DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine vaccines in India.

Author(s): Amdekar YK(1), Lalwani SK, Bavdekar A, Balasubramanian S, Chhatwal J, Bhat SR, Verghese VP, Tansey SP, Gadgil D, Jiang Q, Pride M, Emini EA, Gruber WC, Scott DA.

Affiliation(s): Author information: (1)Jaslok Hospital and Research Center, Mumbai, India. ykasya@gmail.com

Publication date & source: 2013, Pediatr Infect Dis J. , 32(5):509-16

BACKGROUND: The childhood burden of disease attributable to Streptococcus pneumoniae is particularly high in India. The immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) were compared with 7-valent pneumococcal conjugate vaccine (PCV7) in a randomized, active-controlled, double-blind trial conducted at 12 sites in India. METHODS: Healthy infants received PCV13 or PCV7 at 6, 10, and 14 weeks of age (infant series) and at 12 months of age (toddler dose), along with routine pediatric vaccinations. Immunoglobulin G responses against the 13 pneumococcal serotypes were evaluated 1 month after the infant series and after the toddler dose. Pertussis and poliomyelitis immune responses were assessed 1 month after the infant series. Safety and tolerability also were assessed. RESULTS: The immunogenicity results for the 7 common serotypes and the concomitant vaccines (whole-cell pertussis and oral poliovirus) were similar for subjects receiving PCV13 and subjects receiving PCV7. Immune responses to the 6 additional serotypes were higher in the PCV13 group compared with the PCV7 group. PCV13 and PCV7 had similar safety and tolerability profiles. CONCLUSIONS: PCV13 has immunogenicity similar to PCV7 in response to the 7 common serotypes, and has generally higher immunogenicity in response to the 6 additional serotypes. PCV13 may provide added protection against pneumococcal disease caused by the additional 6 serotypes and does not interfere with immune responses to whole-cell pertussis and oral poliovirus vaccines. PCV13 has an acceptable safety profile in both infants and toddlers, comparable with that of PCV7.

Page last updated: 2014-11-30

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017