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Priorix Tetra

Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe

Manufacturer
GlaxoSmithKline UK
Label last updated
02 Jan 2026
Source
Official SmPC ↗

Combined measles, mumps, rubella and chickenpox vaccine, given from 11 months. Two doses. Contains four live weakened viruses grown on chick embryo cells and on human foetal lung cells.

68 findings, each with the section of the label it comes from.

Ingredients and materials

  • Measles virus Schwarz strain, live and attenuated, not less than 10^3.0 CCID50 per 0.5 ml doses.2
  • Mumps virus RIT 4385 strain, derived from the Jeryl Lynn strain, live and attenuated, not less than 10^4.4 CCID50s.2
  • Rubella virus Wistar RA 27/3 strain, live and attenuated, not less than 10^3.0 CCID50s.2
  • Varicella (chickenpox) virus OKA strain, live and attenuated, not less than 10^3.3 plaque forming unitss.2
  • Measles and mumps are produced on chick embryo cells; rubella and varicella are produced on human diploid MRC-5 cells - a cell line originally derived from human foetal lung tissues.2
  • Contains a trace amount of neomycin; hypersensitivity to neomycin is a contraindication, though a history of contact dermatitis to neomycin is nots.2, 4.3
  • Powder excipients: amino acids containing phenylalanine, lactose anhydrous, mannitol (E421), sorbitol (E420), Medium 199 containing phenylalanine, para-aminobenzoic acid, sodium and potassiums.6.1
  • Solvent: water for injectionss.6.1
  • Contains 14 mg sorbitol per dose, 6.5 nanograms of para-aminobenzoic acid and 583 micrograms of phenylalanine, the last of which may be harmful in phenylketonuria (PKU)s.2, 4.4
  • Para-aminobenzoic acid may cause allergic reactions, possibly delayed, and exceptionally bronchospasms.4.4
  • Declared essentially sodium-free and potassium-free, less than 1 mmol of each per doses.4.4

Manufacture, storage and handling

  • Shelf life 18 monthss.6.3
  • Store and transport refrigerated at 2C to 8C, do not freeze, store in the original packaging to protect from lights.6.4
  • After reconstitution the vaccine should be given promptly or kept at 2C to 8C, and must be discarded if not used within 24 hourss.6.3
  • Reconstituted by adding the whole syringe of solvent to the powder vial and shaking until completely dissolved; a new needle must be used to administers.6.6
  • The reconstituted vaccine may range in colour from clear peach to fuchsia pink because of minor pH variation, and may contain translucent product-related particulates; this is normals.6.6
  • If the Luer Lock Adaptor comes off during syringe assembly, a new vaccine dose with a new syringe and vial should be useds.6.6
  • Subcutaneous or intramuscular injection into the deltoid or the higher anterolateral thigh; preferably subcutaneous in people with thrombocytopenia or a coagulation disorders.4.2
  • Must under no circumstances be administered intravascularly or intradermallys.4.4
  • Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection because they can inactivate the attenuated virusess.4.4
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2

