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.
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