1685. A Randomized, Consistency Study Comparing Immunogenicity and Safety of 2 Vaccines Against Measles, Mumps and Rubella (MMR) Administered to Children 12–15 Months of Age
Session: Oral Abstract Session: Vaccines in the Young and Vulnerable
Friday, October 28, 2016: 2:00 PM
Room: 388-390

Background: In the US, a combination vaccine against MMR was first licensed in 1971 and is supplied by one manufacturer (Merck & Co., Inc.). GSK Vaccines is developing an MMR vaccine for US licensure (GSK_MMR). This study evaluated: consistency of 3 lots of GSK_MMR; immunogenic non-inferiority of pooled lots of GSK_MMR to Merck & Co., Inc.’s MMR vaccine (MRK_MMR); and acceptable immune response and safety of GSK_MMR.

Methods: In this phase IIIA, controlled, multi-country, observer-blind study (NCT01702428), healthy children 12–15 months of age were randomized (3:1) to receive 1 of 3 lots of GSK_MMR or MRK_MMR, along with hepatitis A vaccine and varicella vaccine (all children) and pneumococcal 13-valent conjugate vaccine (US children only). Antibodies against MMR antigens were measured by ELISA. Primary objectives: lot consistency in terms of seroresponse rates (SRR; met if 2-sided 95% CI of the difference in SRR is within [-5%; 5%]) and antibody geometric mean concentrations (GMCs; met if 2-sided 95% CI of ratio is within [0.67; 1.5]); non-inferiority of 3 pooled lots of GSK_MMR to MRK_MMR (met if the lower limit [LL] of 2-sided 95% CI of difference in SRR [GSK_MMR − MRK_MMR] is ≥-5% and of GMC ratio [GSK_MMR / MRK_MMR] is ≥0.67); and acceptable immune responses (met if LL of 95% CI of SRR [pooled GSK_MMR lots] is ≥90%). Solicited injection site and general symptoms were recorded for 4 and 43 days post-vaccination, respectively; fever was also analyzed during days 5–12 post-vaccination.

Results: 5003 children were enrolled and received GSK_MMR lot 1 (n=1239); GSK_MMR lot 2 (n=1232); GSK_MMR lot 3 (n=1243) or MRK_MMR (n=1289). At day 42 post-vaccination, all GSK_MMR lots met criteria for consistency, non-inferiority of pooled GSK_MMR lots compared with MRK_MMR was confirmed for all antigens, and acceptable immune responses were demonstrated (Table). Solicited symptoms occurred at a similar frequency in recipients of GSK_MMR and MRK_MMR (pain: 25.9% vs 28.1%, redness: 24.5% vs 25.2% and swelling: 8.9% vs 10.7%, respectively; fever: 19.7% vs 18.2%, grade 3 fever: 1.4% vs 1.1%, respectively, during days 5–12 post-vaccination).

Conclusion: Immune responses to GSK_MMR were non-inferior to MRK_MMR, with a similar safety profile.

Funding: GlaxoSmithKline Biologicals SA

Ouzama Henry, MD, MSc1, Nicola P. Klein, MD, PhD2, Michael Povey, MSc3, Mercedes Macías Parra, MD4, Javier Diez-Domingo, MD, PhD5, Anitta Ahonen, MD6, Remon Abu-Elyazeed, MD, PhD1, Tiina Korhonen, MD6, Juan-Carlos Tinoco, MD7, Leonard Weiner, MD8, Gary S. Marshall, MD9, Peter E. Silas, MD10, Kwabena O. Sarpong, MD, MPH11, Keith P. Ramsey, DO12, John a. Fling, MD13, David Speicher, MD14, Maribel Campos, MD MSc MBA FAAP15, Iona Munjal, MD16, Christopher Peltier, MD17, Timo Vesikari, MD, PhD18, Carmen Baccarini, MD, MSc1, Bruce L. Innis, MD1 and Stephane Carryn, PharmD, PhD3, (1)GSK Vaccines, King of Prussia, PA, (2)Kaiser Permanente Vaccine Study Center, Oakland, CA, (3)GSK Vaccines, Wavre, Belgium, (4)Instituto Nacional de Pediatría, Mexico City, Mexico, (5)Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain, (6)University of Tampere, Tampere, Finland, (7)Hospital General de Durango, Durango, Mexico, (8)SUNY Upstate Medical University, Syracuse, NY, (9)University of Louisville School of Medicine, Louisville, KY, (10)Wee Care Pediatrics, Layton, UT, (11)University of Texas, Galveston, TX, (12)Jordan Ridge Kids & Teens, West Jordan, UT, (13)University of North Texas Health Science Centre, Fort Worth, TX, (14)Rainbow Babies and Children's Hospital, Cleveland, OH, (15)Puerto Rico Clinical and Translational Research Consortium, San Juan, Puerto Rico, (16)Pediatric Infectious Disease, The Children's Hospital at Montefiore, Bronx, NY, (17)Pediatric Associates of Mt. Carmel, Inc., Cincinnati, OH, (18)Vaccine Research Center, University of Tampere, Tampere, Finland

Disclosures:

O. Henry, GSK: Employee and Shareholder , Salary

N. P. Klein, GSK: Grant Investigator , Research grant
Merck & Co: Grant Investigator , Research grant
Pfizer: Grant Investigator , Research grant
Sanofi Pasteur: Grant Investigator , Research grant
Novartis (now GSK): Grant Investigator , Research grant
Protein Science: Grant Investigator , Research grant
MedImmune: Grant Investigator , Research grant

M. Povey, GSK: Employee , Salary

M. Macías Parra, EUR, Novartis: Board Member , Consulting fee , Research grant and Speaker honorarium

J. Diez-Domingo, None

A. Ahonen, None

R. Abu-Elyazeed, GSK: Employee and Shareholder , Salary

T. Korhonen, University of Tampere, Finland: Employee and Investigator , Salary

J. C. Tinoco, None

L. Weiner, GSK: Grant Investigator , Grant recipient

G. S. Marshall, GSK: Investigator and Scientific Advisor , Research grant
Merck: Investigator and Scientific Advisor , Research grant
Novartis: Investigator and Scientific Advisor , Research grant
Pfizer: Investigator and Scientific Advisor , Speaker honorarium
Sanofi Pasteur: Investigator and Scientific Advisor , Research grant
Seqirus: Investigator and Scientific Advisor , Research grant

P. E. Silas, None

K. O. Sarpong, None

K. P. Ramsey, GKS, Novartis: Investigator , Research support

J. A. Fling, GSK: Investigator , Research grant

D. Speicher, None

M. Campos, GSK: Investigator , Research grant

I. Munjal, GSK: Investigator , My employer received funding as part of my involvement as a site PI for the trial

C. Peltier, GSK: Investigator , Research grant

T. Vesikari, GSK: Investigator and Scientific Advisor , Consulting fee , payment for travel expenses from GSK group of companies; research support from the institution (University of Tampere) and Research support

C. Baccarini, GSK: Employee , Salary

B. L. Innis, GSK: Employee and Shareholder , GSK stock and stock options and Salary

S. Carryn, GSK: Employee , Salary

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