Safety findings

  • Licensed from 11 months of age, with use in infants of 9 to 10 months considered only under special circumstances such as an epidemiological situation requiring its.4.1, 4.2
  • Two doses, with the interval preferably 6 weeks to 3 months and never less than 4 weekss.4.2
  • Contraindicated in pregnancy, and pregnancy should be avoided for 1 month after vaccinations.4.3, 4.6
  • Contraindicated in current immunosuppressive therapy including high doses of corticosteroids, but not in people receiving topical or low-dose parenteral corticosteroidss.4.3
  • Contraindicated in severe humoral or cellular immunodeficiency, whether primary or acquired, including severe combined immunodeficiency, agammaglobulinemia, AIDS or symptomatic HIV infection, or an age-specific CD4+ T-lymphocyte percentage below 25 per cent in children under 12 months, below 20 per cent in 12 to 35 months, and below 15 per cent in 36 to 59 monthss.4.3
  • Contraindicated in hypersensitivity to the active substances, excipients or neomycin, or after a previous reaction to a measles, mumps, rubella or varicella vaccines.4.3
  • Vaccination should be postponed during acute severe febrile illness; a minor infection such as a cold is not a reason to defers.4.3
  • There was an increased risk of fever and febrile convulsions 5 to 12 days after the first dose of this combined vaccine, compared with giving MMR and varicella vaccines at the same time but separatelys.4.4
  • In a retrospective database analysis of 82,656 children given the combined vaccine, 149,259 given MMR and 39,203 given separate MMR and varicella vaccines, febrile convulsion incidences in the 5 to 12 day risk period were 2.18 or 6.19 per 10,000 for the combined vaccine against 0.49 or 2.55 per 10,000 for controls, depending on the case definition useds.4.8
  • This suggests one additional febrile convulsion per 5,882 or per 2,747 subjects vaccinated with the combined vaccine, with attributable risks of 1.70 (confidence interval -1.86 to 3.46) and 3.64 (confidence interval -6.11 to 8.30) per 10,000 - both intervals cross zeros.4.8
  • Febrile convulsions are listed as a rare adverse reaction, and vaccination of people with a personal or family history of convulsions including febrile convulsions should be considered with caution, with separate MMR and varicella vaccines considered for the first dose instead; vaccinees should be monitored for fever during the risk periods.4.4, 4.8
  • Fever rates are usually high after the first dose of measles-containing vaccines, with the combined vaccine giving about 1.5 times the fever rate of separate MMR and varicella vaccines; there was no indication of increased fever risk after the second doses.4.4, 4.8
  • Salicylates should be avoided for 6 weeks after each vaccination because Reye's syndrome has been reported following salicylates during natural varicella infections.4.4
  • Individuals who have experienced anaphylaxis after eating egg should be vaccinated with extreme caution with adequate treatment for anaphylaxis on hand, because the measles and mumps components are produced in chick embryo cell culture and may contain traces of egg proteins.4.4
  • Immunocompromised patients without a contraindication may not respond as well as immunocompetent people and may still acquire measles, mumps, rubella or varicella on contact despite vaccination, so they should be monitored carefully for signs of these diseasess.4.4
  • Transmission of measles, mumps and rubella viruses from vaccinees to susceptible contacts has never been documented, although pharyngeal excretion of rubella virus is known to occur about 7 to 28 days after vaccination, peaking around day 11s.4.4
  • Transmission of the Oka varicella vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with a rash, and transmission from a vaccinee who does not develop a rash 'cannot be excluded's.4.4
  • Vaccine recipients, even those who do not develop a varicella-like rash, should try to avoid close association with high-risk individuals susceptible to varicella for up to 6 weeks after vaccination. This includes immunocompromised individuals, pregnant women without a documented history of chickenpox or laboratory evidence of prior infection, and newborns of such motherss.4.4
  • Cases of worsening and of recurrence of thrombocytopenia have been reported after live measles, mumps and rubella vaccines in people who had thrombocytopenia after the first dose; the risk-benefit should be evaluated carefully and these patients vaccinated with caution, preferably subcutaneouslys.4.4
  • As with any vaccine, a protective immune response may not be elicited in all vaccinees, and breakthrough varicella has been shown to occur in people who previously received this vaccine; these cases are usually mild with fewer lesions and less fever than in unvaccinated peoples.4.4
  • Very few reports exist of disseminated varicella with internal organ involvement after vaccination with the Oka varicella vaccine strain, mainly in immunocompromised subjectss.4.4
  • Encephalitis has been reported during post-marketing use of live attenuated measles, mumps, rubella and varicella vaccines, with fatal outcomes in a few cases especially in immunocompromised patients; vaccinees or parents should seek prompt medical attention for symptoms such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headaches.4.4, 4.8
  • Post-marketing reports also include meningitis, herpes zoster, measles-like syndrome, mumps-like syndrome including orchitis, epididymitis and parotitis, thrombocytopenia and thrombocytopenic purpura, allergic reactions including anaphylactic and anaphylactoid reactions, cerebellitis, cerebrovascular accident, Guillain-Barre syndrome, transverse myelitis, peripheral neuritis, vasculitis, erythema multiforme, varicella-like rash, arthralgia and arthritiss.4.8
  • For herpes zoster and encephalitis the label notes these are also consequences of wild-type varicella infection and there is no indication of an increased risk after vaccination compared with wild-type diseases.4.8
  • Pregnancy: in a review of more than 3,500 susceptible women unknowingly in early pregnancy when vaccinated with a rubella-containing vaccine, no cases of congenital rubella syndrome were reported, but subsequent post-marketing surveillance identified congenital rubella syndrome associated with the Wistar RA 27/3 rubella vaccine strain after inadvertent vaccination in pregnancys.4.6
  • Foetal damage has not been documented when measles, mumps or varicella vaccines have been given to pregnant womens.4.6
  • Breastfeeding: adequate human data on use during lactation are not availables.4.6
  • Fertility: the vaccine has not been evaluated in fertility studiess.4.6
  • Tuberculin testing should be done before or at the same time as vaccination, because MMR vaccines may cause a temporary depression of tuberculin skin sensitivity lasting up to 6 weeks, giving false negative resultss.4.5
  • In people who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for at least 3 months because of the likelihood of vaccine failure from passively acquired antibodiess.4.5
  • Because of an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when the MenB vaccine is given at the same time, separate vaccinations can be considered where possibles.4.5
  • There are currently insufficient data to support use with any other vacciness.4.5
  • Overdose: no case has been reporteds.4.9

