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

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)62-71
Number of pages10
JournalPediatric Infectious Disease Journal
Volume32
Issue number1
DOIs
Publication statusPublished - Jan 2013
Externally publishedYes

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Conjugate Vaccines
Tetanus Toxoid
Safety
Vaccination
Vaccines
Meningococcal Vaccines
Pneumococcal Vaccines
Antibodies
Serogroup
tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine
Haemophilus influenzae glpQ protein
Randomized Controlled Trials
Enzyme-Linked Immunosorbent Assay
Serum

Keywords

  • coadministration
  • conjugate vaccines
  • Neisseria meningitidis
  • Streptococcus pneumoniae
  • toddlers

ASJC Scopus subject areas

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

Cite this

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

In: Pediatric Infectious Disease Journal, Vol. 32, No. 1, 01.2013, p. 62-71.

Research output: Contribution to journalArticle

Ruiz-Palacios, Guillermo M. ; Huang, Li Min ; Lin, Tzou Yien ; Hernandez, Lorena ; Lourdes Guerrero, M. ; Villalobos, Antonio Lavalle ; Van Der Wielen, Marie ; Moreira, Marta ; Fissette, Laurence ; Borys, Dorota ; Miller, Jacqueline M. / 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. In: Pediatric Infectious Disease Journal. 2013 ; Vol. 32, No. 1. pp. 62-71.
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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.",
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T1 - 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

T2 - A randomized trial

AU - Ruiz-Palacios, Guillermo M.

AU - Huang, Li Min

AU - Lin, Tzou Yien

AU - Hernandez, Lorena

AU - Lourdes Guerrero, M.

AU - Villalobos, Antonio Lavalle

AU - Van Der Wielen, Marie

AU - Moreira, Marta

AU - Fissette, Laurence

AU - Borys, Dorota

AU - Miller, Jacqueline M.

PY - 2013/1

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N2 - 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.

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