Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine using new measles and rubella working seeds in healthy children in Taiwan and Singapore: A phase II, randomized, double-blind trial
Journal
Human Vaccines and Immunotherapeutics
Journal Volume
9
Journal Issue
6
Pages
1308-1315
Date Issued
2013
Author(s)
Abstract
Aim: This study evaluated the immunogenicity and safety of tetravalent measles-mumps-rubella-varicella (MMRV) vaccine produced with measles and rubella monovalent bulks derived from a newly established working seed virus stock (MMRVnew WS) compared with the combined MMRV vaccine derived from the current seed virus stock, in Taiwanese and Singaporean children (NCT00892775). Results: Non-inferiority of MMRVnew WS to MMRV was achieved for all vaccine antigens. The lower limits of the 95% confidence intervals for group differences (MMRVnew WS group vs. MMRV) for measles (99.4% vs. 100%), mumps (89.7% vs. 90.4%), rubella (99.7% vs. 100%) and varicella (97.6% vs. 92.9%) seroconversion rates were greater than -10%. Mild symptoms including a peak in fever between days 5 and 12, post-dose-1, was observed in both groups. Methods: Healthy children aged 11-22 mo were randomized to receive two doses of either the MMRVnew WS vaccine or the MMRV vaccine. Antibody titers against measles, mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay. The primary objective was to demonstrate non-inferiority of MMRVnew WS to MMRV in terms of post-dose-1 seroconversion rates, defined as a group difference with a lower limit of the 95% confidence interval greater than -10% for each antigen. Parents/guardians recorded symptoms in diary cards for 43 d after each vaccine dose. Conclusion: The immune responses elicited by the MMRVnew WS vaccine were non-inferior to that elicited by the MMRV vaccine for all antigens. Both vaccines exhibited an acceptable safety profile in Taiwanese and Singaporean children. ? 2013 Landes Bioscience.
Subjects
Immunogenicity; MMRV vaccine; Newly established working seed virus stock; Safety; Singapore; Taiwan
SDGs
Other Subjects
chickenpox measles mumps rubella vaccine; acute gastroenteritis; antibody titer; article; bronchiolitis; chickenpox; child; cohort analysis; controlled study; double blind procedure; drug fever; drug safety; enzyme linked immunosorbent assay; ethnic group; febrile convulsion; female; human; immunofluorescence test; immunogenicity; incidence; infant; injection site coloration; male; measles; mucocutaneous lymph node syndrome; mumps; normal human; phase 2 clinical trial; randomized controlled trial; rubella; seizure; seroconversion; Singapore; Singaporean; Taiwan; Taiwanese; tonsillitis; upper respiratory tract infection; virus encephalitis; immunogenicity; MMRV vaccine; newly established working seed virus stock; safety; Singapore; Taiwan; Antibodies, Viral; Chickenpox Vaccine; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Enzyme-Linked Immunosorbent Assay; Female; Fever; Fluorescent Antibody Technique; Healthy Volunteers; Humans; Infant; Male; Measles-Mumps-Rubella Vaccine; Singapore; Taiwan; Vaccination; Vaccines, Combined
Type
journal article