RT Journal Article
T1 Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial The MMR-161 Study Group
A1 Ahonen, Anitta
A1 Berry, Andrea
A1 Chatterjee, Archana
A1 Clifford, Robert
A1 Diaz Perez, Clemente
A1 Diez-Domingo, Javier
A1 Haney, Byron
A1 Harrison, Christopher J.
A1 Kerdpanich, Angkool Phirangkul
A1 Lee, Jimmy K. F.
A1 Leonardi, Michael
A1 Martinon-Torres, Federico
A1 Miranda, Mariano
A1 Perez Porcuna, Xavier Maria
A1 Phongsamart, Wanatpreeya
A1 Huda, Sharifah Engku Alwi
A1 Toh, Teck-Hock
A1 Twiggs, Jerry
A1 Arminana, Ulied Angels
A1 Varman, Meera
A1 Zissman, Edward
A1 Caplanusi, Adrian
A1 Carryn, Stephane
A1 Henry, Ouzama
A1 Povey, Michael
A1 MMR-161 Study Grp, 
K1 MMR vaccine
K1 Measles
K1 Mumps
K1 Rubella
K1 Immunogenicity
K1 Safety
K1 Human serum-albumin
K1 United-states
K1 Mmr vaccine
K1 Public-health
K1 Virus
K1 Outbreak
K1 Neutralization
K1 Immunization
K1 Prevention
K1 Immunity
AB Background: The potency of live viral vaccines decreases over time. We compared the immunogenicity and safety of GSK measles-mumps-rubella vaccine (MMR-RIT) formulations at two different potencies with that of the commercially-available MMR II formulation.Methods: In this phase III observer-blind clinical study (NCT01681992), 4516 healthy children aged 12-15 months were randomized (1:1:1 ratio) to receive one dose of MMR-RIT at the minimum potency used for this study (MMR-RIT-Min) or MMR-RIT at the second lowest potency used for this study (MMRRIT-Med), or control MMR II vaccine. A second dose (MMR-RIT or MMR II) was administered 42 days after the first. The study had 10 co-primary objectives to evaluate MMR-RIT versus MMR II immunogenicity via a hierarchical procedure. Anti-measles and anti-rubella antibodies were measured by ELISA and antimumps antibodies by ELISA and unenhanced plaque reduction neutralization test (PRNT).Results: Each formulation induced immune responses to all vaccine antigens after each MMR dose. While the primary objectives for MMR-RIT-Min were not met, MMR-RIT-Med induced immune responses as measured by ELISA against the three vaccine antigens that met pre-specified non-inferiority criteria. The immune response following MMR-RIT-Med against mumps measured by PRNT failed the non-inferiority criterion for seroresponse rate: the 97.5% confidence interval lower limit (-10.94%) was beyond the pre-defined limit of -10%. Immune responses were comparable among groups post-dose 2. No safety concerns were identified, and MMR-RIT and MMR II vaccines had similar reactogenicity and safety profiles.Conclusions: One dose of MMR-RIT formulation with lower potency (MMR-RIT-Med) induced a non-inferior immune response compared to commercial MMR II vaccine, measured by ELISA in one-year-old children. Non-inferiority was not demonstrated in terms of immune response against mumps virus measured by unenhanced PRNT, although the difference was of uncertain clinical relevance. After the second dose, immune responses were comparable among the MMR-RIT and MMR II groups. (C) 2018 Published by Elsevier Ltd.
PB Elsevier sci ltd
SN 0264-410X
YR 2018
FD 2018-09-11
LK https://hdl.handle.net/10668/26782
UL https://hdl.handle.net/10668/26782
LA en
DS RISalud
RD Apr 18, 2025