INFORMATION FOR HEALTH PROFESSIONALS
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PRIORIX™ is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella).
PRIORIX™ meets the World Health Organisation requirements for manufacture of biological substances and for measles, mumps and rubella vaccines and combined vaccines (live).
Each 0.5 mL dose of the reconstituted vaccine contains not less than 103.0 TCID50 of the Schwarz measles, not less than 103.7 of the RIT 4385 mumps, and not less than 103.0 TCID50 of the Wistar RA 27/3 rubella virus strains.
PRIORIX™ is indicated for the active immunisation against measles, mumps and rubella.
A single 0.5 mL dose of the reconstituted vaccine is recommended.
PRIORIX™ is for subcutaneous injection, although it can also be given by intramuscular injection.
PRIORIX™ should under no circumstances be administered intravenously.
PRIORIX™ is contraindicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine (see also Special precautions and special warnings for use). A history of contact dermatitis to neomycin is not a contraindication.
PRIORIX™ should not be given to subjects with impaired immune responses. These include patients with primary or secondary immunodeficiencies.
However, measles, mumps, rubella combined vaccines can be given to asymptomatic HIV-infected persons without adverse consequences to their illness and may be considered for those who are symptomatic.
It is contraindicated to administer PRIORIX™ to pregnant women. Furthermore, pregnancy should be avoided for three months after vaccination (see Pregnancy and Lactation).
As with other vaccines, the administration of PRIORIX™ should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for vaccination.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles.
Infants below 12 months of age may not respond sufficiently to the measles component of the vaccine, due to the possible persistence of maternal measles antibodies. This should not preclude the use of the vaccine in younger infants (<12 months) since vaccination may be indicated in some situations such as high-risk areas. In these circumstances revaccination at or after 12 months of age should be considered.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Vaccines produced in chick embryo tissue cultures have been shown not to contain egg proteins in sufficient amounts to elicit hypersensitivity reactions. Persons having egg allergies, that are not anaphylactic in nature, can be considered for vaccination. (See Contraindications)
PRIORIX™ should be given with caution to persons with a history or family history of allergic diseases or those with a history or family history of convulsions.
Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of the rubella virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day. However there is no evidence of transmission of this excreted vaccine virus to susceptible contacts.
A limited number of subjects received PRIORIX™ intramuscularly. An adequate immune response was obtained for all three components.
PRIORIX™ should under no circumstances be administered intravenously.
If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that live measles (and possibly mumps) vaccine may cause a temporary depression of tuberculin skin sensitivity. This anergy may last for 4-6 weeks and tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
Studies have shown that PRIORIX™ can be administered at the same time as the live attenuated varicella vaccine (Varilrix™) if separate injection sites are used.
Although data on the concomitant administration of PRIORIX™ and other vaccines are not yet available, it is generally accepted that measles mumps and rubella combined vaccine may be given at the same time as the oral polio vaccine (OPV) or inactivated polio vaccine (IPV), the injectable trivalent diphtheria, tetanus and pertussis vaccines (DTPw/DTPa) and Haemophilus influenzae type b (Hib) if separate injection sites are used.
If PRIORIX™ cannot be given at the same time as other live attenuated vaccines, an interval of at least one month should be left between both vaccinations.
In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired mumps, measles and rubella antibodies.
PRIORIX™ may be given as a booster dose in subjects who have previously been vaccinated with another measles mumps and rubella combined vaccine.
It is contraindicated to administer PRIORIX™ to pregnant women. Furthermore, pregnancy should be avoided for three months after vaccination.
There is no human data regarding use in breastfeeding women. Persons can be vaccinated where the benefit outweighs the risk.
Not applicable.
Frequencies are reported as:
Very common: ≥ 10%
Common: ≥ 1% and < 10%
Uncommon: ≥ 0.1% and < 1%
Rare: ≥ 0.01% and < 0.1%
Very rare: < 0.01%
In controlled clinical studies, signs and symptoms were actively monitored on more than 10,000 vaccinees during a 42-day follow-up period. The vaccinees were also requested to report any clinical events during the study period. The following adverse reactions were reported by the vaccinees.
