Background MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this study, we assessed the immunogenicity and safety of another MMR vaccine (MMR-RIT [Priorix, GlaxoSmithKline]) compared with those of the MMR II in 12- to 15-month-old children who received it as a first dose. Methods In this phase III, observer-blinded, noninferiority, lot-to-lot consistency clinical trial (ClinicalTrials.gov identifier NCT01702428), 5003 healthy children were randomly assigned to receive 1 dose of MMR-RIT (1 of 3 production lots) or MMR II along with other age-recommended routine vaccines. We evaluated the immunogenicity of all vaccines in terms of antibody concentrations (by using an enzyme-linked immunosorbent assay or electrochemiluminescence assay) and/or seroresponse rates 43 days after vaccination. We also assessed the reactogenicity and safety of the vaccines. Results Immunoresponses after vaccination with MMR-RIT were robust and noninferior to those after vaccination with the MMR II. Immunogenicity of the 3 production lots of MMR-RIT was consistent; more than 97% of the children had a seroresponse to MMR components. The coadministered vaccines elicited similar immunoresponses in the MMR-RIT and MMR II groups. Both MMR vaccines resulted in comparable reactogenicity profiles, and no safety concerns were detected. Conclusions If licensed, the MMR-RIT could provide a valid option for the prevention of measles, mumps, and rubella in children in the United States and would reduce potential risks of a vaccine shortage.

No abstract

No abstract

BackgroundThe safety, immunogenicity, and efficacy associated with administration of of aQIV in children 6 months through 5 years of age was investigated.1 Although enhanced immunogenicity in children was demonstrated for MF59-adjuvanted influenza vaccines after first administration, the impact of repeated vaccination on immunogenicity and safety has not been evaluated.MethodsA total of 607 subjects who participated in parent study, now aged 12 months through 6 years, were enrolled the subsequent year and received a single dose of study vaccine. Enrolled subjects received the same type of influenza vaccine administered in the parent study (aQIV or nonadjuvanted comparator). Blood samples were taken for immunogenicity assessment prior to the second year vaccination, and 21 and 180 days after vaccination.ResultsAt baseline, approximately 12 months after vaccination in the parent study, subjects in the aQIV group had significantly greater geometric mean titer (GMT) values against all four homologous strains compared with subjects in the nonadjuvanted vaccine group. After year 2 vaccination, CBER criteria for seroconversion and hemagglutination inhibition (HI) titer ≥1:40 were met for the aQIV group for all four homologous strains tested at Day 22. At both Day 22 and Day 181, subjects who received aQIV had significantly greater GMT values for HI against all four homologous strains compared with those who received nonadjuvanted vaccine. Increased immune response of aQIV vs. nonadjuvanted vaccine was also observed for the selected heterologous strains tested at baseline, Day 22 and Day 181. In terms of safety, transient and generally mild to moderate reactogenicity was more commonly observed in the aQIV group vs. the nonadjuvanted group, but overall safety profiles were similar and comparable to the parent study.ConclusionThis first-year revaccination study in young children confirms enhanced immunogenicity and similar safety profile after repeat aQIV vaccination compared with repeat nonadjuvanted influenza vaccination.Reference1.Vesikari T et al. Lancet Respir Med 2018;6:345–356.Disclosures K. Ramsey, Seqirus: Investigator, Research support. Novartis: Investigator, Research support. E. Heijnen, Seqirus: Employee and Shareholder, Global Employee Share Plan and Salary. B. Leav, Seqirus: Employee and Shareholder, Salary. J. Oberye, Seqirus: Employee and Shareholder, Global Employee Share Plan and Salary. B. Zhang, Seqirus: Employee and Shareholder, Company stock and Salary. T. Vesikari, Seqirus: Consultant, Consulting fee.

Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, safety, and tolerability of Vaqta (hepatitis A vaccine) administered with PedvaxHIB (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Infanrix (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 15-month-old children. Five groups were evaluated: Group 1 received Vaqta/Infanrix PedvaxHIB on Day-1 and Vaqta at Week-24; Group 2 received Infanrix PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; Group 3 received Vaqta/PedvaxHIB on Day-1 and Vaqta Week-24; Group 4 received PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; and Group 5 (safety only) received Vaqta on Day-1 and Vaqta at Week-24. Hepatitis A seropositivity rate (SPR: ≥10 mIU/mL), Hib capsular polyribosylribitol phosphate (PRP) antibody response (>1.0 μg/mL), and geometric mean titers (GMT) to pertussis toxin (PT), pertussis filamentous hemagglutinin antibody (FHA), and pertactin were examined. Non-inferiority statistical criteria required a difference >10% in Hepatitis A SPR, PRP >1.0 μg/mL, and a GMT ratio of >0.67 for pertussis antigens. Injection-site and systemic adverse events (AEs) and daily temperatures were collected. Hepatitis A SPRs were 100% for Groups 1-4, regardless of initial serostatus. Anti-PRP titers were comparable (98.1% - 97.0%) for Groups 1-4. GMT and mean fold-rise were comparable for all 3 pertussis antigen components between concomitant and nonconcomitant groups. Criteria for non-inferiority of immune responses for concomitant vs nonconcomitant administration were met for Hepatitis A, Hib, and pertussis antigens. No statistically significant incidence differences of individual AEs were found between concomitant and nonconcomitant groups. No serious vaccine-related AEs or deaths were reported; no subject discontinued due to an AE. Immune responses to Vaqta, PedvaxHIB, and Infanrix given concomitantly were non-inferior to nonconcomitant responses. Vaqta administered with PedvaxHIB & Infanrix had an acceptable safety profile in 15-month-old children.