Priorix: Package Insert and Label Information

PRIORIX- measels, mumps, and rubella vaccine, live
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

For subcutaneous injection only.

2.1 Dose and Schedule

After reconstitution, a single dose of PRIORIX is approximately 0.5 mL.

Administer according to the following schedule:

First dose – 12 through 15 months of age
Second dose – 4 through 6 years of age

If PRIORIX is not administered according to this schedule and 2 doses of measles-, mumps- and rubella-virus vaccine are recommended for an individual, there should be a minimum of 4 weeks between the first and second dose.

PRIORIX may be administered as a second dose to individuals who have received a first dose of another measles, mumps and rubella virus-containing vaccine.

2.2 Preparation

Reconstitute the Lyophilized Antigen Component, Live only with the accompanying Sterile Water Diluent Component to form PRIORIX. The reconstituted vaccine should be a clear peach- to fuchsia pink-colored suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, do not administer the vaccine.

Figure 1
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Figure 2
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Figure 3
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Figure 4
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Figure 1. Hold the prefilled syringe by the barrel and unscrew the syringe cap by twisting it counterclockwise. Align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock.

Figure 2. Cleanse the vial stopper. Transfer the entire contents of the prefilled syringe into the lyophilized antigen component vial.

Figure 3. Shake the vial well until the powder is completely dissolved. Do not invert the vial while shaking.

Figure 4. After reconstitution, withdraw the entire contents of the reconstituted vaccine into the same syringe and after changing the needle, administer subcutaneously.

2.3 Administration

Administer PRIORIX immediately after reconstitution. If not used immediately, store refrigerated between 36° and 46° F (2° and 8°C) and administer within 8 hours. Discard reconstituted vaccine if not used within 8 hours.

3 DOSAGE FORMS AND STRENGTHS

PRIORIX is a suspension for injection supplied as a single-dose vial of lyophilized antigen component to be reconstituted with the accompanying prefilled syringe of sterile water diluent. A single dose after reconstitution is approximately 0.5 mL.

4 CONTRAINDICATIONS

4.1 Severe Allergic Reactions

Do not administer PRIORIX to individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine [see Description (11)].

4.2 Immunosuppression

Due to the risk of disseminated vaccine virus infection, do not administer PRIORIX to individuals with severe humoral or cellular (primary or acquired) immunodeficiency.

4.3 Pregnancy

Do not administer PRIORIX to individuals who are pregnant. Pregnancy should be avoided for 1 month after vaccination [see Use in Specific Populations (8.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Allergic Vaccine Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of PRIORIX.

5.2 Febrile Seizures

There is a risk of febrile seizure following immunization with PRIORIX [see Adverse Reactions (6.1)].

5.3 Thrombocytopenia

Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX [see Adverse Reactions (6.2)].

5.4 Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from fainting.

5.5 Latex

The tip caps of the prefilled syringes of diluent contain natural rubber latex, which may cause allergic reactions.

5.6 Risk of Vaccine Virus Transmission

Live attenuated rubella vaccine virus has been detected in the nose and throat of individuals 7 to 28 days after vaccination with a rubella virus containing vaccine. No documented confirmed cases of transmitted rubella vaccine virus have been reported.1

5.7 Limitation of Vaccine Effectiveness

Vaccination with PRIORIX may not protect all susceptible individuals.

6 ADVERSE REACTIONS

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

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of PRIORIX was evaluated in 6 clinical studies, in which a total of 12,151 participants (6,391 in the United States) received at least 1 dose of PRIORIX: 8,780 children (4,148 in the United States) 12 through 15 months of age; 2,917 children (1,950 in the United States) 4 through 6 years of age; and 454 adults and children (293 in the United States) 7 years of age and older. Across the 6 studies, participants who received PRIORIX are as follows: 51.6% were male; 64.6% were White, 18.4% were Asian, 6.1% were Black, and 10.9% were of other racial groups (including American Indian/Native American, Native Hawaiian/Pacific Islander, Arabic/North African and Other); and 14.3% were of Hispanic/Latino ethnicity. The racial/ethnic distribution of participants who received PRIORIX and M‑M‑R II was similar.