Application site:
Very common: local redness
Common: local pain and swelling
Body as a whole:
Common: fever (rectal >39.5°C, axillary/oral ≥ 39.0°C)
Uncommon: crying abnormal
Central and peripheral nervous system:
Uncommon: febrile convulsions
Endocrine:
Uncommon: parotid swelling
Gastro-intestinal system:
Uncommon: diarrhoea, vomiting, anorexia
Psychiatric:
Common: nervousness
Uncommon: somnolence, insomnia
Resistance mechanism:
Uncommon: other viral infection, otitis media
Respiratory system:
Uncommon: pharyngitis, upper respiratory tract infection, rhinitis, bronchitis, coughing
Skin and appendages:
Common: rash
White cell and reticuloendothelial system:
Uncommon: lymphadenopathy
During post-marketing surveillance, the following reactions have been reported additionally in temporal association with PRIORIX™ vaccination:
Body as a whole:
Very rare: arthralgia, arthritis, allergic reactions, including anaphylactic reactions
Central and peripheral nervous system:
Very rare: meningitis
Platelet, bleeding and clotting:
Very rare: thrombocytopenia, thrombocytopenic purpura
Skin and appendages:
Very rare: erythema multiforme
In rare cases a mumps-like condition with an abbreviated incubation period
cannot be ruled out. In isolated cases transient, painful swelling of the
testicles has been reported after combined mumps, measles, rubella vaccination.
Accidental intravascular administration may give rise to severe reactions or even shock. Immediate measures depend on the severity of the reaction (see Special warnings and special precautions for use).
In the comparative studies, a statistically significant lower instance of local pain, redness and swelling was reported with PRIORIX™ compared with the comparator. The instance of other adverse reactions listed above were similar in both vaccines.
Not applicable.
In clinical studies PRIORIX™ has been demonstrated to be highly immunogenic.
Antibodies against measles were detected in 98.0%, against mumps in 96.1% and
against rubella in 99.3% of previously seronegative vaccinees.
In comparative studies, antibodies against measles, mumps and rubella were detected in 98.7, 95.5% and 99.5% of previously seronegative vaccinees who received PRIORIX™ compared to 96.9%, 96.9% and 99.5% in the group receiving a commercially available measles mumps and rubella combined vaccine.
Subjects followed up to 12 months following vaccination all remained seropositive for anti-measles and anti-rubella antibodies. 88.4% were still seropositive at month 12 for anti-mumps antibody. This percentage is in line with what was observed for the commercially available measles, mumps and rubella combined vaccine(87%).
Evaluation of pharmacokinetic properties is not required for vaccines.
Not applicable.
Lactose, amino acids supplement, mannitol, sorbitol, neomycin sulphate, and water for injections.
PRIORIX™ should not be mixed with other vaccines in the same syringe.
Shelf life
The expiry date of the vaccine is indicated on the label and packaging.
The shelf life is two years when the vaccine is stored according recommendations
(see Special precautions for storage)
PRIORIX™ should be stored in a refrigerator between +2°C and +8°C.
During transport, recommended conditions of storage should be respected, particularly in hot climates.
PRIORIX™ is presented as a whitish to slightly pink pellet in a glass vial. The sterile diluent is clear and colourless and presented in a glass prefilled syringe or ampoule. Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.
Vials/prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine.
The vaccine must be reconstituted by adding the entire contents of the supplied container of diluent to the vial containing the pellet. After the addition of the diluent to the pellet, the mixture should be well shaken until the pellet is completely dissolved in the diluent.
Inject the entire content of the vial.
After reconstitution, the vaccine should be injected as soon as possible and not later than 8 hours after reconstitution.
Prescription Medicine
PRIORIX™ vaccine: monodose glass vials in packs of 1.
Diluent: glass ampoules or prefilled syringes, 0.5mL in packs of 1.
GlaxoSmithKline NZ Limited
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
ph (09) 367 2900
fax (09) 367 2506
24 July 2006