FOOTER TEXT ONSCREEN
Please see full Prescribing Information at PRIORIX.com.
DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland):
PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.
Contraindications for PRIORIX are: a history of severe allergic reactions (for example, anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine; severe humoral or cellular (primary or acquired) immunodeficiency; and pregnancy. Pregnancy should be avoided for 1 month after vaccination.
Please see additional Important Safety Information at the end of this video and at PRIORIX.com.
Hi, my name is Len Friedland. And I’m the Vice President for Scientific Affairs & Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship-trained in pediatric emergency medicine, and a vaccine research specialist.
In this video, I’ll provide an overview of PRIORIX, including considerations that help make PRIORIX an option for the MMR vaccination your patients need.
We will start by discussing dosing and how PRIORIX aligns with the CDC-recommended routine immunization schedule for measles, mumps, and rubella, followed by a review of immune response and clinical safety data for PRIORIX. Next, we’ll touch on the worldwide MMR experience of GSK and finally, we’ll review how PRIORIX is supplied and ordered.
To begin, we’ll take a look at the dosing and schedule for PRIORIX, which aligns with the CDC-recommended routine immunization schedule for measles, mumps, and rubella vaccine. PRIORIX has the same indication as the M-M-R II vaccine.
PRIORIX is administered by subcutaneous injection only. After reconstitution, a single dose of PRIORIX is approximately 0.5 mL.
The first dose of PRIORIX is administered at 12 through 15 months of age, followed by the second dose, which is given at 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 the second dose.
Here you can see the CDC routine schedule for measles, mumps, and rubella vaccination.
Notes from the CDC regarding catch-up vaccination are shown here. For full vaccination recommendations, consult the CDC Immunization Schedules, available on the CDC website.
PRIORIX offers a seamless scheduling transition from your current MMR vaccine.
PRIORIX may be administered as a first dose and also administered as a second dose to individuals who have received a first dose of another measles, mumps, and rubella virus-containing vaccine.
Now let’s explore the clinical trial data that support the immunogenicity of PRIORIX. The effectiveness of PRIORIX is based on a comparison of immune responses relative to M-M-R II.
We’ll begin by discussing Study 1, which was a randomized, observer-blind, controlled trial conducted in 5 countries, with a study population of 5003 children 12 through 15 months of age.
A first dose of PRIORIX or M-M-R II was given concomitantly with HAVRIX and VARIVAX. Children enrolled in the United States also received PREVNAR 13 concomitantly.
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.
This slide shows the seroresponse rates for PRIORIX and M-M-R II after dose 1 in children 12 through 15 months of age.
On this slide, the geometric mean concentrations (or GMCs) after Dose 1 in children 12 through 15 months of age for PRIORIX and M-M-R II are shown.
The noninferiority of the immune response after the first 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 viruses.
Study 2 was conducted in children 12 through 15 months of age who received a first dose of PRIORIX or MMR II followed by a second dose of the same vaccine 6 weeks later. It was a randomized, observer-blind, controlled trial in 6 countries, with 4516 participants.
In a descriptive analysis of a subset of patients, 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 was a randomized, observer-blind, controlled study conducted in 3 countries in 4007 children who were 4 through 6 years of age.
PRIORIX or M-M-R II was given as a second dose following administration of an initial dose of a combined MMR virus-containing vaccine in the second year of life. In this study, PRIORIX and M-M-R II were given concomitantly with KINRIX and VARIVAX in a subset of participants enrolled in the United States.
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.
Here you see the seroresponse rates for PRIORIX and M-M-R II after dose 2 in children 4 through 6 years of age.
And this slide shows the geometric mean concentrations (or GMCs) from the same study.
The noninferiority of PRIORIX to M-M-R II when administered with KINRIX and VARIVAX was demonstrated in terms of antibody seroresponse rates and geometric mean concentrations to MMR viruses at Day 42.
Finally, Study 4 was a randomized, observer-blind, controlled study conducted in 3 countries that included 860 participants who were 7 years of age and older.
Participants received PRIORIX or M-M-R II as a second dose following previous administration of a combined measles, mumps, and rubella virus-containing vaccine.
Antibody responses to measles, mumps, and rubella viruses were measured in sera obtained 42 days following the second dose of PRIORIX or M-M-R II.
Here, you see the seroresponse rate data for PRIORIX and M-M-R II after dose 2 in participants 7 years of age and older.
And here, you see the geometric mean concentrations (or GMCs) from the same study.
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.
Next, we will discuss the immune responses for the vaccines that were coadministered with PRIORIX or M-M-R II.