Evidence and claims

  • Efficacy against varicella was evaluated in a large randomised multicountry trial, with children aged 12 to 22 months given two doses of this vaccine 6 weeks apart, or one dose of the single varicella vaccines.5.1
  • Against confirmed varicella of any severity, two doses gave 94.9 per cent at year 2, 95.0 per cent at year 6 and 95.4 per cent at year 10; against moderate or severe varicella, 99.5, 99.0 and 99.1 per cents.5.1
  • One dose of the single varicella vaccine gave only 65.4 per cent at year 2, 67.0 per cent at year 6 and 67.2 per cent at year 10 against any severity, which is the basis for using two dosess.5.1
  • Effectiveness during varicella outbreaks in German day care centres was 91 per cent against any disease and 94 per cent against moderate disease for two doses of the combined vaccines.5.1
  • Seroconversion rates after two doses in about 2,000 children were 99.1 per cent for measles, 98.8 per cent by ELISA and 99.4 per cent by neutralisation for mumps, 99.9 per cent for rubella and 99.8 per cent by one assay and 99.2 per cent by another for varicellas.5.1
  • The immune response is assessed by antibody levels, described as 'widely accepted as surrogate markers for immune protection's.5.1
  • No clinical studies with this combined vaccine have been conducted in subjects over 6 years of age; the safety profile in older subjects is extrapolated from the company's separate MMR vaccine and single varicella vaccines.4.8
  • The safety profile is based on clinical trials giving more than 6,700 doses to more than 4,000 children aged 9 to 27 months, with events recorded for up to 42 days after vaccinations.4.8
  • Preclinical: a repeated dose toxicity study in animals did not reveal any local or systemic toxicity of the vaccines.5.3

Document and licensing

  • Marketing authorisation holder: SmithKline Beecham Ltd, London, trading as GlaxoSmithKline UKs.7
  • First authorised 10 August 2007, last renewal 26 July 2011s.9
  • Text last revised 12 December 2025s.10
  • The febrile convulsion risk is given with absolute incidence rates, attributable risk and confidence intervals, including intervals that cross zeros.4.8
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

After reconstitution, 1 dose (0.5 ml) contains:
 Measles virus^1 Schwarz strain (live, attenuated)
 not less than 10^3.0 CCID50^3
 Mumps virus^1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated)
 not less than 10^4.4 CCID50^3
 Rubella virus^2 Wistar RA 27/3 strain (live, attenuated)
 not less than 10^3.0 CCID50^3
 Varicella virus^2 OKA strain (live, attenuated)
 not less than 10^3.3 PFU^4
 ^1 produced on chick embryo cells
 ^2 produced on human diploid (MRC-5) cells
 ^3 Cell culture infective dose 50%
 ^4 Plaque forming units
 This vaccine contains a trace amount of neomycin. See section 4.3.
 Excipients with known effect 
 The vaccine contains 14 mg of sorbitol per dose.
 The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose and 583 micrograms of phenylalanine per dose (see section 4.4).
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • attenuated - Weakened on purpose so the organism cannot cause the disease in a healthy person.
  • neomycin - An antibiotic used during manufacture to stop bacteria growing. Traces may remain, which is why a neomycin allergy is a contraindication.
  • sorbitol - A sugar alcohol used as a stabiliser and to give the liquid bulk. Also found in sugar-free food.
  • para-aminobenzoic acid - A vitamin-like nutrient, sometimes called PABA, used to grow the cells.
  • phenylalanine - An amino acid. People with the inherited condition phenylketonuria (PKU) have to limit it, which is why it is declared.

