Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad).
BACKGROUND
A combination measles, mumps, rubella, and varicella vaccine (ProQuad, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad would result in fewer injections for children and would facilitate universal immunization against all four diseases.


OBJECTIVE
To describe the combined results obtained from the studies conducted during the clinical development program for ProQuad.


METHODS
A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad in five controlled clinical trials. M-M-R II and VARIVAX were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA).


RESULTS
A single dose of ProQuad in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R II and VARIVAX and was generally well tolerated. ProQuad can be used concomitantly with other vaccines (hepatitis B and Hoemophilus influenzoe b). A higher rate of fever was reported after 1 dose of ProQuad compared to M-M-R II and VARIVAX, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad in 12- to 23-month-olds and use of ProQuad in place of M-M-R II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad was lower than that following the initial dose.


CONCLUSIONS
A single dose of ProQuad is as immunogenic as M-M-R II and VARIVAX and is well tolerated in a 1- or 2-dose schedule. ProQuad should easily fit into the routine immunization schedule.
Kuter
Barbara J
BJ
Merck Research Laboratories, P 0. Box 4, West Point 19426, Pennsylvania, USA. barbara_kuter@merck.com
Brown
Michelle L Hoffman
ML
Hartzel
Jonathan
J
Williams
Wendy R
WR
EvesiKaren
A
A
Black
Steve
S
Shinefield
Henry
H
Reisinger
Keith S
KS
Marchant
Colin D
CD
Sullivan
Bradley J
BJ
Thear
Marci
M
Klopfer
Stephanie
S
Xu
Jin
J
Gress
Jacqueline O
JO
Schödel
Florian
F
D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000009:adverse effects* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007223:Infant; D016015:Logistic Models; D008458:Measles Vaccine / Q000009:adverse effects* / Q000276:immunology; D009108:Mumps Vaccine / Q000009:adverse effects* / Q000276:immunology; D016032:Randomized Controlled Trials as Topic; D012411:Rubella Vaccine / Q000009:adverse effects* / Q000276:immunology; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D008458:Measles Vaccine; D009108:Mumps Vaccine; D012411:Rubella Vaccine; D017778:Vaccines, Combined