Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar) administered in previously unvaccinated Spanish children aged 24 to 36 months.
This study evaluates the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar) in 115 children, aged 2-3 years (24-36 months), who have not been previously vaccinated with Prevenar.


RESULTS



RESULTS
As for local reactions, 40% of children reported erythema, 32.2% induration and 39.1% tenderness at the injection site. Regarding systemic reactions, fever > or 38 C was recorded in 7% of patients. Other commonly reported events were decreased appetite (24.3%), restlessness (20%), and fussiness (18.3%).
After vaccination, more than 98% of the subjects achieved antibody levels of > or = 0.15 microg/mL for all seven serotypes and more than 95% achieved antibody levels > or = 0.50 microg/mL for all serotypes.


CONCLUSIONS
Pneumococcal seven-valent conjugate vaccine (Prevenar) was safe, well tolerated and highly immunogenic when administered in previously unvaccinated children aged 14-36 months.
de Arístegui Fernández
Javier
J
Pediatric Department, Basurto Hospital, Bilbao, Spain. aristegi@hbas.osakidetza.net
Cos Arregui
Begoña
B
Zurimendi Carril
Ana
A
Alday Esteban
Ma Victoria
MV
Alzua Ruiz
Javier
J
De la Fuente Jausoro
Emma
E
Maturana San Pedro
Inmaculada
I
López Michelena
Ma José
MJ
Mourelo Carballo
Carlos
C
Quintanilla Sánchez
Maria Isabel
MI
Abad Therón
Inmaculada
I
Cimino
Carolyn O
CO
Fletcher
Mark A
MA
Pérez Domínguez
Ana
A
D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007223:Infant; D008297:Male; D011008:Pneumococcal Infections / Q000276:immunology* / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D013030:Spain; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
D000907:Antibodies, Bacterial; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate