Clinical
consistancy of three lots of live attenuated Measles (Schwarz strain) -
Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) vaccine in 12 to 24
months old healthy Filipino children
Gatchalian
S.R.1, Han H.H.2, Bock H.L.2, Cordero-Yap
L.3, Rogacion J.4, Lu-Fong M.5, Carlos J.6
1 Research Institute for Tropical
Medicine, Manilla, Philippines;
2 GlaxoSmithKline, Rixensart, Belgium;
3 Holy Child Hospital, Pamanga,
Philippines;
4 St. Dominic Hospital, Cavite,
Philippines;
5 Cardinal Santos Medical Center, San
Juan, Philippines;
6 University of the East Ramon Magsaysay,
Quezon City, Philippines
Objective: To assess the safety, reactogenicity
and immunogenicity of three lots of live attenuated measles-mumps-rubella
vaccine in healthy children aged 12 to 24 months.
Method:
195
subjects were randomly allocated to three groups to receive three different
lots of live attenuated measles-mumps-rubella vaccine. The vaccine lots
contain slightly various virus titres of the Schwarz measles strain, the
RIT 4385 mumps strain and the RA 27/3 rubella strain. A single dose of
vaccine was administered subcutaneously to the healthy children at 12 to 24
months of age. Solicited local and general reactions as well as all
unsolicited adverse events were recorded on diary cards during 42 days
following vaccination. Sera were collected immediately before vaccination
and 60 days after vaccination. Antibody levels against measles, mumps and
rubella were measured by ELISA.
Results: Local symptoms (pain at injection site within 30 minutes, pain, redness and
swelling within 4 days of injection) were reported less frequently than
general symptoms (fever, rash and parotid gland swelling). There were no
statistically significant difference for the incidence of local symptoms, general
symptoms and all other unsolicited adverse events between the three groups.
Pain (burning/stinging) at the injection site within 30 minutes after
vaccination was reported in 3.1%, 1.6% and 0% of subjects in Group 1, 2 and
3, respectively. Rash was reported in 6.2%, 1.6% and 4.7% of subjects and
fever >39.5°C in 9.2%, 6.3% and 4.7% of subjects, in Group 1,
2 and 3, respectively. The majority of fever cases occurred in all three
groups during the second week after vaccination. Immunogenicity profiles were
also comparable between the three groups.
Conclusion: The three lots of GlaxoSmithKline’s
live attenuated measles-mumps-rubella vaccine were shown to be safe, well
tolerated and immunogenic, when given to healthy children at 12 to 24
months of age, and consistent with regard to both reactogenicity and
immunogenicity.