TY - JOUR
T1 - Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months
T2 - A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
AU - Klein, Nicola P.
AU - Abu-Elyazeed, Remon
AU - Povey, Michael
AU - Parra, Mercedes Macias
AU - Diez-Domingo, Javier
AU - Ahonen, Anitta
AU - Korhonen, Tiina
AU - Tinoco, Juan Carlos
AU - Weiner, Leonard
AU - Marshall, Gary S.
AU - Silas, Peter E.
AU - Sarpong, Kwabena O.
AU - Ramsey, Keith P.
AU - Fling, John A.
AU - Speicher, David
AU - Campos, Maribel
AU - Munjal, Iona
AU - Peltier, Christopher
AU - Vesikari, Timo
AU - Baccarini, Carmen
AU - Caplanusi, Adrian
AU - Gillard, Paul
AU - Carryn, Stephane
AU - Henry, Ouzama
N1 - Funding Information:
Financial support. This work was supported by GlaxoSmithKline Biologicals SA (GSK), which was the funding source and was involved in all stages of study conduct and analysis. GlaxoSmithKline Biologicals SA also took responsibility for all costs associated with the development and publishing of this article.
Funding Information:
Potential conflicts of interest. N. P. K., L. W., J. A. F., M. C., and C. P. report receiving grants from the GSK group of companies. N. P. K. also reports receiving grants from Merck & Co, Pfizer, Inc, Sanofi Pasteur, Novartis (now in the GSK group of companies), Protein Science (now Sanofi Pasteur), and MedImmune. L. W. also reports receiving grants from Merck & Co and Novartis and personal fees from Sanofi Pasteur for consulting services. M. C. also reports receiving a grant from the National Institute of Allergy and Infectious Diseases for clinical study. C. P. also reports receiving grants from Sanofi Pasteur and Regeneron. R. A.-E., M. P., P. G., S. C., and O. H. are employees of the GSK group of companies. R. A.-E., P. G., S. C., and O. H. hold shares in the GSK group of companies as part of their employee remuneration. M. M. P. reports receiving a grant, speaker’s honorarium, and consulting fee from Novartis and Sanofi Pasteur. J. D.-D. reports receiving grants, a speaker’s honorarium, and a consulting fee from the GSK group of companies, MSD, and SPMSD. G. S. M. is a scientific advisor and investigator for the GSK group of companies, Merck & Co, Novartis, Pfizer, Inc, Sanofi Pasteur, and Seqirus and reports receiving speaker’s honoraria from Pfizer, Inc, and Sanofi Pasteur. K. P. R. reports receiving research support from Novartis and research support from the GSK group of companies. I. M. served as a site investigator for the GSK group of companies and received funding as part of her involvement in the trial; she is an employee of Pfizer, Inc. T. V. declares receiving payment for lectures in the past from the GSK group of companies. C. B. and A. C. were employees of the GSK group of companies at the time the study was conducted. All other authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Publisher Copyright:
© The Author(s) 2019
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Immunogenicity
KW - Measles-mumps-rubella vaccine
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85074613343&partnerID=8YFLogxK
U2 - 10.1093/JPIDS/PIZ010
DO - 10.1093/JPIDS/PIZ010
M3 - Article
C2 - 30849175
AN - SCOPUS:85074613343
SN - 2048-7207
VL - 9
SP - 194
EP - 201
JO - Journal of the Pediatric Infectious Diseases Society
JF - Journal of the Pediatric Infectious Diseases Society
IS - 2
ER -