PRI01C were not included.

Figure 3. Immune responses after the infant series (2, 4, and 6 months) for protocol 005 and protocol 006 combined (see Supplemental Table 3 for the response definitions by antigen)

The 95% CI for response rate was based on the exact binomial method by Clopper and Pearson.