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.

 
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