Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX™) in healthy adults

Figures & data

Table 1. Baseline characteristics

Characteristic	N = 50
Sex, n (%) Male Female	14 (28) 36 (72)
Age, years, median (range)	22 (18–44)
Race, n (%) White	50 (100)
Varicella zoster virus serostatus, n (%) ≥1.25 gpELISA units/mL	24 (48)

gpELISA, glycoprotein enzyme-linked immunosorbent assay.

Figure 1. Changes in geometric mean titer from baseline among adults in Russia administered 2 doses of varicella vaccine 6 weeks apart. A titer of ≥5 gpELISA units/mL 6 weeks after vaccination is considered an approximate correlate of protection for individual vaccinees.

CI, confidence interval; gpELISA, glycoprotein enzyme-linked immunosorbent assay.

Table 2. Injection-site adverse events

n (%)	Participants, n (%)
	Days 1–42post-Dose 1(n = 50)	Days 1–42post-Dose 2(n = 49)	Days 1–42post-Dose 1 or 2(N = 50)
≥1 injection-site AE	24 (48)	28 (57)	36 (72)
Solicited injection-site AEs^a Pain Erythema  0–≤2.4 cm  >2.4–≤5.0 cm  >5.0–≤7.4 cm Swelling  0–≤2.4 cm  >2.4–≤5.0 cm	20 (40) 8 (16) 6 (12) 2 (4) 0 (0) 5 (10) 3 (6) 2 (4)	24 (49) 9 (18) 7 (14) 1 (2) 1 (2) 4 (8) 3 (6) 1 (2)	–
Unsolicited injection-site AEs Pruritus	1 (2)	–	–

^aDetermined by the investigator to be related to the study vaccine; AE, adverse event.

Table 3. Systemic adverse events

n (%)	Participants, n (%)
	Days 1–42 post- Dose 1 (n = 50)	Days 1–42 post- Dose 2 (n = 49)
≥1 systemic AE^a GI disorder Infections and infestations Investigations  Body temperature increased Nervous system disorders  Headache Skin and subcutaneous tissue disorders  Rash vesicular Reproductive system and breast disorders  Dysmenorrhea	19 (38) 4 (8) 5 (10) 5 (10) 8 (16) 7 (14) 4 (8) 3 (6) – –	14 (29) – 3 (6) 3 (6) 5 (10) 5 (10) – – 3 (6) 3 (6)
≥1 vaccine-related systemic AE Pyrexia^b Increased body temperature Facial spasm Headache Rash vesicular	0 (0) 4 (8) 1 (2) 2 (4) 3 (6)	1 (2)^b 3 (6) 0 (0) 0 (0) 1 (2)
Serious AEs	0 (0)	0 (0)
Discontinued due to an AE	0 (0)	0 (0)

^aIncidence ≥5%.

^bPyrexia was reported by a participant with a 38.7°C oral equivalent temperature, which did not fit the protocol-defined definition of fever (i.e. ≥39.0°C oral or oral equivalent); AE, adverse event; GI, gastrointestinal.