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
Journal
Pediatric Infectious Disease Journal
Journal Volume
32
Journal Issue
1
Pages
62-71
Date Issued
2013
Author(s)
Ruiz-Palacios G.M.
Lin T.-Y.
Hernandez L.
Lourdes Guerrero M.
Villalobos A.L.
Van Der Wielen M.
Moreira M.
Fissette L.
Borys D.
Miller J.M.
Abstract
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. ? 2012 Lippincott Williams & Wilkins.
Subjects
coadministration; conjugate vaccines; Neisseria meningitidis; Streptococcus pneumoniae; toddlers
SDGs
Other Subjects
diphtheria pertussis poliomyelitis tetanus Haemophilus influenzae type b hepatitis B vaccine; Meningococcus vaccine; Pneumococcus vaccine; acute otitis media; allergic rhinitis; antibody titer; article; asthma; blood group typing; bronchiolitis; bronchopneumonia; child; controlled study; drug fever; drug safety; enzyme linked immunosorbent assay; female; gastroenteritis; head injury; human; immune response; immunogenicity; infant; injection site pain; irritability; male; meningococcosis; Mexico; open study; phase 3 clinical trial; pneumococcal infection; preschool child; priority journal; randomized controlled trial; serotype; serum bactericidal activity; side effect; single drug dose; Taiwan; vaccination; Antibodies, Bacterial; Female; Humans; Immunization, Secondary; Infant; Male; Meningococcal Vaccines; Mexico; Pneumococcal Vaccines; Taiwan
Type
journal article