Other ingredients (excipients)

Section 6.1 source ↗

  • Powder:
  • Amino acids (containing phenylalanine)The building blocks of protein, present here as nutrients for the cells grown during manufacture.
  • Lactose anhydrousMilk sugar, used as a stabiliser and bulking agent.
  • Mannitol (E 421)A sugar alcohol used as a stabiliser and bulking agent, so the dried powder forms a proper cake.
  • Sorbitol (E 420)A sugar alcohol used as a stabiliser and to give the liquid bulk. Also found in sugar-free food.
  • Medium 199 (containing phenylalanine, para-aminobenzoic acid, sodium and potassium)A standard laboratory nutrient mixture (salts, vitamins, amino acids, sugars) that cells are grown in. Its residues are diluted out almost entirely.
  • Solvent:
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
Audit trail: every flagged sentence in the document (56)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.3 Contraindications

  1. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.

    Section 4.3 Contraindications source ↗

    In plain English

    • hypersensitivity - An allergic-type reaction, from a mild rash up to a severe reaction.

    Trace residues and process chemicals matched: neomycin

  2. A history of contact dermatitis to neomycin is not a contraindication.

    Section 4.3 Contraindications source ↗

    Trace residues and process chemicals matched: neomycin

  3. For egg allergy, see section 4.4.

    Section 4.3 Contraindications source ↗

    Animal, human or cell-line derived material matched: egg

  4. Priorix-Tetra is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).

    Section 4.3 Contraindications source ↗

    In plain English

    • contraindicated - A situation where the medicine should not be given at all.

    Not recommended, contraindicated or restricted matched: contraindicated

  5. Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).

    Section 4.3 Contraindications source ↗

    Not recommended, contraindicated or restricted matched: should be avoided

4.4 Special warnings and precautions for use

  1. 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.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • attenuated - Weakened on purpose so the virus or bacterium can no longer cause the disease in a healthy person.

    Genetic engineering, vectors and GMOs matched: attenuated

  2. The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein.

    Section 4.4 Special warnings and precautions for use source ↗

    Animal, human or cell-line derived material matched: egg

  3. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. generalised urticaria, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after vaccination, although these types of reactions have been shown to be very rare.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • hypersensitivity - An allergic-type reaction, from a mild rash up to a severe reaction.
    • very rare - In the label's frequency scale, this means it happened in up to 1 in 10,000 people. Often these are reports sent in after a vaccine is in use rather than findings from a formal study.

    Animal, human or cell-line derived materialRare or very rare serious events matched: egg, very rare

  4. Individuals who have experienced anaphylaxis after egg ingestion should be vaccinated with extreme caution, with adequate treatment for anaphylaxis on hand should such a reaction occur.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • anaphylaxis - A severe, sudden allergic reaction that can make breathing difficult and needs urgent medical treatment.

    Animal, human or cell-line derived material matched: egg

  5. Salicylates should be avoided for 6 weeks after each vaccination with Priorix-Tetra as Reye's Syndrome has been reported following the use of salicylates during natural varicella infection.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • reye - Reye's syndrome: a rare and serious illness affecting the brain and liver that can follow a viral infection in children given aspirin-type medicines.

    Immune system, shedding and transmissionRare or very rare serious eventsNot recommended, contraindicated or restricted matched: reye, should be avoided

  6. Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles, mumps, rubella or varicella in case of contact, despite appropriate vaccine administration.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

  7. Transmission of measles, mumps and rubella viruses from vaccinees to susceptible contacts has never been documented, although pharyngeal excretion of the rubella virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11^th day.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • transmission - Passing something from one person to another.

    Immune system, shedding and transmission matched: transmission

  8. Transmission of the Oka varicella vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with rash.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • transmission - Passing something from one person to another.

    Immune system, shedding and transmission matched: transmission

  9. Transmission of the Oka varicella vaccine virus from a vaccinee who does not develop a rash to seronegative contacts cannot be excluded.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • transmission - Passing something from one person to another.

