Immunogenicity and safety of a booster dose of the 10-valent pneumococcal haemophilus influenzae protein D conjugate vaccine coadministered with the tetravalent meningococcal serogroups A, C, W-135 and y tetanus toxoid conjugate vaccine in toddlers: A randomized trial

Guillermo M. Ruiz-Palacios, Li Min Huang, Tzou Yien Lin, Lorena Hernandez, M. Lourdes Guerrero, Antonio Lavalle Villalobos, Marie Van Der Wielen, Marta Moreira, Laurence Fissette, Dorota Borys, Jacqueline M. Miller

研究成果: 雜誌貢獻文章

13 引文 斯高帕斯(Scopus)

摘要

Background: This open, randomized clinical trial (NCT00758264) evaluated the coadministration of a booster dose of the 10-valent pneumococcal conjugate vaccine (PHiD-CV) and a single dose of the tetravalent meningococcal conjugate vaccine (MenACWY-TT) in Taiwanese and Mexican toddlers. Methods: Healthy toddlers aged 12-23 months (N = 363) were randomized (2:1:1) to receive either both vaccines at first visit, MenACWY-TT at first visit and 1 month later PHiD-CV, or PHiD-CV at first visit and 1 month later MenACWY-TT. Immune responses were measured 1 month after MenACWY-TT vaccination by meningococcal serum bactericidal activity (rSBA) assay and 1 month after PHiD-CV vaccination by pneumococcal 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay. Solicited and unsolicited symptoms were recorded for days 4 and 31 postvaccination, respectively. Serious adverse events were recorded throughout the study. Results: The prespecified criteria for noninferiority of coadministration versus individual administrations were met for all meningococcal serogroups (in terms of percentages of toddlers with rSBA titer 8) and all vaccine pneumococcal serotypes (in terms of antibody geometric mean concentration ratios), except pneumococcal serotype 18C. For each meningococcal serogroup, 97.5% of toddlers across the 3 groups had rSBA titers 128 at 1 month after MenACWY-TT vaccination. For each pneumococcal serotype, at 1 month after PHiD-CV vaccination, 96.0% and 92.9% of toddlers across the 3 groups had antibody concentrations 0.2 μg/mL and opsonophagocytic activity titers 8, respectively. The safety profiles of both vaccines when coadministered were clinically acceptable. Conclusions: This study supports the coadministration of PHiD-CV and MenACWY-TT in toddlers.
原文英語
頁(從 - 到)62-71
頁數10
期刊Pediatric Infectious Disease Journal
32
發行號1
DOIs
出版狀態已發佈 - 一月 2013
對外發佈Yes

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Infectious Diseases
  • Microbiology (medical)

指紋 深入研究「Immunogenicity and safety of a booster dose of the 10-valent pneumococcal haemophilus influenzae protein D conjugate vaccine coadministered with the tetravalent meningococcal serogroups A, C, W-135 and y tetanus toxoid conjugate vaccine in toddlers: A randomized trial」主題。共同形成了獨特的指紋。

  • 引用此