SAFETY PROFILE

A demonstrated safety profile in 6 clinical trials1

The safety of PRIORIX was evaluated in 6 clinical trials in which 12,151 participants received at least 1 dose of PRIORIX.1

  • Includes 8780 children 12 through 15 months of age, 2917 children 4 through 6 years of age, and 454 adults and children 7 years of age and older1

In clinical trials of PRIORIX, frequency of solicited and unsolicited adverse reactions was similar to M-M-R II after doses 1 and 2.1

Children holding hands dancing
Children holding hands dancing

Adverse Reactions

  • Most commonly reported solicited adverse reactions

    The most commonly reported (≥10%) solicited adverse reactions in the following age groups in clinical trials were1:

    • 12 through 15 months of age—local: pain (26%) and redness (25%); systemic: irritability (63%), loss of appetite (45%), drowsiness (45%), and fever (35%)
    • 4 through 6 years of age—local: pain (41%), redness (22%), and swelling (11%); systemic: loss of appetite (21%), drowsiness (27%), and fever (24%)
    • 7 years of age and older—local: pain (12%) and redness (12%)
  • Study 1: Adverse reactions after 1 dose in children 12 through 15 months of age

    PRIORIX SAFETY PROFILE: STUDY 1

    Study 1: Incidence of solicited local and systemic adverse reactions after the first dose of PRIORIX compared with M-M-R II in children 12 through 15 months of age (total vaccinated cohort)1,*

    Adverse Reaction PRIORIX % (n) M-M-R II % (n)
    Local (within 4 Days†) N=3555 N=1242
    Pain 25.9% (919) 28.1% (349)
    Redness

    24.5% (870)

     25.2% (313)
    Swelling 8.9% (318) 10.7% (133)
    Systemic (within 15 Days†) N=3566 N=1243
    Irritability  63.3% (2258)
    		 65.9% (819)
    Loss of appetite
    		 45.1% (1608) 44.1% (548)
    Drowsiness

    44.9% (1601)

    		 47.1% (586)
    Systemic (within 43 Days†) N=3566

    N=1243

    Fever (defined as temperature ≥38°C/100.4°F)

    34.9% (1244)

    		 33.1% (412)

    Measles/rubella-like rash

    Measles/ rubella-like rash

    		 6.6% (235) 6.2% (77)
    Febrile convulsions 0.2% (7) 0.2% (3)
    Signs of meningeal irritation‡ 0.1% (3) 0

    Parotid/salivary gland swelling

    Parotid/ salivary gland swelling

    		 0 0

    Total vaccinated cohort for safety included all vaccinated participants for whom safety data were available.

    N=number of participants; n=number of participants presenting with solicited adverse reaction described.

    *HAVRIX (Hepatitis A Vaccine) and VARIVAX (Varicella Virus Vaccine Live) were administered concomitantly with PRIORIX or M-M-R II; participants in the United States also received PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine) concomitantly with PRIORIX (n=1847) or M-M-R II (n=654).

    †4 Days, 15 Days, and 43 Days included the day of vaccination and the subsequent 3, 14, and 42 days, respectively.

    ‡Neck stiffness with or without photophobia or headache.

    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.

    Local solicited adverse reactions were recorded by parents or guardians using standardized diary cards for 4 days.

    Systemic solicited adverse reactions of drowsiness, loss of appetite, and irritability were collected for 15 days, and fever, rash, parotid/salivary gland swelling, febrile convulsions, and signs of meningeal irritation (ie, neck stiffness with or without photophobia or headache) were collected for 43 days.

    Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review.

  • Study 2: Adverse reactions after dose 2 in children 12 through 15 months of age

    Study design: study 21

    Second dose administered 6 weeks after the first dose: PRIORIX compared with M-M-R II in children 12 through 15 months of age

    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.

    Local solicited adverse reactions were recorded by parents or guardians using standardized diary cards for 4 days, and systemic adverse reactions of fever, rash, parotid/salivary gland swelling, febrile convulsions, and signs of meningeal irritation (ie, neck stiffness with or without photophobia or headache) were collected for 43 days.

    Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review.

