Keith S. Reisinger1, Michelle L. Hoffman
2, Jin Xu
2, Bradley J. Sullivan
3, Gary S. Marshall
4, Beth W. Nauert
5, David O. Matson
6, Peter E. Silas
7, Florian Schödel
2, Jacqueline O. Gress
2, and Barbara J. Kuter
2. (1) Primary Physicians Research,Inc, 1580 McLaughlin Run Rd, Pittsburgh, PA, USA, (2) Merck Research Laboratories, (3) Pediatrics, Marshfield Clinic, 1000 N. Oak Ave, Marshfield, WI, USA, (4) Pediatric Infectious Diseases, University of Louisville School of Medicine, 571 South Floyd Street; Suite 321, Louisville, KY, (5) Austin Children's Clinic, 621 Radam Lane, Austin, TX, (6) Center for Pediatric Research, Eastern Virginia Medical School, 855 West Brambleton Ave, Norfolk, VA, (7) Wee Care Pediatrics, 1580 West Antelope Drive; Suite 130, Layton, UT
BACKGROUND:
Use of an effective combined measles, mumps, and varicella vaccine (ProQuad®) instead of a second dose of M-M-R®II would facilitate universal immunization of children against all 4 diseases. Second doses of all 4 antigens would likely increse seropositivity rates.
OBJECTIVE:
Demonstrate that ProQuad® can be administered in place of a second dose of M-M-R®II or a second dose of both
M-M-R®II and VARIVAX® at 4 to 6 years of age.
METHOD:
Four- to 6-year-old children (N=799) who previously received M-M-R®II and VARIVAX® were randomly assigned to 1 of 3 double-blinded groups (1:ProQuad®+placebo; 2:M-M-R®II + placebo; 3: M-M-R®II + VARIVAX®). Prevaccination and 6-week postvaccination antibody titers were measured by ELISA. Non-inferiority hypothesis testing of GMTs (<2-fold difference) between groups was performed at the 1-sided 0.05 level (ANOVA). Tolerability information was collected for 42 days postvaccination on a Vaccination Report Card completed by each subject's parent/guadian. The tolerability profile for recipients of ProQuad® was compared to the profiles of the other 2 groups.
RESULT:
Six-week postvaccinantion GMTs for Groups 1 to 3 (respectively) were: measles - 1986, 2047, and 2084mIU/mL; mumps-206,309,296IU/mL; rubella-217,174,154 Ab units/mL; and varicella-322 and 209 gpELISA units/mL (Groups 1 and 3 only). Non-inferiority of postvaccination measles, mumps, and rubella GMTs was demonstrated between Group 1 and Groups 2 and 3 and between Groups 2 and 3. Non-inferiority of 6-week postvaccination varicella GMTs was demonstrated between Groups 1 and 3.
The tolerability profile for ProQuad was comparable with profiles for the other 2 groups.
CONCLUSION:
In healthy children 4 to 6 years of age who were previously administered M-M-R®II and VARIVAX®, ProQuad® can be administered instead of a second dose of M-M-R®II or a second dose of the seperate vaccines, M-M-R®II and VARIVAX®.
LEARNING OBJECTIVES: