Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in Mexico.
OBJECTIVE
To assess the safety and immune responses induced by a 13-valent pneumococcal conjugate vaccine (PCV13) after immunization of infants in Mexico.


METHODS
PCV13 was given with other routine childhood vaccinations to 225 infants in Mexico at ages 2, 4, 6, and 12 months.


RESULTS
The proportions of subjects achieving immunoglobulin G (IgG) concentrations ≥0.35 µg/mL after the infant series and toddler dose were ≥93.1% and ≥96.7%, respectively, for all 13 serotypes. The serotype-specific pneumococcal IgG geometric mean concentrations after the infant series and toddler dose ranged from 1.18 to 9.13 µg/mL and from 1.62 to 15.41 µg/mL, respectively. The most common local reaction and systemic event after each dose were tenderness and irritability, respectively. Most fever was mild; no fever >40.0°C (i.e., severe) was reported. One subject withdrew because of Kawasaki disease 5 days after the first dose of vaccines, but this condition was not considered related to PCV13.


CONCLUSIONS
Overall, PCV13 administered with routine pediatric vaccines was immunogenic and safe in healthy infants in Mexico.
Hospital Para el Niño Poblano, Puebla, Mexico. marycrunch@hotmail.com
Maricruz
M
Gutiérrez Brito
Allison
A
Thompson
Douglas
D
Girgenti
Peter C
PC
Giardina
Denise A
DA
Sarkozy
William C
WC
Gruber
Emilio A
EA
Emini
Daniel A
DA
Scott
D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008800:Mexico; D022242:Pneumococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*
C538862:13-valent pneumococcal vaccine; D022242:Pneumococcal Vaccines