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

Abstract

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.

• Authors: Yeshwant K Amdekar, Sanjay K Lalwani, Ashish Bavdekar, S Balasubramanian, Jugesh Chhatwal, Swarna Rekha Bhat, Valsan Philip Verghese, Susan P Tansey, Durga Gadgil, Qin Jiang, Michael Pride, Emilio A Emini, William C Gruber, Daniel A Scott
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 32 Issue 5 Pg. 509-16 (May 2013) ISSN: 1532-0987 [Electronic] United States
• PMID: 23190777 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• 13-valent pneumococcal vaccine
• Antibodies, Bacterial
• Heptavalent Pneumococcal Conjugate Vaccine
• Pertussis Vaccine
• Pneumococcal Vaccines
• Poliovirus Vaccines

Topics

• Antibodies, Bacterial (blood, immunology)
• Double-Blind Method
• Drug-Related Side Effects and Adverse Reactions
• Female
• Heptavalent Pneumococcal Conjugate Vaccine
• Humans
• Immunization Schedule
• Infant
• Male
• Pertussis Vaccine (administration & dosage)
• Pneumococcal Vaccines (administration & dosage, adverse effects, immunology)
• Poliovirus Vaccines (administration & dosage)
• Streptococcus pneumoniae (immunology)