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Table 2 Incidence of fever reported during the 15-day (days 0–14) and results of between-group exploratory analyses, post-dose 1 (total vaccinated cohort)

From: Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study

 

n (%)

 

Difference in percentage (Var-HSA minus Var + HSA), % (95% CI)

Group Var-HSA

Group Var + HSA

Post-dose 1

N = 612

N = 614

 

Any

83 (13.6)

92 (15.0)

−1.42 (−5.36–2.51)

≥38.0 °C

83 (13.6)

92 (15.0)

−1.42 (−5.36–2.51)

related

53 (8.7)

33 (5.4)

3.29 (0.43–6.23)

> 38.5 °C

42 (6.9)

45 (7.3)

−0.47 (−3.39–2.45)

related

21 (3.4)

14 (2.3)

1.15 (−0.75–3.15)

> 39.0 °C

24 (3.9)

32 (5.2)

−1.29 (−3.72–1.08)

related

12 (2)

10 (1.6)

0.33 (−1.25–1.96)

> 39.5 °C

18 (2.9)

13 (2.1)

0.82 (−0.99–2.71)

related

9 (1.5)

1 (0.2)

1.31 (0.38–2.63)

> 40.0 °C

5 (0.8)

5 (0.8)

0 (−1.17–1.18)

related

1 (0.2)

0 (0.0)

0.16 (−0.46–0.92)

Medical advice

19 (3.1)

28 (4.6)

−1.46 (−3.72–0.72)

  1. Group Var-HSA, participants receiving varicella vaccine produced without HSA (human albumin serum); Group Var + HSA, participants receiving varicella vaccine containing HSA; n (%), number (percentage) of participants reporting the symptom at least once, CI confidence interval; N number of participants with available results
  2. Note: Bolded values indicate that the primary objective was achieved (the upper limit of the 95% CI ≤5% for the between-group difference in incidence of fever > 39.0 °C). All other comparisons were exploratory, without adjustment for multiplicity; therefore, the results should be interpreted with caution