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.
From the *College of Medicine, Soonchunhyang University, Bucheon, Republic of Korea; †College of Medicine, Chonbuk National University, Jeonju, Republic of Korea; ‡College of Medicine, Kyunghee University, Seoul, Republic of Korea; §College of Medicine, Hallym University, Seoul, Republic of Korea; ¶College of Medicine, Wonkwang University, Iksan, Republic of Korea; ‖College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; **Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea; ††Changwon Fatima Hospital, Changwon, Republic of Korea; ‡‡College of Medicine, Jeju National University, Jeju, Republic of Korea; §§College of Medicine, Pusan National University, Pusan, Republic of Korea; ¶¶College of Medicine, Korea University, Ansan, Republic of Korea; ‖‖College of Medicine, InJe University, Goyang, Republic of Korea; ***Global Clinical Research and Development Department, GlaxoSmithKline Biologicals, Wavre, Belgium; and †††College of Medicine, Ewha Womans University, Seoul, Republic of Korea.
Accepted for publication June 20, 2011.
Supported by GlaxoSmithKline (GSK) Biologicals, Rixensart, Belgium (study numbers: 110808 and 112933; available at: www.ClinicalTrials.gov: NCT00680914 and NCT00911144). GSK Biologicals was involved in all stages of the study conduct and analysis. GSK Biologicals also took in charge all costs associated to the development and the publishing of the present manuscript.
S.H.C., J.Y.H., H.M.K., K.Y.L., and S.E.P. declare they have no conflict of interest; C.H.K., J.D.K., J.H.K., J.S.K., K.H.K., K.N.K., N.H.K., Y.K.K., and S.H.M. received travel and/or investigator fees from GSK Biologicals; in addition, K.N.K., Y.K.K., and S.H.M. received payment for lectures from GSK Biologicals, J.H.K. received honoraria from GSK Korea and Sanofi-Pasteur and N.H.K. received grants from LG Life Science. L.S., D.B., M.M., and J.R.G. declare they are employed by and own stocks of GSK Biologicals. A.F. works as a consultant for GSK Biologicals.
The authors have no other funding or conflicts of interest to disclose.
Prevenar/Prevnar is a trademark of Pfizer Inc.; Synflorix and Hiberix are trademarks of the GlaxoSmithKline group of companies.
The corresponding author had full access to the data and final responsibility for submission of the publication.
Address for correspondence: Kyung-Hyo Kim, MD, Ewha Womans University, School of Medicine 911–1 Mokdong Yangcheon-Ku, Seoul 158–710, Republic of Korea. E-mail: email@example.com.