Please use this identifier to cite or link to this item: https://doi.org/10.1186/1471-2334-14-530
Title: A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia
Authors: Lim, F.S 
Koh, M.T
Tan, K.K
Chan, P.C 
Chong, C.Y 
Shung Yehudi, Y.W
Teoh, Y.L
Shafi, F
Hezareh, M
Swinnen, K
Borys, D
Keywords: 10 valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine
antipyretic agent
bacterial vaccine
bacterium antibody
diphtheria pertussis poliomyelitis tetanus Haemophilus influenzae type b hepatitis B vaccine
diphtheria pertussis tetanus Haemophilus influenzae type b vaccine
protein D antibody
Rotavirus vaccine
unclassified drug
bacterial polysaccharide
bacterial protein
bacterium antibody
carrier protein
glpQ protein, Haemophilus influenzae
immunoglobulin D
lipoprotein
Pneumococcus vaccine
vaccine
antibody titer
Article
bacterial immunity
controlled study
coughing
diarrhea
diphtheria
drug safety
female
fever
Haemophilus infection
hepatitis B
human
immunogenicity
infant
irritability
major clinical study
Malaysia
male
multicenter study
pain
parallel design
pertussis
phase 3 clinical trial
pneumococcal infection
poliomyelitis
randomized controlled trial
rhinorrhea
Rotavirus infection
side effect
Singapore
tetanus
upper respiratory tract infection
urticaria
vaccination
blood
clinical trial
immunization
immunology
Pneumococcal Infections
Streptococcus pneumoniae
vaccination
Antibodies, Bacterial
Bacterial Proteins
Carrier Proteins
Female
Humans
Immunization, Secondary
Immunoglobulin D
Infant
Lipoproteins
Malaysia
Male
Pneumococcal Infections
Pneumococcal Vaccines
Polysaccharides, Bacterial
Singapore
Streptococcus pneumoniae
Vaccination
Vaccine Potency
Vaccines, Conjugate
Issue Date: 2014
Citation: Lim, F.S, Koh, M.T, Tan, K.K, Chan, P.C, Chong, C.Y, Shung Yehudi, Y.W, Teoh, Y.L, Shafi, F, Hezareh, M, Swinnen, K, Borys, D (2014). A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infectious Diseases 14 (1) : 530. ScholarBank@NUS Repository. https://doi.org/10.1186/1471-2334-14-530
Rights: Attribution 4.0 International
Abstract: Background: The immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed.Methods: In the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA.Results: Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, ≥93.6% and ≥88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations ≥0.2 μg/mL and OPA titres ≥8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, ≥60.8% and ≥98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations ≥0.2 μg/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was ≤11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study.Conclusions: PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625. © 2014 Lim et al.; licensee BioMed Central Ltd.
Source Title: BMC Infectious Diseases
URI: https://scholarbank.nus.edu.sg/handle/10635/181484
ISSN: 14712334
DOI: 10.1186/1471-2334-14-530
Rights: Attribution 4.0 International
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