In Study 1, PRIORIX or M-M-R II was coadministered with HAVRIX, VARIVAX, and PREVNAR 13 in subsets of children 12 through 15 months of age.
In Study 3, PRIORIX or M-M-R II was coadministered with KINRIX and VARIVAX in subsets of children 4 through 6 years of age.
In both studies, there was no evidence that PRIORIX interfered with the antibody responses to the vaccines relative to the antibody responses when M-M-R II was concomitantly administered.
The safety of PRIORIX was evaluated in 6 clinical trials in which 12,151 participants received at least 1 dose of PRIORIX.
Here are the solicited local and systemic adverse reactions reported in 10% or more of study participants after dose 1 (at 12 through 15 months of age) and dose 2 (at 4 through 6 years of age and 7 years of age and older).
As described previously, Study 1 was a randomized, observer-blind, controlled trial conducted in children 12 through 15 months of age. Participants were given a first dose of PRIORIX or M-M-R II concomitantly with HAVRIX and VARIVAX. Children enrolled in the United States also received PREVNAR 13 concomitantly.
The most common adverse reactions in Study 1—reported in 10% or more participants 12 through 15 months of age—were pain, redness, irritability, loss of appetite, drowsiness, and fever.
As described previously, Study 2 was a randomized, observer-blind, controlled clinical trial that included children 12 through 15 months of age who received a first dose of PRIORIX or M-M-R II followed by a second dose of the same vaccine 6 weeks later.
The safety profile of PRIORIX following the second dose was similar to the safety profile following the first dose.
As discussed previously, Study 3 was a randomized, observer-blind, controlled study that included children 4 through 6 years of age. Participants were given PRIORIX or M-M-R II as a second dose after administration of an initial dose of a combined measles, mumps, and rubella virus-containing vaccine in the second year of life. In a subset of participants, PRIORIX and M-M-R II were given concomitantly with KINRIX and VARIVAX.
In Study 3, the most common adverse reactions—reported in 10% or more of a subset of children who received coadministered vaccines—were pain, redness, swelling, drowsiness, loss of appetite, and fever.
As described previously, Study 4 was a randomized, observer-blind, controlled trial conducted in participants 7 years of age and older who received PRIORIX or M-M-R II as a second dose following previous administration of a combined measles, mumps, and rubella virus-containing vaccine.
In participants 7 years of age and older, pain and redness were the most common adverse reactions, reported in 10% or more individuals.
For more information on the safety of PRIORIX, please see the end of this video and PRIORIX.com.
The MMR vaccine from GSK, licensed as PRIORIX, is available in more than 100 countries, with more than 850 million doses distributed worldwide since 1997.
Note that PRIORIX licensed in the United States contains a higher content of each antigen than PRIORIX licensed in the rest of the world.
Next we will look at how PRIORIX is supplied.
PRIORIX is packaged as 2 components in a box.
Inside the box are 10 single-dose vials of lyophilized antigen component and 10 single-dose prefilled ungraduated syringes of sterile water diluent, packaged without needles.
After reconstitution, each vial contains one dose (approximately 0.5 mL) of PRIORIX.
Now, let’s quickly recap what we’ve discussed.
PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.
PRIORIX has an MMR immunization schedule you know. The dosing schedule for PRIORIX aligns with the CDC-recommended routine immunization schedule for MMR.
PRIORIX offers a seamless scheduling transition from your current MMR vaccine.
PRIORIX may be administered as a first dose, and also administered as a second dose to individuals who received a first dose of another MMR virus-containing vaccine.
The effectiveness of PRIORIX is based on a comparison of immune responses relative to M-M-R II.
The safety profile is based on data from 6 clinical trials.
GSK has MMR vaccine experience worldwide. Licensed as PRIORIX (Measles, Mumps, and Rubella Vaccine, Live), it is available in more than 100 countries, with more than 850 million doses distributed worldwide since 1997.
Note that PRIORIX licensed in the United States contains a higher content of each antigen than PRIORIX licensed in the rest of the world.
Finally, PRIORIX is an MMR vaccine with a syringe prefilled with sterile water diluent.
After watching this video, I hope you have a better understanding of the dosing and scheduling considerations that help make PRIORIX an option for MMR vaccination, as well as the clinical data that support that choice.
You can order PRIORIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.
Now let’s take a look at the additional Important Safety Information for PRIORIX.
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
TEXT ONSCREEN:
For US healthcare professionals only.
Trademarks are properties of their respective owners.
©2022 GSK or licensor.
PRIVID220001 September 2022
Produced in USA.
Please see full Prescribing Information at PRIORIX.com.
