Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine.
In this open, randomized, comparative study (105908/NCT00353288), 458 age-stratified children (15 months-2 years and 2-6 years) previously primed with MMR received one dose of either a combined MMRV vaccine (Priorix-Tetra, MMRV group) or concomitant MMR and varicella vaccines (Priorix and Varilrix, MMR+V group), followed 42-56 days later by another dose of varicella vaccine (Varilrix) in both groups. Post-vaccination measles, mumps and rubella seropositivity rates and antibody geometric mean titers (GMTs) were high (99.5% for anti-measles and 100% for anti-mumps and anti-rubella) in both vaccine groups. In the two age strata, varicella seroconversion rates were, post-dose 1: > or =97.6% (MMRV), > or =96.6% (MMR+V) and, post-dose 2: 100% in both groups. Post-dose 2, anti-varicella GMTs increased respectively 14.1- and 12.6-fold (MMRV), and 9.8- and 13.1-fold (MMR+V). Both vaccine regimens were well-tolerated. Post-dose 1, the incidence of any solicited local symptom during the 4-days follow-up was < or =28.2% (MMRV) and < or =19.8% (MMR+V) and the incidence of fever >39.5 degrees C (rectal temperature) within 15 days was < or =2.8% (MMRV) and < or =2.6% (MMR+V). This MMRV vaccine appears an immunogenic and safe substitute for a second dose of MMR vaccine in young children. The increase in anti-varicella antibodies observed after a second dose of varicella vaccine supports a two-dose schedule for varicella-containing vaccine.
Gillet
Y
Y
Hôpital Femme Mère Enfant, Urgences Pédiatriques Lyon France, 59 Bd Pinel, 69500 BRON, France. yves.gillet@chu-lyon.fr
Steri
G C
GC
Behre
U
U
Arsène
J P
JP
Lanse
X
X
Helm
K
K
Esposito
S
S
Meister
N
N
Desole
M G
MG
Douha
M
M
Willems
P
P
D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000009:adverse effects* / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000009:adverse effects* / Q000276:immunology*; D017778:Vaccines, Combined
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine