Immunogenicity and safety of a novel MMR vaccine (live freeze-dried) containing the Edmonston-Zagreb measles strain the Hoshino mumps strain and the RA 27/3 rubella strain: Results of a randomized comparative active controlled phase III clinical trial.

Wednesday, 5th of April 2017

Hum Vaccin Immunother. 2017 Mar 31:0. doi: 10.1080/21645515.2017.1302629. [Epub ahead of print]

Immunogenicity and safety of a novel MMR vaccine (live freeze-dried) containing the Edmonston-Zagreb measles strain the Hoshino mumps strain and the RA 27/3 rubella strain: Results of a randomized comparative active controlled phase III clinical trial.

Sood A¹ Mitra M² Joshi HA³ Nayak US⁴ Siddaiah P⁵ Babu TR⁶ Mahapatro S⁷ Sanmukhani J⁸ Gupta G⁹ Mittal R¹⁰ Glueck R¹¹.

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Abstract

This phase III clinical trial was conducted to evaluate the immunogenicity and safety of the single-dose and multi-dose formulations of a novel MMR vaccine (live freeze-dried) developed by M/s Cadila Healthcare Limited India (Cadila MMR vaccine) containing the Hoshino mumps strain compared to that of an existing MMR vaccine (live freeze-dried) developed by M/s Serum Institute of India Limited India (Serum MMR vaccine). These two vaccines have similar measles and rubella strains but different mumps strains (Hoshino in Cadila MMR vaccine and L-Zagreb in Serum MMR vaccine). Three hundred and twenty-eight subjects of either sex aged 15-18 months were randomized in a 2:1 ratio to receive either the Cadila or Serum MMR vaccine. Immunogenicity assessments (IgG antibodies against measles mumps and rubella viruses) were done at baseline and 42 d after vaccination. Solicited (local and systemic) and unsolicited adverse events were recorded for up to 42 d following vaccination. The Cadila MMR vaccine was found to be non-inferior to the Serum MMR vaccine in terms of end-of-study proportion of subjects seropositive for anti-measles antibodies (100.0% in both groups) anti-mumps antibodies (94.5% vs. 94.0%) and anti-rubella antibodies (95.5% vs. 91.0%). Both vaccines were well tolerated by all study participants; the most common adverse event reported in both groups was fever followed by rash. The results of this phase III clinical trial show that the novel Cadila MMR vaccine is non-inferior to the Serum MMR vaccine.