Children 12 through 15 Months of Age Who Received PRIORIX as a First Dose

In a randomized, observer-blind, controlled clinical study (Study 1, NCT01702428) conducted in 5 countries (United States [including Puerto Rico], Estonia, Finland, Mexico and Spain), 5,003 participants 12 through 15 months of age received a first dose of PRIORIX (n = 3,714) or M‑M‑R II (n = 1,289) given concomitantly with HAVRIX (Hepatitis A Vaccine) and VARIVAX (Varicella Virus Vaccine Live, Merck & Co., Inc.); children enrolled in the United States also received PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine, Pfizer Inc.) 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. The median age of participants was 12 months (range: 11 to 16 months). 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 (i.e., neck stiffness with or without photophobia or headache) were collected for 43 days (Table 1). Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review. Data on solicited adverse reactions and unsolicited adverse events were transcribed into the study database during an on-site visit on Day 42 and via telephone contact on Day 180.

Table 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 (Study 1, NCT01702428, Total Vaccinated Cohort)a

Adverse Reaction

PRIORIX

n (%)

M-M-R II

n (%)

Local (within 4 Daysb)

N = 3,555

N = 1,242

Pain

919 (25.9%)

349 (28.1%)

Redness

870 (24.5%)

313 (25.2%)

Swelling

318 (8.9%)

133 (10.7%)

Systemic (within 15 Daysb)

N = 3,566

N = 1,243

Drowsiness

1601 (44.9%)

586 (47.1%)

Irritability

2258 (63.3%)

819 (65.9%)

Loss of appetite

1608 (45.1%)

548 (44.1%)

Systemic (within 43 Daysb)

N = 3,566

N = 1,243

Measles/rubella-like rash

235 (6.6%)

77 (6.2%)

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

1244 (34.9%)

412 (33.1%)

Parotid/ salivary gland swelling

0

0

Febrile convulsions

7 (0.2%)

3 (0.2%)

Signs of meningeal irritationc

3 (0.1%)

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.
a HAVRIX and VARIVAX were administered concomitantly with PRIORIX or M-M-R II; participants in the U.S. also received PREVNAR 13 concomitantly with PRIORIX (n = 1,847) or M-M-R II (n = 654).
b 4 Days, 15 Days, and 43 Days included the day of vaccination and the subsequent 3, 14, and 42 days, respectively.c Neck stiffness with or without photophobia or headache.

Children 12 through 15 Months of Age Who Received a Second Dose of PRIORIX 6 Weeks after the First Dose

In a randomized, observer-blind, controlled clinical study (Study 2, NCT01681992) conducted in six countries (United States [including Puerto Rico], Czech Republic, Finland, Malaysia, Spain and Thailand), 4,516 participants 12 through 15 months of age received a first dose of PRIORIX (n = 2,990) or M‑M‑R II (n = 1,526) followed by a second dose of the same vaccine 6 weeks later. The first dose was given concomitantly with HAVRIX and VARIVAX; children enrolled in the United States (including Puerto Rico) also received PREVNAR 13 concomitantly. In the overall population, 51.7% were male; 68.4% were White, 24.4% were Asian, 3.2% were Black, and 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. The median age of participants was 12 months (range: 11 to 16 months). 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 (i.e., 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. Data on solicited adverse reactions and unsolicited adverse events were transcribed into the study database during on-site visits on Day 42, Day 84, and Day 222. The safety profile of PRIORIX following the second dose was similar to the safety profile following the first dose of PRIORIX.