    The safety profile of PRIORIX following the second dose was similar to the safety profile following the first dose of PRIORIX.

  • Study 3: Adverse reactions after dose 2 in children 4 through 6 years of age

    PRIORIX SAFETY PROFILE: STUDY 3

    Study 3: Incidence of solicited local and systemic adverse reactions after the second dose of PRIORIX compared with M-M-R II in children 4 through 6 years of age (total vaccinated cohort)1,*

    Adverse Reaction PRIORIX % (n) M-M-R II % (n)
    Local (within 4 Days†) N=727 N=267
    Pain 40.6% (295) 40.8% (109)
    Redness 21.6% (157) 25.8% (69)
    Swelling 11.3% (82) 10.5% (28)
    Systemic (within 4 Days†) N=731 N=268
    Drowsiness 27.2% (199) 26.9% (72)
    Loss of appetite
    		 21.1% (154) 22.0% (59)
    Systemic (within 43 Days†) N=731 N=268

    Fever (defined as temperature ≥38°C/100.4°F)

    		 24.2% (177) 25.0% (67)

    Measles/rubella-like rash

    Measles/ rubella-like rash

    		 1.9% (14) 1.9% (5)

    Parotid/salivary gland swelling

    Parotid/ salivary gland swelling

    		 0 0
    Febrile convulsions 0 0
    Signs of meningeal irritation‡ 0 0.7% (2)

    Total vaccinated cohort for safety included all vaccinated participants for whom safety data were available.

    N=number of participants. n=number of participants presenting with solicited adverse reaction described.

    *KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) and VARIVAX (Varicella Virus Vaccine Live) were administered concomitantly with PRIORIX or M-M-R II.

    †4 Days and 43 Days included the day of vaccination and the subsequent 3 and 42 days, respectively.

    ‡Neck stiffness with or without photophobia or headache.

    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.

    In a subset of participants who received concomitantly administered vaccines, data on local solicited adverse reactions were recorded by parents or guardians using standardized diary cards for 4 days.

    Systemic solicited adverse reactions of drowsiness and loss of appetite were collected for 4 days, and fever, rash, parotid/salivary gland swelling, febrile convulsions, and signs of meningeal irritation (ie, neck stiffness with or without photophobia or headache) were collected for 43 days.

    Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review.

  • Study 4: Adverse reactions after dose 2 in participants 7 years of age and older

    PRIORIX SAFETY PROFILE: STUDY 4

    Study 4: Incidence of solicited local and systemic adverse reactions after PRIORIX as a second dose compared with M-M-R II in participants 7 years of age and older (total vaccinated cohort)1,*

    Adverse Reaction PRIORIX % (n) M-M-R II % (n)
    Local (within 4 Days†) N=405 N=422
    Pain 12.1% (49) 11.1% (47)
    Redness 11.9% (48) 11.8% (50)
    Swelling 5.7% (23) 6.9% (29)
    Systemic (within 43 Days†) N=405 N=422

    Fever (defined as temperature ≥38°C/100.4°F)

    		 2.7% (11) 5.5% (23)

    Joint pain (arthralgia/arthritis)

    Joint pain (arthralgia/ arthritis)

    		 2.0% (8) 0.9% (4)

    Parotid/salivary gland swelling

    Parotid/ salivary gland swelling

    		 0.2% (1) 0
    Signs of meningeal irritation‡ 0.2% (1) 0.2% (1)

    Measles/rubella-like rash

    Measles/ rubella-like rash

    		 0
    		 0.5% (2)

    Total vaccinated cohort for safety included all vaccinated participants for whom safety data were available.

    N=number of participants; n=number of participants presenting with solicited adverse reaction described.

    *Participants received a first dose of either M-M-R II, PRIORIX, or a non-U.S. combined measles, mumps, rubella, and varicella virus vaccine.

    †4 Days and 43 Days included the day of vaccination and the subsequent 3 and 42 days, respectively.

    ‡Neck stiffness with or without photophobia or headache.

    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, 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.

    Data on solicited local and systemic adverse reactions were recorded by the participants or their parents or guardians using standardized diary cards for 4 days and 43 days, respectively.

    Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review.