Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children.
BACKGROUND
A quadrivalent measles, mumps, rubella and varicella vaccine would facilitate universal immunization against all 4 diseases, improve compliance and immunization rates and decrease the number of injections given to children and visits to physicians' offices.


OBJECTIVE
To evaluate 1- and 2-dose regimens of a combined measles, mumps, rubella and varicella vaccine (ProQuad, referred to as MMRV) manufactured with a varicella component of increased potency.


METHODS
In this partially blind, multicenter study, 480 healthy 12- to 23-month-old children were randomized to receive either MMRV and placebo or M-M-RII and VARIVAX. Injections were given concomitantly at separate sites. Subjects randomized to receive MMRV and placebo received a second dose of MMRV 90 days later. Subjects were followed for 42 days after each vaccination for adverse experiences. Immunogenicity was evaluated 6 weeks after each vaccination.


RESULTS
Measles-like rash and fever during days 5-12 were more common after the first dose of MMRV (rash, 5.9%; fever, 27.7%) than after M-M-RII and VARIVAX (rash, 1.9%; fever, 18.7%). The incidence of other adverse events were similar between groups. Response rates were >90% to all vaccine components in both groups. Geometric mean titers to measles and mumps were significantly higher after 1 dose of MMRV than after administration of M-M-RII and VARIVAX. The second dose of MMRV elicited slight to moderate increases in measles, mumps and rubella antibody titers and a substantial increase in varicella antibody titer (from 13.0 to 588.1 glycoprotein antigen-based enzyme-linked immunosorbent assay units/mL).


CONCLUSIONS
A 1- or 2-dose regimen of MMRV is generally well-tolerated when administered to 12- to 23-month-old children and has a safety and immunogenicity profile similar to that of M-M-RII and VARIVAX administered concomitantly.
Shinefield
Henry
H
The University of California San Francisco, USA.
Black
Steve
S
Digilio
Laura
L
Reisinger
Keith
K
Blatter
Mark
M
Gress
Jacqueline O
JO
Brown
Michelle L Hoffman
ML
Eves
Karen A
KA
Klopfer
Stephanie Olsen
SO
Schödel
Florian
F
Kuter
Barbara J
BJ
D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000008:administration & dosage* / Q000276:immunology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage* / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine