Immunogenicity and safety of 11- and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study.
Antibodies, Bacterial
/ blood
Bacterial Proteins
/ genetics
Carrier Proteins
/ genetics
Diphtheria-Tetanus-Pertussis Vaccine
/ administration & dosage
Female
Haemophilus influenzae
Hepatitis B Vaccines
/ administration & dosage
Humans
Immunization, Secondary
Immunogenicity, Vaccine
Immunoglobulin D
/ genetics
Infant
Lipoproteins
/ genetics
Male
Pneumococcal Infections
/ immunology
Pneumococcal Vaccines
/ adverse effects
Poliovirus Vaccine, Inactivated
/ administration & dosage
Serogroup
Streptococcus pneumoniae
Vaccines, Combined
/ administration & dosage
Vaccines, Conjugate
/ adverse effects
Immunogenicity
Infants/children
Non-inferiority
PHiD-CV
Pneumococcal conjugate vaccine
Safety
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
03 01 2019
03 01 2019
Historique:
received:
18
03
2018
revised:
24
06
2018
accepted:
11
07
2018
pubmed:
29
7
2018
medline:
7
6
2019
entrez:
29
7
2018
Statut:
ppublish
Résumé
We assessed 2 investigational 11- and 12-valent vaccines, containing capsular polysaccharides of 10 serotypes as in the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and CRM In this phase II, partially-blind, multicentre study (NCT01204658), healthy infants were randomised (1:1:1:1) to receive 11vPHiD-CV, 12vPHiD-CV, PHiD-CV, or 13-valent CRM 951 children received ≥1 primary dose, 919 a booster dose. Pre-defined immunological non-inferiority criteria were met simultaneously for 9/11 11vPHiD-CV serotypes (all except 23F and 19A) and 10/12 12vPHiD-CV serotypes (all except 19A and 6A); thus, non-inferiority objectives were reached. For each PHiD-CV serotype, percentages of children with antibody concentrations ≥0.2 µg/mL were ≥96.7% post-primary (except 6B [≥75.2%] and 23F [≥81.1%]), and ≥98.1% post-booster vaccination. For each PHiD-CV serotype except serotype 1, ≥81.0% and ≥93.9% of children had opsonophagocytic activity titres ≥8, post-primary and booster vaccination. AEs incidence was similar across all groups. SAEs were reported for 117 children (29 in the 11vPHiD-CV group, 26 in the 12vPHiD-CV group, 38 in the PHiD-CV group and 24 in the PCV13 group); 4 SAEs were considered vaccination-related. No fatal events were recorded. Addition of 19A and 6A CRM
Sections du résumé
BACKGROUND
We assessed 2 investigational 11- and 12-valent vaccines, containing capsular polysaccharides of 10 serotypes as in the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and CRM
METHODS
In this phase II, partially-blind, multicentre study (NCT01204658), healthy infants were randomised (1:1:1:1) to receive 11vPHiD-CV, 12vPHiD-CV, PHiD-CV, or 13-valent CRM
RESULTS
951 children received ≥1 primary dose, 919 a booster dose. Pre-defined immunological non-inferiority criteria were met simultaneously for 9/11 11vPHiD-CV serotypes (all except 23F and 19A) and 10/12 12vPHiD-CV serotypes (all except 19A and 6A); thus, non-inferiority objectives were reached. For each PHiD-CV serotype, percentages of children with antibody concentrations ≥0.2 µg/mL were ≥96.7% post-primary (except 6B [≥75.2%] and 23F [≥81.1%]), and ≥98.1% post-booster vaccination. For each PHiD-CV serotype except serotype 1, ≥81.0% and ≥93.9% of children had opsonophagocytic activity titres ≥8, post-primary and booster vaccination. AEs incidence was similar across all groups. SAEs were reported for 117 children (29 in the 11vPHiD-CV group, 26 in the 12vPHiD-CV group, 38 in the PHiD-CV group and 24 in the PCV13 group); 4 SAEs were considered vaccination-related. No fatal events were recorded.
CONCLUSION
Addition of 19A and 6A CRM
Identifiants
pubmed: 30054160
pii: S0264-410X(18)30989-7
doi: 10.1016/j.vaccine.2018.07.023
pii:
doi:
Substances chimiques
Antibodies, Bacterial
0
Bacterial Proteins
0
Carrier Proteins
0
DTPa-HBV-IPV combined vaccine
0
Diphtheria-Tetanus-Pertussis Vaccine
0
Hepatitis B Vaccines
0
Immunoglobulin D
0
Lipoproteins
0
Pneumococcal Vaccines
0
Poliovirus Vaccine, Inactivated
0
Vaccines, Combined
0
Vaccines, Conjugate
0
glpQ protein, Haemophilus influenzae
EC 3.1.4.46
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
176-186Informations de copyright
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.