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.
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.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Guillermo M
GM
Ruiz-Palacios
Li-Min
LM
Huang
Tzou-Yien
TY
Lin
Lorena
L
Hernandez
M Lourdes
ML
Guerrero
Antonio Lavalle
AL
Villalobos
Marie
M
Van der Wielen
Marta
M
Moreira
Laurence
L
Fissette
Dorota
D
Borys
Jacqueline M
JM
Miller
D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D008800:Mexico; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D013624:Taiwan
D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines; C576777:tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine