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Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e31822a8541
Online-Only: Original Studies

Response to Primary and Booster Vaccination With 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine in Korean Infants

Kim, Chang-Hwi MD*; Kim, Jung Soo MD; Cha, Sung-Ho MD, PhD; Kim, Kwang-Nam MD§; Kim, Jong-Duck MD; Lee, Kyung Yil MD; Kim, Hwang Min MD**; Kim, Jong-Hyun MD; Hyuk, Sang Ma MD††; Hong, Jung-Yun MD‡‡; Park, Su Eun MD§§; Kim, Yun-Kyung MD¶¶; Kim, Nam Hee MD‖‖; Fanic, Aurélie MSc***; Borys, Dorota MD***; Ruiz-Guiñazù, Javier MD***; Moreira, Marta MD***; Schuerman, Lode MD***; Kim, Kyung-Hyo MD†††

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Abstract

Background: This randomized single-blind study in Korea evaluated noninferiority of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) versus the 7-valent pneumococcal conjugate vaccine (7vCRM) when both were coadministered with H. influenzae type b (Hib) conjugate vaccine, as opposed to coadministration with diphtheria-tetanus-acellular pertussis-based combination vaccines in previous studies.

Methods: Infants received 3 primary doses at 2, 4, and 6 months and a booster dose at 12 to 18 months of PHiD-CV (N = 374) or 7vCRM (N = 129), both coadministered with Hib vaccine. Immune responses were measured 1 month postdose 3 and postbooster using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay.

Results: PHiD-CV-induced antibody responses against each of the vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM was demonstrated for all 10 PHiD-CV serotypes in terms of percentages of subjects reaching an antibody concentration ≥0.2 μg/mL after primary vaccination. Postprimary and postbooster, percentages of subjects with antibody concentration ≥0.2 μg/mL or opsonophagocytic activity titer ≥8 were generally consistent between groups for each pneumococcal serotype common to both vaccines. The safety and reactogenicity profiles of PHiD-CV and 7vCRM were generally comparable after both primary and booster vaccination.

Conclusions: In this Korean study, 3-dose PHiD-CV priming followed by a booster dose was immunogenic for all 10 vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM in terms of enzyme-linked immunosorbent assay threshold responses postpriming was demonstrated. The safety and reactogenicity profiles of both vaccines when coadministered with Hib vaccine were generally comparable.

© 2011 Lippincott Williams & Wilkins, Inc.

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