Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in Mexico

• Main Authors: Maricruz Gutiérrez Brito, Allison Thompson, Douglas Girgenti, Peter C. Giardina, Denise A. Sarkozy, William C. Gruber, Emilio A. Emini, Daniel A. Scott
• Format: Article
• Language: English
• Published: Pan American Health Organization 2013-06-01
• Series: Revista Panamericana de Salud Pública
• Subjects: Vacunas neumocócicas; seguridad; neumonía; México
• Online Access: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892013000600005&lng=en&tlng=en

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.