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.
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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)
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Chemical References |
- 13-valent pneumococcal vaccine
- Antibodies, Bacterial
- Heptavalent Pneumococcal Conjugate Vaccine
- Pertussis Vaccine
- Pneumococcal Vaccines
- Poliovirus Vaccines
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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)
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