Evaluation
of concomitant injection of a live attenuated varicella vaccine and a
measles-mumps-rubella vaccine in 15-18 month old healthy children
Meng-Yao Lu, Li-Ming Huang, Chin-Yun Lee, Ping-Ing
Lee, Hsiu-Hui Chiu, Hsiu-Yuan Tsai
Dept. of
Pediatrics, National Taiwan University Hospital, Taipei, Chinese Taipei
Background. Vaccination against
MMR has been incorporated into immunization program in many countries and
has led to a dramatic decrease in the incidence of those diseases. Varicella can lead to death and
substantial complications in healthy children. Active immunization is an
effective means to prevent varicella in susceptible individuals.
Objective. To assess reactogenicity and immunogenicity of a
live attenuated varicella vaccine, and measles-mumps-rubella vaccine when
concomitantly administrated, but at different injections sites, in 15-18
months old healthy Taiwanese children.
Materials and Methods. Prior to enrollment parents/guardians
provided written informed consent for the trial which had received ethical
approval, and was conducted according to GCP. 120 subjects were enrolled
and assigned to one of the 2 groups (1:1 ratio) to receive subcutaneously
varicella vaccine (VarilrixTM, GlaxoSmithKline) and MMR vaccine
(MMR-IITM, Merck Sharp & Dohme). Group 1 received the
varicella vaccine at the left arm and the MMR vaccine at the right arm,
while the injection sides of the same two vaccines were reversed in Group
2. Solicited local and general reactions were recorded on diary cards for 3
and 42 days following vaccination, respectively. Anti-measles, -mumps, and
-rubella titers were measured by ELISA (Enzygnost, Behring), and
anti-varicella by immunofluorescence.
Results. Solicited local and
general symptoms are described in the Table below (ITT cohort). Fever was
the major general symptom in both groups. No serious adverse events were reported during the
whole study.
Table 1
|
Local symptoms
|
General symptoms
|
|
VZV
|
MMR
|
|
Group 1
|
3.3
|
1.7
|
11.7
|
|
Group 2
|
3.3
|
5.0
|
8.3
|
In both groups, all subjects
with initially seronegative anti-varicella titers were seropositive one
month after vaccination. Anti-varicella GMTs observed after vaccination
were also similar between both groups (overlapping 95 % CI). Similarly, the
levels of seroprotection and GMTs for anti-measles, -mumps and -rubella
were comparable between both groups (overlapping 95 % CI).
Conclusions. Local symptoms were
comparable for MMR and VZV vaccination. Alternating injection sites did not
influence reactogenicity nor immunogenicity. Concomitant administration of varicella and MMR vaccines
at different injection sites was well tolerated and immunogenic in
Taiwanese children aged 15-18 months.