PMID- 38058513
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231208
IS  - 2451-8654 (Electronic)
IS  - 2451-8654 (Linking)
VI  - 36
DP  - 2023 Dec
TI  - 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.
PG  - 101232
LID - 10.1016/j.conctc.2023.101232 [doi]
LID - 101232
AB  - 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.
CI  - (c) 2023 The Authors. Published by Elsevier Inc.
FAU - Thuluva, Subhash
AU  - Thuluva S
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Gunneri, SubbaReddy
AU  - Gunneri S
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Turaga, Kishore
AU  - Turaga K
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Mogulla, Rammohan Reddy
AU  - Mogulla RR
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Yerroju, Vijay
AU  - Yerroju V
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Peta, Kalyankumar
AU  - Peta K
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Suneetha, Pothakamuri Venkata
AU  - Suneetha PV
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
FAU - Matur, Ramesh V
AU  - Matur RV
AD  - Biological E Limited, 18/1&3, Azamabad, Hyderabad, 500 020, Telangana, India.
LA  - eng
PT  - Journal Article
DEP - 20231122
PL  - Netherlands
TA  - Contemp Clin Trials Commun
JT  - Contemporary clinical trials communications
JID - 101671157
PMC - PMC10696430
OTO - NOTNLM
OT  - Congenital rubella syndrome
OT  - Immunogenicity
OT  - Measles
OT  - Rubella
OT  - Sero-protection
COIS- The authors declare that they have no known competing financial interests or 
      personal relationships that could have appeared to influence the work reported in 
      this paper. Employees of Biological E Limited do not have any stock options or 
      incentives.
EDAT- 2023/12/07 06:42
MHDA- 2023/12/07 06:43
PMCR- 2023/11/22
CRDT- 2023/12/07 04:06
PHST- 2023/07/28 00:00 [received]
PHST- 2023/11/01 00:00 [revised]
PHST- 2023/11/12 00:00 [accepted]
PHST- 2023/12/07 06:43 [medline]
PHST- 2023/12/07 06:42 [pubmed]
PHST- 2023/12/07 04:06 [entrez]
PHST- 2023/11/22 00:00 [pmc-release]
AID - S2451-8654(23)00178-3 [pii]
AID - 101232 [pii]
AID - 10.1016/j.conctc.2023.101232 [doi]
PST - epublish
SO  - Contemp Clin Trials Commun. 2023 Nov 22;36:101232. doi: 
      10.1016/j.conctc.2023.101232. eCollection 2023 Dec.