COADMINISTRATION

COADMINIS-
TRATION

PRIORIX did not interfere with the immune response of coadministered vaccines1

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In subsets of participants in Study 1, conducted in children 12 through 15 months of age, immune responses to the antigens contained in HAVRIX, VARIVAX, and PREVNAR 13 were measured 42 days after concomitant administration of dose 1 of PRIORIX or M-M-R II.

  • There was no evidence that PRIORIX interfered with the antibody responses to these vaccines relative to the antibody responses when M-M-R II was concomitantly administered

Study design: Study 11

In Study 1, a randomized, observer-blind, controlled study, conducted in the United States (including Puerto Rico), Estonia, Finland, Mexico, and Spain, 5003 participants 12 through 15 months of age (median age, 12 months; range, 11-16 months) received a first dose of PRIORIX (n=3714) or M-M-R II (n=1289) given concomitantly with HAVRIX (Hepatitis A Vaccine) and VARIVAX (Varicella Virus Vaccine Live). Children enrolled in the United States also received PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine) concomitantly.

In the overall population, 51.3% were male, 75.6% were White, 4.8% were Black, 43.5% were Asian, 16.1% were of other racial groups (including American Indian/Native American, Native Hawaiian/Pacific Islander, Arabic/North African and Other), and 18.6% were of Hispanic/Latino ethnicity.

In subsets of participants in Study 1, immune responses to the antigens contained in HAVRIX, VARIVAX, and PREVNAR 13 were measured in sera obtained 42 days after concomitant administration of PRIORIX or M-M-R II.

In subsets of participants in Study 3, conducted in children 4 through 6 years of age, immune responses to the antigens contained in KINRIX and VARIVAX were measured in sera obtained 42 days after concomitant administration of dose 2 of PRIORIX or M-M-R II.

  • There was no evidence that PRIORIX interfered with the antibody responses to these vaccines relative to the antibody responses when M-M-R II was concomitantly administered

Study design: Study 31

In Study 3, a randomized, observer-blind, controlled study conducted in the United States, South Korea, and Taiwan, 4007 participants 4 through 6 years of age (median age, 4 years; range, 3-6 years) received PRIORIX (n=2917) or M-M-R II (n=1090) as a second dose following administration of an initial dose of a combined MMR virus-containing vaccine in the second year of life. PRIORIX and M-M-R II were given concomitantly with KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) and VARIVAX (Varicella Virus Vaccine Live) in a subset of participants (n=802 receiving PRIORIX, n=298 receiving M-M-R II) enrolled in the United States.

In the overall population, 52.5% were male, 42.4% were White, 37.2% were Asian, 8.2% were Black, 12.3% were of other racial groups (including American Indian/Native American, Native Hawaiian/Pacific Islander, Arabic/North African and Other), and 17.2% were of Hispanic/Latino ethnicity.

Prior to vaccination, the percentages of participants with antibody levels above the seroresponse thresholds were 98.0% for measles, 95.7% for mumps, and 98.7% for rubella.

Immune responses to the antigens contained in KINRIX and VARIVAX were measured in sera obtained 42 days after concomitant administration of PRIORIX or M-M-R II.