Publication

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

Lim, F.S
Koh, M.T
Tan, K.K
Chan, P.CChong, C.Y
Shung Yehudi, Y.W
Teoh, Y.L
Shafi, F
Hezareh, M
Swinnen, K
... show 1 more
Citations
Altmetric:
Alternative Title
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.
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
Source Title
BMC Infectious Diseases
Publisher
Series/Report No.
Organizational Units
Organizational Unit
MEDICINE
dept
Organizational Unit
Organizational Unit
PAEDIATRICS
dept
Rights
Attribution 4.0 International
Date
2014
DOI
10.1186/1471-2334-14-530
Type
Article
Additional Links
Related Datasets
Related Publications