Reactogenicity, safety and immunogenicity of live
attenuated varicella vaccine (Oka‑strain) in healthy seronegative children
from 1 to 12 years of age
Satari
H.I.1, Hadinegoro S.R.H.1, Abdurrachman H.1,
Han H.H.2, Bock H.L.2
1 Ciptomangunkusumo General Hospital, Indonesia; 2 GlaxoSmithKline,
Rixensart, Belgium
Objective: To evaluate
the reactogenicity, safety and immunogenicity of one dose of live
attenuated varicella vaccine (Oka-strain) in healthy children from 12
months of age up to and including 12 years of age.
Method: 300 subjects
were enrolled and allocated to one of the three age groups (12 months to
< 3 years, 3 to < 7 years, 7 to 12 years), to receive the live
attenuated varicella vaccine (Oka strain, VarilrixTM stored at
+2¡ãC to +8¡ãC, GlaxoSmithKline). A single dose of vaccine was administered
subcutaneously to healthy children at 12 months to 12 years of age. The
incidence of solicited local (7-day follow-up period) and general symptoms
(3-day follow-up period for fever and 42-day follow-up period for rash), as
well as unsolicited symptoms (42-day follow-up period), were recorded on
diary cards. Sera were collected immediately before vaccination and 42 days
after vaccination. Antibody level against varicella were measured by an
immunofluorescence assay. Seroconversion was defined as the appearance of
antibodies titers ³ 4 dilutions-1
in initially seronegative subjects (titer < 4 dilutions-1).
Results: The nature
of symptoms reported after vaccination was more general than local (11.9%
general symptoms compared to 0.3% local symptoms). One case of soreness
(Grade 1) was reported during the 7-day follow-up period resolving within 2
days of onset. Grade 3 fever (³ 39.0¡ã C) was the more
prevalent solicited general symptoms, reported following vaccination (1.7 %
of subjects). Three subjects reported rash, but no grade 3. These symptoms
resolved within a maximum of 5 days from the date of onset. All enrolled
subjects were seronegative for anti-varicella antibodies before
vaccination. At six weeks after vaccination, all but one subject had
seroconverted. Anti-varicella GMTs were 136.7 in the younger age group (12
months to < 3 years), 122.3 in the mid-age group (3 to < 7 years),
and 87.2 in the older age group (7 to 12 years), with overlapping 95 % CI.
Conclusions:
GlaxoSmithKline¡¯s live attenuated varicella vaccine (Oka-strain, VarilrixTM)
was found to be safe, well tolerated and immunogenic when administered as a
single dose primary vaccination to healthy, seronegative children from 1 to
12 years of age.