IMMUNE RESPONSE DATA

Proven in clinical studies

The effectiveness of PRIORIX is based on a comparison of immune responses relative to M-M-R II1

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  • Study 1: PRIORIX vs M-M-R II, Dose 1 at 12 through 15 months of age

    PRIORIX IMMUNE RESPONSE: STUDY 1
    PRIORIX was demonstrated to be noninferior to M-M-R II after dose 11
    Study 1: Immune responses after the first dose of PRIORIX compared with M-M-R II in children 12 through 15 months of age (ATP population)1

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    ATP cohort included all vaccinated participants who met protocol-defined criteria for immunogenicity analysis.

    PRIORIX or M-M-R II was administered concomitantly with HAVRIX (Hepatitis A Vaccine) and VARIVAX (Varicella Virus Vaccine Live); US participants also received PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine).

    ATP=according-to-protocol; ELU/mL=ELISA units per milliliter; GMC=geometric mean antibody concentration adjusted for country; IU/mL=international units per milliliter; mIU/mL=milli-international units per milliliter; N=number of participants; SRR=seroresponse rate.

    *Seroresponse rate: the percentage of initially seronegative subjects with concentration above seroresponse threshold for each assay. Seroresponse thresholds are 200 mIU/mL, 10 ELU/mL, and 10 IU/mL for anti-measles, anti-mumps, and anti-rubella antibodies, respectively.

    †Noninferiority criterion met for all antigens (lower limit of 2-sided 95% Confidence Interval [CI] for the difference [group receiving PRIORIX minus group receiving M-M-R II] was ≥-5%).

    ‡Noninferiority criterion met for all antigens (lower limit of 2-sided 95% CI for the ratio [group receiving PRIORIX over group receiving M-M-R II] was ≥0.67).

    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, 3.5% 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.

    Antibody responses to measles, mumps, and rubella viruses were measured by ELISAs using sera obtained 42 days following the first dose of either PRIORIX or M-M-R II.

    The noninferiority of the immune response of PRIORIX compared with M-M-R II was demonstrated in terms of seroresponse rates and antibody geometric mean concentrations to measles, mumps, and rubella viruses.

  • Study 2: PRIORIX vs M-M-R II, Dose 2 at 12 through 15 months of age

    Study design: Study 21
    Children 12 through 15 months of age who received a second dose of PRIORIX 6 weeks after the first dose

    In Study 2, a randomized, observer-blind, controlled clinical study conducted in the United States (including Puerto Rico), Czech Republic, Finland, Malaysia, Spain, and Thailand, 4516 participants 12 through 15 months of age (median age, 12 months; range, 11-16 months) received a first dose of PRIORIX (n=2990) or M-M-R II (n=1526) followed by a second dose of the same vaccine 6 weeks later. The first dose was given concomitantly with HAVRIX (Hepatitis A Vaccine) and VARIVAX (Varicella Virus Vaccine Live); children enrolled in the United States (including Puerto Rico) also received PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine) concomitantly.

    In the overall population, 51.7% were male; 68.4% were White, 24.4% were Asian, 3.2% were Black, 4.0% were of other racial groups (including American Indian/Native American, Native Hawaiian/Pacific Islander, Arabic/North African, and Other); and 5.6% were of Hispanic/Latino ethnicity.

    Antibody responses to measles, mumps, and rubella viruses were measured in a subset of participants (n=199-259 PRIORIX; n=212-257 M-M-R II) in sera obtained 42 days following the second dose of either PRIORIX or M-M-R II.

    In a descriptive analysis, the immune response after a second dose was similar between the group receiving PRIORIX and the group receiving M-M-R II in terms of antibody geometric mean concentrations and seroresponse rates for all antigens.

  • Study 3: PRIORIX vs M-M-R II, Dose 2 at 4 through 6 years of age

    PRIORIX IMMUNE RESPONSE: STUDY 3
    PRIORIX was demonstrated to be noninferior to M-M-R II after dose 21
    Study 3: Immune responses to PRIORIX compared with M-M-R II as a second dose in children 4 through 6 years of age (ATP population)1

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    ATP cohort included all vaccinated participants who met protocol-defined criteria for immunogenicity analysis.