    Immune system, shedding and transmission matched: transmission

  10. In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighted against the risk of acquiring and transmitting wild-type varicella virus.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • transmission - Passing something from one person to another.

    Immune system, shedding and transmission matched: transmission

  11. • Immunocompromised individuals (see sections 4.3 and 4.4)

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

  12. Cases of worsening of thrombocytopenia and cases of recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • thrombocytopenia - A low platelet count, which makes bruising and bleeding easier.

    Genetic engineering, vectors and GMOs matched: live

  13. As with any vaccine, a protective immune response may not be elicited in all vaccinees.

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  14. Very few reports exist on disseminated varicella with internal organ involvement following vaccination with Oka varicella vaccine strain mainly in immunocompromised subjects.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

  15. Encephalitis has been reported during post-marketing use of live attenuated measles, mumps, rubella and varicella vaccines.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.
    • post-marketing - After the product went on the market and was given to the public, as opposed to during the original clinical trials.
    • encephalitis - Inflammation of the brain.

    Genetic engineering, vectors and GMOs matched: attenuated

  16. In a few cases fatal outcomes have been observed, especially in patients who were immunocompromised (see section 4.3).

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmissionRare or very rare serious events matched: fatal, immunocompromised

4.5 Interaction with other medicinal products and other forms of interaction

  1. There are currently insufficient data to support the use of Priorix-Tetra with any other vaccines.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • insufficient - Not enough to draw a conclusion from.

    Limited, insufficient or inconclusive matched: insufficient

  2. 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 antibodies.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Animal, human or cell-line derived material matched: blood

4.6 Fertility, pregnancy and lactation

  1. Foetal damage has not been documented when measles, mumps or varicella vaccines have been given to pregnant women.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Animal, human or cell-line derived material matched: foetal

  2. Pregnancy should be avoided for 1 month following vaccination.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Not recommended, contraindicated or restricted matched: should be avoided

4.8 Undesirable effects

  1. These data suggest one additional case of febrile convulsion per 5 882 or 2 747 subjects vaccinated with Priorix-Tetra compared to matched control cohorts who received MMR or simultaneous, but separate MMR and varicella vaccination (attributable risk of 1.70 (95% CI: -1.86; 3.46) and 3.64 (95% CI: -6.11; 8.30) per 10 000 subjects, respectively) - see section 5.1.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • febrile convulsion - A fit caused by a high temperature, most common in young children. Usually brief and not harmful in itself.

    Rare or very rare serious events matched: convulsion

  2. meningitis, herpes zoster*, measles-like syndrome, mumps-like syndrome (including orchitis, epididymitis and parotitis)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • meningitis - Inflammation of the lining around the brain and spinal cord.

    Rare or very rare serious events matched: meningitis

  3. encephalitis*^+, cerebellitis, cerebrovascular accident, Guillain Barré syndrome, transverse myelitis, peripheral neuritis, cerebellitis like symptoms (including transient gait disturbance and transient ataxia)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • encephalitis - Inflammation of the brain.

    Rare or very rare serious events matched: guillain

  4. Encephalitis has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.
    • encephalitis - Inflammation of the brain.

    Genetic engineering, vectors and GMOs matched: attenuated

  5. Fatal outcome was reported in a few cases, especially in immunocompromised people (see section 4.4).

    Section 4.8 Undesirable effects source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmissionRare or very rare serious events matched: fatal, immunocompromised

5.1 Pharmacodynamic properties

  1. The efficacy of GlaxoSmithKline (GSK)'s monovalent Oka varicella (Varilrix) and Priorix-Tetra vaccines in preventing varicella disease has been evaluated in a large randomised multicountry clinical trial, which included GSK combined measles-mumps-rubella vaccine (Priorix) as active control.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • randomised - A trial where people are assigned to groups by chance.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  2. Vaccine efficacy against epidemiologically confirmed or PCR (Polymerase Chain Reaction) confirmed varicella of any severity (defined using a prespecified scale) and against moderate or severe confirmed varicella was demonstrated after a primary follow-up period of 2 years (median duration 3.2 years).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  3. Persistant efficacy was observed in the same study during the long term follow-up periods of 6 years (median duration 6.4 years) and 10 years (median duration 9.8 years).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  4. Efficacy against confirmed varicella of any severity

