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COADMINISTRATION

PRIORIX did not interfere with the immune response of coadministered vaccines1

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.

INDICATION & IMPORTANT SAFETY INFO

INDICATION FOR PRIORIX

IMPORTANT SAFETY INFORMATION FOR PRIORIX

INDICATION FOR PRIORIX

PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

IMPORTANT SAFETY INFORMATION FOR PRIORIX

  • Contraindications for PRIORIX: Do not administer PRIORIX to individuals with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine. Do not administer PRIORIX to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. These individuals are at risk of disseminated vaccine virus infection. Do not administer PRIORIX to individuals who are pregnant. Pregnancy should be avoided for 1 month after vaccination
  • Appropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of PRIORIX
  • There is a risk of febrile seizures following immunization with PRIORIX
  • Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from fainting
  • The tip caps of the prefilled syringes of diluent contain natural rubber latex, which may cause allergic reactions
  • Vaccination with PRIORIX may not result in protection in all vaccine recipients
  • In clinical trials, the most commonly reported (≥10%) solicited adverse reactions were:
    • Age 12 through 15 months–local: pain (26%) and redness (25%); systemic: irritability (63%), loss of appetite (45%), drowsiness (45%), and fever (35%)
    • Age 4 through 6 years–local: pain (41%), redness (22%) and swelling (11%); systemic: loss of appetite (21%), drowsiness (27%), and fever (24%)
    • Age 7 years and older–local: pain (12%) and redness (12%)
  • Administration of immune globulins and other blood products concurrently with PRIORIX may interfere with the expected immune response to the vaccine
  • If a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 weeks after PRIORIX to avoid false-negative results

Please see full Prescribing Information for PRIORIX.

References

  1. Prescribing Information for PRIORIX.