Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study
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Elsevier Ltd
Abstract
Background: Invasive meningococcal disease has a high burden in young children, particularly during infancy. We investigated the immunogenicity and safety of a quadrivalent meningococcal conjugated vaccine (MenACWY-TT) co-administered with routine vaccines in healthy infants. Methods: In this phase IIIb study (NCT01340898) conducted in 2 centers in Lebanon and Mexico, 750 infants were randomized (2:1:1) to receive MenACWY-TT according to 3 schedules: 3+1 (at ages 2, 4, 6 and 15–18 months; group ACWY3+1); 1+1 (at 6 and 15–18 months; group ACWY1+1) or single-dose at 15–18 months (group ACWY1). All infants received PHiD-CV and DTPa-IPV/Hib at ages 2, 4, 6, 15–18 months. Immune responses to MenACWY-TT were assessed by rSBA and hSBA at 7 months (groups ACWY3+1, ACWY1+1) and pre- and post-vaccination at 15–18 months of age (all groups). Immune responses to co-administered vaccines, reactogenicity and safety were also evaluated. Results: Immunogenicity of MenACWY-TT at 1 month post-primary vaccination was demonstrated in group ACWY3+1: the lower limit of the 95% confidence interval for the percentage of infants with rSBA titers ≥8 was >80% for each serogroup. At 7 months of age, ≥93.9% of MenACWY-TT-primed infants had rSBA titers ≥8. Post-MenACWY-TT vaccination at age 15–18 months, ≥96.3% of participants in all groups had rSBA titers ≥8, regardless of the number of doses received previously. The percentage of infants with hSBA titers ≥4 were ≥87.2% and ≥89.7% at post-primary and booster/single-dose vaccination, respectively. Immune responses to PHiD-CV and DTPa-IPV/Hib did not seem impacted by co-administration with MenACWY-TT in infancy. The incidence of all adverse events was similar among groups. Serious adverse events were reported for 63/750 children in all groups; none were considered vaccine-related by investigators. Conclusion: Primary vaccination with 3 or 1 dose(s) of MenACWY-TT when co-administered with routine pediatric vaccines in infants is immunogenic and well-tolerated. © 2018
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Booster, Co-administration, Immunogenicity, Infants, Quadrivalent meningococcal conjugate vaccine, Antibodies, bacterial, Diphtheria-tetanus-pertussis vaccine, Drug-related side effects and adverse reactions, Female, Haemophilus vaccines, Healthy volunteers, Humans, Immunization schedule, Infant, Lebanon, Male, Meningitis, meningococcal, Meningococcal vaccines, Mexico, Pneumococcal vaccines, Poliovirus vaccine, inactivated, Vaccines, conjugate, Diphtheria pertussis poliomyelitis tetanus haemophilus influenzae type b vaccine, Infanrix ipv hib, Meningococcus vaccine, Pneumococcus vaccine, Bacterium antibody, Diphtheria pertussis tetanus vaccine, Diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -haemophilus influenzae type b conjugate vaccine, Haemophilus vaccine, Phid-cv vaccine, Poliomyelitis vaccine, Tetravalent meningococcal serogroups a, c, w-135 and y tetanus toxoid conjugate vaccine, Vaccine, Antibody titer, Article, Child, Controlled study, Drowsiness, Drug safety, Drug tolerability, Fever, Human, Loss of appetite, Multicenter study, Normal human, Open study, Pain, Phase 3 clinical trial, Preschool child, Priority journal, Randomized controlled trial, Serum bactericidal antibody assay, Side effect, Single drug dose, Swelling, Adverse drug reaction, Blood, Clinical trial, Epidemic meningitis, Immunization, Immunology, Pathology