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  5. Efficacy against moderate or severe confirmed varicella

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  6. Effectiveness data suggest a higher level of protection and a decrease in breakthrough varicella following two doses of varicella-containing vaccine than following one dose.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  7. The effectiveness of two doses of Priorix-Tetra during varicella outbreaks in day care centres in Germany, where routine varicella vaccination is recommended for children as of 11 months of age, was 91% (95% CI: 65;98) against any disease and 94% (95% CI: 54;99) against moderate disease.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  8. The effectiveness of one dose of Varilrix was estimated in different settings (outbreaks, case-control and database studies) and ranged from 20%-92% against any varicella disease and from 86%-100% against moderate or severe disease.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  9. Several clinical studies evaluated the immune response elicited by Priorix-Tetra administered subcutaneously.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  10. These serological parameters are widely accepted as surrogate markers for immune protection.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • surrogate - A stand-in measurement used instead of the outcome you actually care about.

    Efficacy, effectiveness and endpoints matched: surrogate

  11. A modified commercial indirect immunofluorescence assay (IFA, meanwhile discontinued) and a commercial ELISA were used to compare the immune response against varicella elicited by Priorix-Tetra to that observed with GSK varicella vaccine.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  12. Seroconversion rates and geometric mean antibody concentrations/titres (GMC/GMT) are summarized in the table below.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • seroconversion - A rise in antibodies after vaccination, measured in the blood.

    Efficacy, effectiveness and endpoints matched: geometric mean

  13. Seroconversion rates and geometric mean antibody concentrations/titres were similar to those observed after separate vaccination with Varilrix and Priorix.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • seroconversion - A rise in antibodies after vaccination, measured in the blood.

    Efficacy, effectiveness and endpoints matched: geometric mean

  14. The second dose of Priorix-Tetra induced an increase in seroconversion rates and/or antibody levels for the measles, mumps and rubella vaccine components.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroconversion - A rise in antibodies after vaccination, measured in the blood.

    Efficacy, effectiveness and endpoints matched: seroconversion

  15. Data suggest a higher efficacy and a decrease in breakthrough varicella following two doses of vaccine with respect to one dose.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  16. The immune response of Priorix-Tetra administered as a second dose of MMR vaccine in children 24 months to 6 years of age was evaluated in 2 clinical studies.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  17. Children were previously primed with respectively an MMR vaccine or with an MMR vaccine co-administered with a live attenuated varicella vaccine.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  18. Seropositivity rates for anti-varicella antibodies were 98.1% (IFA) in children previously vaccinated with MMR and 100% in children previously vaccinated with an MMR vaccine co-administered with a live attenuated varicella vaccine.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  19. Immune response in subjects > 6 years of age

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  20. Immune response in children aged 9 to 10 months

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  21. Seroconversion rates and geometric mean antibody concentrations/titres were similar to those observed after separate vaccination with Varilrix and Priorix.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • seroconversion - A rise in antibodies after vaccination, measured in the blood.

    Efficacy, effectiveness and endpoints matched: geometric mean

  22. Seroconversion rates after a first dose of Priorix-Tetra were comparable for all antigens except measles to those seen in 12-24 months old children in other clinical studies.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroconversion - A rise in antibodies after vaccination, measured in the blood.

    Efficacy, effectiveness and endpoints matched: seroconversion

  23. The seroconversion rate reported for measles in infants 9 to 10 months of age following 1 dose of Priorix-Tetra was 93.3% (95% CI: 87.6;96.9).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroconversion - A rise in antibodies after vaccination, measured in the blood.

    Efficacy, effectiveness and endpoints matched: seroconversion

  24. Persistence of measles, mumps and rubella immune response

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  25. As robust efficacy data against varicella disease up to 10 years are provided above (see subsection “Efficacy”) and since there is no threshold for protection against varicella disease established with the obtained immunological data, anti-varicella antibody persistence data are not provided.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

6.6 Special precautions for disposal and other handling

  1. Do not administer if the vaccine presents other colouration or contains other particulate matter.

    Section 6.6 Special precautions for disposal and other handling source ↗

    In plain English

    • do not administer - The label instructs that it must not be given.

    Not recommended, contraindicated or restricted matched: do not administer

Read the whole document at the source ↗