PURPOSE: To study safety and immunogenicity of concomitant administration of hepatitis B (HB), Tetanus-diphtheria (Td), and Measles-mumps-rubella (MMR) vaccines in healthy 11-12-year-olds. METHOD: One hundred ninety-seven healthy 11-12-year-olds from the general community were randomized in an unblinded study to concomitant vaccination with Recombivax HB brand of HB vaccine and Td and MMR vaccines or to HB given at a separate time from Td and MMR vaccination. Primary analyses were for induction of protective immunity and safety. Secondary endpoints were mean geometric antibody titers for HB and a boosting effect for Td and MMR. Differences in immunogenicity were analyzed using the one-sided Pearson's Chi-square test. RESULTS: Concomitant vaccination for HB, Td, and MMR had a significantly increased incidence of headache, red eyes, and rash compared with nonconcomitant vaccination. There was no significant difference in incidence of serious adverse events, rates of protective immunity, or in secondary endpoints. CONCLUSIONS:Concomitant HB, Td, and MMR vaccination in 11-12-year-olds is as safe and immunogenic as nonconcomitant vaccination.
RCT Entities:
PURPOSE: To study safety and immunogenicity of concomitant administration of hepatitis B (HB), Tetanus-diphtheria (Td), and Measles-mumps-rubella (MMR) vaccines in healthy 11-12-year-olds. METHOD: One hundred ninety-seven healthy 11-12-year-olds from the general community were randomized in an unblinded study to concomitant vaccination with Recombivax HB brand of HB vaccine and Td and MMR vaccines or to HB given at a separate time from Td and MMR vaccination. Primary analyses were for induction of protective immunity and safety. Secondary endpoints were mean geometric antibody titers for HB and a boosting effect for Td and MMR. Differences in immunogenicity were analyzed using the one-sided Pearson's Chi-square test. RESULTS: Concomitant vaccination for HB, Td, and MMR had a significantly increased incidence of headache, red eyes, and rash compared with nonconcomitant vaccination. There was no significant difference in incidence of serious adverse events, rates of protective immunity, or in secondary endpoints. CONCLUSIONS: Concomitant HB, Td, and MMR vaccination in 11-12-year-olds is as safe and immunogenic as nonconcomitant vaccination.
Authors: Manjiri Pawaskar; Elvira Schmidt; Gary S Marshall; Jaime Fergie; Elizabeth Richardson; Louise Parks Saldutti; Se Li; Monika Neumann; Linnea Koller; Barbara Kuter Journal: Hum Vaccin Immunother Date: 2021-06-15 Impact factor: 3.452