Safety and tolerability of zoster vaccine in adults ≥60 years old

Figures & data

Figure 1. Subject Accounting

Table 1. Demographics

	Zoster Vaccine (n = 5983)		Placebo (n = 5997)
	n	(%)	n	(%)
Gender
Male	2468	(41.3)	2472	(41.2)
Female	3515	(58.7)	3525	(58.8)
Age (Years)
60 to 69	3092	(51.7)	3113	(51.9)
70 to 79	1994	(33.3)	1986	(33.1)
≥ 80	897	(15.0)	898	(15.0)
Mean [SD]	70.5 [7.5]		70.4 [7.6]
Median	69		69
Range	60 to 98		60 to 99
Race
Caucasian	5759	(96.3)	5770	(96.2)
African American	109	(1.8)	85	(1.4)
Other	115	(1.9)	142	(2.4)
Region
US	5309	(88.7)	5312	(88.6)
Non-US	674	(11.3)	685	(11.4)
Type of Residence
Independent	5790	(96.8)	5821	(97.1)
Assisted Living	176	(2.9)	162	(2.7)
Nursing Home	17	(0.3)	14	(0.2)

n = Number of subjects receiving given vaccination n = Number of subjects in each category

Table 2. Serious Adverse Experience (SAE) Summary - According to Follow-Up Period

	Zoster Vaccine		Placebo
	(n = 5983)		(n = 5997)
	n	(%)	n	(%)
Primary Safety Follow-Up Period (Day 1 To Day 42 Postvaccination)
Subjects with follow-up	5979	(99.9)	5990	(99.9)
With SAEs^a	84	(1.4)	67	(1.1)
Blood/Lymphatic Disorders	1	(0.0)	0	(0.0)
Cardiac Disorders	19	(0.3)	19	(0.3)
Ear/Labyrinth Disorders	0	(0.0)	1	(0.0)
Eye Disorders	1	(0.0)	0	(0.0)
Gastrointestinal Disorders	8	(0.1)	6	(0.1)
General Disorders	8	(0.1)	4	(0.1)
Hepatobiliary Disorders	3	(0.1)	2	(0.0)
Infections and Infestations	11	(0.2)	13	(0.2)
Injury, Poisoning, and Procedural Complications	5	(0.1)	5	(0.1)
Metabolism and Nutrition Disorders	1	(0.0)	4	(0.1)
Musculoskeletal and Connective Tissue Disorders	6	(0.1)	5	(0.1)
Neoplasms	15	(0.3)	9	(0.2)
Nervous System Disorders	5	(0.1)	7	(0.1)
Psychiatric Disorders	2	(0.0)	2	(0.0)
Renal and Urinary Disorders	4	(0.1)	1	(0.0)
Reproductive System and Breast Disorders	1	(0.0)	2	(0.0)
Respiratory, Thoracic and Mediastinal Disorders	6	(0.1)	4	(0.1)
Skin Disorders	1	(0.0)	0	(0.0)
Vascular Disorders	4	(0.1)	4	(0.1)
With Vaccine-related SAEs^b	2^c	(0.0)	0	(0.0)
Who died	6	(0.1)	5	(0.1)
Secondary Safety Follow-Up Period (Day 1 To Day 182 Postvaccination)
Subjects with follow-up	5979	(99.9)	5990	(99.9)
With SAEs^a	340	(5.7)	300	(5.0)
Blood/Lymphatic Disorders	5	(0.1)	4	(0.1)
Genetic Disorders	0	(0.0)	1	(0.0)
Cardiac Disorders	73	(1.2)	72	(1.2)
Ear/Labyrinth Disorders	0	(0.0)	4	(0.1)
Endocrine Disorders	2	(0.0)	0	(0.0)
Eye Disorders	2	(0.0)	1	(0.0)
Gastrointestinal Disorders	37	(0.6)	29	(0.5)
General Disorders	26	(0.4)	22	(0.4)
Hepatobiliary Disorders	7	(0.1)	8	(0.1)
Immune System Disorders	1	(0.0)	1	(0.0)
Infections and Infestations	57	(1.0)	59	(1.0)
Injury, Poisoning, and Procedural Complications	26	(0.4)	26	(0.4)
Investigations	0	(0.0)	2	(0.0)
Metabolism and Nutrition Disorders	13	(0.2)	12	(0.2)
Musculoskeletal and Connective Tissue Disorders	30	(0.5)	24	(0.4)
Neoplasms	76	(1.3)	58	(1.0)
Nervous System Disorders	25	(0.4)	31	(0.5)
Psychiatric Disorders	6	(0.1)	3	(0.1)
Renal and Urinary Disorders	19	(0.3)	7	(0.1)
Reproductive System and Breast Disorders	2	(0.0)	4	(0.1)
Respiratory, Thoracic and Mediastinal Disorders	28	(0.5)	25	(0.4)
Skin Disorders	2	(0.0)	0	(0.0)
Surgical Procedures	0	(0.0)	1	(0.0)
Vascular Disorders	20	(0.3)	10	(0.2)
With Vaccine-related SAEs^b	2^c	(0.0)	1^d	(0.0)
Who died	24	(0.4)	17	(0.3)

n = Number of subjects receiving given vaccination n = Number of subjects in each category The same subject may appear in different categories, but counted only once in each category ^a SAE System Organ class ^b Determined by the investigator to be possibly, probably, or definitely related to the vaccine ^c Sciatica (Onset Day 4) and Uveitis (Onset Day 5) ^d Lumbar radiculopathy (Onset Day 51)

Table 3. Analysis of Proportion of Subjects Reporting ≥ 1 Serious Adverse Experiences

Safety Follow-Up Period	Zoster Vaccine			Placebo			Zoster Vaccine / Placebo
	m	n	Estimated Risk	m	n	Estimated Risk	Relative Risk	(95% CI)
Day 1 To Day 42 Postvaccination	5979	84	1.41%	5990	67	1.12%	1.26	(0.91, 1.73)
Day 1 To Day 182 Postvaccination	5979	340	5.68%	5990	300	5.01%	1.13	(0.98, 1.32)

m = Number of randomized subjects who were vaccinated and had safety follow-up. n = Number of randomized subjects who were vaccinated and reported at least one serious adverse experiences during the safety follow-up period.

Table 4. Listing of SAEs Resulting in Death (Day 1 to Day 42)

Zoster Vaccine				Placebo
Gender	Age	SAE	Relative Onset Day	Gender	Age	SAE	Relative Onset Day
F	84	metastatic lung cancer respiratory failure	1* 91	F	63	myocardial infarction	4
M	79	emphysema	23	F	80	left ventricular failure	4
F	79	coronary artery disease	23	F	99	acute respiratory failure	15
M	83	obstructive inguinal hernia intestinal obstruction cardiopulmonary failure	36 36 44	M	81	meningitis	21
M	69	glioblastoma multiforme	38	M	73	cerebellar infarction	40
M	85	death^†	39

* Day 1 postvaccination a CT of the chest revealed a large mass in the right lower lobe ^† underlying cause unknown