Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life.
BACKGROUND
Measles, mumps, and rubella (MMR) and varicella (V) vaccines are often coadministered at 1 clinic visit. This study (104389/NCT00127023) was undertaken to assess the immunogenicity and safety of a new refrigerator-stable tetravalent MMRV vaccine after 1 dose and after 2 doses administered during the second year of life.


METHODS
Nine hundred seventy healthy children aged 10-21 months received 2 doses of MMRV vaccine (Priorix-Tetra; GlaxoSmithKline Biologicals, Rixensart, Belgium) 42 days apart (MMRV group; N = 732) or 1 dose of MMR vaccine (Priorix) coadministered with varicella vaccine (Varilrix) followed by a second dose of only MMR vaccine 42 days later (MMR + V group; N = 238).


RESULTS
Observed seroconversion rates for measles, mumps, rubella, and varicella antibodies 42 days postdose 1 were 94.5%, 96.1%, 99.7%, 95.5% in the MMRV group and 93.4%, 93.6%, 98.1%, 95.6% in the MMR + V group. Respective seroconversion rates postdose 2 were 98.3%, 99.4%, 99.7%, 99.7% in the MMRV group and 97.6%, 99.5%, 100%, 97.5% in the MMR + V group. Observed antimeasles and antimumps geometric mean titers (GMTs) were higher after each dose in the MMRV group than in the MMR + V group. Antivaricella GMT increased 21-fold in the MMRV group postdose 2, and was markedly higher than in the MMR + V group who did not receive a second dose of varicella (1903.3 and 80.3 dilution, respectively). Both vaccine regimens were generally well-tolerated in terms of local reactions, fever >39.5 degrees C, and vaccine-related rashes.


CONCLUSIONS
Both after 1 dose and after 2 doses, the MMRV vaccine was at least as immunogenic as concomitant MMR and varicella vaccination suggesting that it could be suitable for use according to current vaccination schedules.
Schuster
Volker
V
Hospital for Children and Adolescents, University of Leipzig, Leipzig, Germany. volker.schuster@medizin.uni-leipzig.de
Otto
Walter
W
Maurer
Lothar
L
Tcherepnine
Patricia
P
Pfletschinger
Ulrich
U
Kindler
Klaus
K
Soemantri
Peter
P
Walther
Uta
U
Macholdt
Ute
U
Douha
Martine
M
Pierson
Patrice
P
Willems
Paul
P
D000914:Antibodies, Viral / Q000097:blood; D002644:Chickenpox / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005260:Female; D005858:Germany; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D008457:Measles / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D008459:Measles virus / Q000276:immunology; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D009107:Mumps / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D009109:Mumps virus / Q000276:immunology; D012409:Rubella / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D012412:Rubella virus / Q000276:immunology; D016896:Treatment Outcome; D017778:Vaccines, Combined
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine