Contemporary Clinical Trials Communications (Dec 2023)
A phase II/III randomised, comparative study evaluating the safety and immunogenicity of Biological E's live, attenuated Measles-Rubella vaccine in 9–12 month old healthy infants
Abstract
Background: Measles is a major cause of childhood mortality and one-third of the world's Measles deaths occur in India. Rubella causes lifelong birth defects (Congenital Rubella Syndrome). Although neither condition has a cure, the MR vaccination can successfully prevent both diseases. The safety of Biological E's live attenuated MR vaccine (BE-MR) was established in 4-5-year-old healthy children. This phase-2/3 study was conducted to assess the safety and immunogenicity of BE-MR in 9–12 month old healthy infants. Overall, 600 subjects were enrolled and equally randomized to receive either BE-MR (n = 300) or the comparator vaccine, SII MR-Vac™ (n = 300). Safety profile of BE-MR vaccine was comparable to SII MR-Vac™ with no severe or serious adverse events (AEs) reported across the study groups. The primary objective of demonstrating non inferiority by BE-MR vaccine compared to SIIL's-MR Vac™ was met. The proportion of subjects with ≥ 2-fold and ≥ 4-fold increase in antibody titre against Measles and Rubella in both the study groups was comparable. Overall, BE-MR vaccine elicited robust and protective immune response as demonstrated by high proportion of sero-protected subjects and a large increase in anti-Measles and anti-Rubella antibodies at day 42 and can be administered safely to infants below one-year of age. This study was prospectively registered with the clinical trial registry of India- CTRI/2016/07/007109.