Children 4 through 6 Years of Age Who Received PRIORIX as a Second Dose of Measles, Mumps, and Rubella Vaccine

In a randomized, observer-blind, controlled clinical study (Study 3, NCT01621802) conducted in 3 countries (United States, South Korea, and Taiwan), 4,007 participants 4 through 6 years of age received PRIORIX (n = 2,917) or M-M-R II (n = 1,090) as a second dose following administration of an initial dose of a combined measles, mumps, and rubella virus-containing vaccine in the second year of life. PRIORIX and M-M-R II were given concomitantly with KINRIX (DTaP-IPV) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] and VARIVAX in a subset of subjects (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, and 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. The median age of participants was 4 years (range: 3 to 6 years). 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 (i.e., neck stiffness with or without photophobia or headache) were collected for 43 days (Table 2). Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review. Data on solicited adverse reactions and unsolicited adverse events were transcribed into the study database during an on‑site visit on Day 42 and via telephone contact on Day 180.

Table 2. Incidence of Solicited Local and Systemic Adverse Reactions after the Second Dose of PRIORIX Compared with M-M-R II Concomitantly Administered with KINRIX and VARIVAX in Children 4 through 6 Years of Age (Study 3, NCT01621802, Total Vaccinated Cohort)

Adverse Reaction

PRIORIX

n (%)

M-M-R II

n (%)

Local (within 4 Daysa)

N = 727

N = 267

Pain

295 (40.6%)

109 (40.8%)

Redness

157 (21.6%)

69 (25.8%)

Swelling

82 (11.3%)

28 (10.5%)

Systemic (within 4 Daysa)

N = 731

N = 268

Drowsiness

199 (27.2%)

72 (26.9%)

Loss of appetite

154 (21.1%)

59 (22.0%)

Systemic (within 43 Daysa)

N = 731

N = 268

Measles/rubella-like rash

14 (1.9%)

5 (1.9%)

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

177 (24.2%)

67 (25.0%)

Parotid/ salivary gland swelling

0

0

Febrile convulsions

0

0

Signs of meningeal irritationb

0

2 (0.7%)

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.
a 4 Days and 43 Days included the day of vaccination and the subsequent 3 and 42 days, respectively.b Neck stiffness with or without photophobia or headache.

Individuals 7 Years of Age and Older Who Received PRIORIX as a Second Dose of Measles, Mumps, and Rubella Vaccine.

In a randomized, observer-blind, controlled clinical study (Study 4, NCT02058563) conducted in 3 countries (United States, Slovakia, and Estonia), 860 participants 7 years of age and older received PRIORIX (n = 426) or M-M-R II (n = 434) as a second dose following previous administration of a combined measles, mumps, and rubella virus-containing vaccine. Participants 7 through 17 years were enrolled if they had received one dose of a combined measles, mumps, and rubella 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 measles, mumps, and rubella 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. The median age of participants was 26 years (range: 7 to 59 years). 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 (Table 3). Unsolicited adverse events that occurred within 43 days following vaccination were recorded using diary cards supplemented by medical review. Data on solicited adverse reactions and unsolicited adverse events were transcribed into the study database during an on-site visit on Day 42 and via telephone contact on Day 180.

Table 3. Incidence of Solicited Local and Systemic Adverse Reactions after PRIORIX as a Second Dose Compared with M-M-R II in Individuals 7 Years of Age and Older (Study 4, NCT02058563, Total Vaccinated Cohort)a

PRIORIX

n (%)

M-M-R II

n (%)

Local (within 4 Daysb)

N = 405

N = 422

Pain

49 (12.1%)

47 (11.1%)

Redness

48 (11.9%)

50 (11.8%)

Swelling

23 (5.7%)

29 (6.9%)

Systemic (within 43 Daysb)

N = 405

N = 422

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

11 (2.7%)

23 (5.5%)

Measles/rubella-like rash

0

2 (0.5%)

Joint pain (arthralgia/arthritis)

8 (2.0%)

4 (0.9%)

Parotid/ salivary gland swelling

1 (0.2%)

0

Signs of meningeal irritationc

1 (0.2%)

1 (0.2%)

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.
a 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.
b 4 Days and 43 Days included the day of vaccination and the subsequent 3 and 42 days, respectively.c Neck stiffness with or without photophobia or headache.
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