    ATP=according-to-protocol; ELU/mL=ELISA units per milliliter; GMC=geometric mean antibody concentration adjusted for prevaccination concentration; IU/mL=international units per milliliter; mIU/mL=milli-international units per milliliter; N=number of participants; SRR=seroresponse rate.

    *Seroresponse rate: the percentage of participants with concentration above seroresponse threshold for each assay. Seroresponse thresholds are 200 mIU/mL, 10 ELU/mL, and 10 IU/mL for anti-measles, anti-mumps, and anti-rubella antibodies, respectively.

    †Noninferiority criterion met for all antigens (lower limit of 2-sided 97.5% Confidence Interval (CI) for the difference [group receiving PRIORIX minus group receiving M-M-R II] was ≥-5%).

    ‡Noninferiority criterion met for all antigens (lower limit of 2-sided 97.5% CI for the ratio [group receiving PRIORIX over group receiving M-M-R II] was ≥0.67).

    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.

    Antibody responses to measles, mumps, and rubella viruses were measured by ELISAs using sera obtained 42 days following either PRIORIX or M-M-R II as a second dose.

    The noninferiority of PRIORIX to M-M-R II when administered with KINRIX and VARIVAX was demonstrated in terms of seroresponse rates and antibody geometric mean concentrations to measles, mumps, and rubella viruses at Day 42.

  • Study 4: PRIORIX vs M-M-R II, Dose 2 at 7 years of age and older

    PRIORIX IMMUNE RESPONSE: STUDY 4
    PRIORIX was demonstrated to be noninferior to M-M-R II after dose 21
    Study 4: Immune responses to PRIORIX as a second dose compared with M-M-R II in participants 7 years of age and older (ATP population)1

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    ATP cohort included all vaccinated participants who met protocol-defined criteria for immunogenicity analysis.

    ATP=according-to-protocol; ELU/mL=ELISA units per milliliter; GMC=geometric mean antibody concentration adjusted for gender, age, country, and prevaccination concentration; IU/mL=international units per milliliter; mIU/mL=milli-international units per milliliter; N=number of participants; SRR=seroresponse rate.

    *Seroresponse rate: the percentage of participants with concentration above seroresponse threshold for each assay. Seroresponse thresholds are 200 mIU/mL, 10 ELU/mL, and 10 IU/mL for anti-measles, anti-mumps, and anti-rubella antibodies, respectively.

    †Noninferiority criterion met for all antigens (lower limit of 2-sided 95% Confidence Interval (CI) for the difference [group receiving PRIORIX minus group receiving M-M-R II] was ≥-5%).

    ‡Noninferiority criterion met for all antigens (lower limit of 2-sided 95% CI for the ratio [group receiving PRIORIX over group receiving M-M-R II] was ≥0.67).

    Study design: Study 41

    In Study 4, a randomized, observer-blind, controlled study, conducted in the United States, Slovakia, and Estonia, 860 participants 7 years of age and older (median age, 26 years; range, 7-59 years) received PRIORIX (n=426) or M-M-R II (n=434) as a second dose following previous administration of a combined MMR virus-containing vaccine. Participants 7 through 17 years of age were enrolled if they had received one dose of a combined MMR virus-containing vaccine on or after their first birthday and participants 18 years of age or older were enrolled if they previously received at least one dose of a combined MMR virus-containing vaccine.

    In the overall population, 46.2% were male; 73.8% were White, 0.2% were Asian, 24.0% were Black, and 1.9% were of other racial groups (including American Indian/Native American, Native Hawaiian/Pacific Islander, Arabic/North African and Other) and 13.3% were of Hispanic/Latino ethnicity.

    Prior to vaccination, the percentages of participants with antibody levels above the seroresponse thresholds were 93.1% for measles, 88.0% for mumps, and 81.9 % for rubella.

    Antibody responses to measles, mumps, and rubella were measured in sera obtained 42 days following the second dose of either PRIORIX or M-M-R II.

    The noninferiority of the immune response after the second dose of PRIORIX compared with M-M-R II was demonstrated in terms of seroresponse rates and antibody geometric mean concentrations to measles, mumps, and rubella antigens.

Clinical studies of PRIORIX compared with M-M-R II included coadministration with other pediatric vaccines1

See Coadministration