VaxigripTetra NH/VaxigripTetra SH

Quadrivalent influenza vaccine (split virion, inactivated).

VaxigripTetra NH: Influenza virus (inactivated, split) of the following strains*: A/Victoria/2570/2019 (H1N1) pdm09 - like virus (A/Victoria/2570/2019, IVR- 215) 15 micrograms HA**.
A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/9/2021, IVR-228) 15 micrograms HA**.
B/Austria/1359417/2021-like virus (B/Michigan/01/2021, wild type) 15 micrograms HA**.
B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013, wild type) 15 micrograms HA**.
For one 0.5 mL dose.
* propagated in fertilised hens' eggs from healthy chicken flocks.
** haemagglutinin.
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2022/2023 season.
VaxigripTetra NH may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol-9, which are used during the manufacturing process (see Contraindications).
VaxigripTetra SH: Influenza virus (inactivated, split) of the following strains*: A/Sydney/5/2021 (H1N1) pdm09-like virus (A/Sydney/5/2021, SAN-013) 15 micrograms HA**.
A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/9/2021, IVR-228) 15 micrograms HA**.
B/Austria/1359417/2021-like virus (B/Michigan/01/2021, wild type) 15 micrograms HA**.
B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013, wild type) 15 micrograms HA**.
For one 0.5 mL dose.
* propagated in fertilised hens' eggs from healthy chicken flocks.
** haemagglutinin.
This vaccine complies with the WHO recommendations (Southern Hemisphere) for the 2023 season.
VaxigripTetra SH may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and octoxinol-9, which are used during the manufacturing process (see Contraindications).
Excipients/Inactive Ingredients: Buffer Solution: Sodium chloride, Potassium chloride, Disodium phosphate dihydrate, Potassium dihydrogen phosphate, Water for injections.

Pharmacotherapeutic group: influenza vaccine. ATC code: J07BB02.
Pharmacology: Pharmacodynamics: Mechanism of action: VaxigripTetra NH/VaxigripTetra SH provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
VaxigripTetra NH/VaxigripTetra SH induces humoral antibodies against the haemagglutinins within 2 to 3 weeks. These antibodies neutralise influenza viruses.
Specific levels of haemagglutination-inhibition (HAI) antibody titre post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HAI antibody titres have been used as a measure of vaccine activity. In some human challenge studies, HAI antibody titres of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.
Since influenza viruses constantly evolve, the virus strains selected in the vaccine are reviewed annually by the WHO.
Annual revaccination with VaxigripTetra NH/VaxigripTetra SH has not been studied. However, based on clinical experience with the trivalent vaccine, annual influenza vaccination is recommended given the duration of immunity provided by the vaccine and because circulating strains of influenza virus change from year to year.
Efficacy of VaxigripTetra NH/VaxigripTetra SH: Paediatric population: Children from 6 to 35 months of age (active immunisation): A randomized placebo controlled study was conducted in 4 regions (Africa, Asia, Latina America and Europe) over 4 influenza seasons, in more than 5,400 children from 6 to 35 months of age who received two doses (0.5 mL) of VaxigripTetra NH/VaxigripTetra SH (N=2,722), or placebo (N=2,717) 28 days apart to assess VaxigripTetra NH/VaxigripTetra SH efficacy for the prevention of laboratory-confirmed influenza illness caused by any strain A and/or B and caused by vaccine similar strains (as determined by sequencing).
Laboratory-confirmed influenza illness was defined as influenza like-illness (ILI) [occurrence of fever ≥ 38°C (that lasts at least 24 hours) concurrently with at least one of the following symptoms: cough, nasal congestion, rhinorrhoea, pharyngitis, otitis, vomiting, or diarrhoea], laboratory-confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) and/or viral culture. (See Table 1.)


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In addition, a predefined complementary analysis showed VaxigripTetra NH/VaxigripTetra SH prevented 56.6% (95% CI: 37.0; 70.5) of severe laboratory-confirmed influenza illnesses due to any strain, and 71.7% (95% CI: 43.7; 86.9) of severe laboratory-confirmed influenza illnesses due to vaccine similar strains.
Furthermore, subjects receiving VaxigripTetra NH/VaxigripTetra SH were 59.2% (95% CI: 44.4; 70.4) less likely to experience a medically attended influenza illness than subjects receiving placebo.
Severe laboratory-confirmed influenza illnesses were defined as ILI laboratory-confirmed by RT- PCR and/or viral culture with at least one of the following items: fever > 39.5°C for subjects aged < 24 months or ≥ 39.0°C for subjects aged ≥ 24 months, and/or at least one significant ILI symptom which prevents daily activity (cough, nasal congestion, rhinorrhoea, pharyngitis, otitis, vomiting, diarrhoea), and/or one of the following events: acute otitis media, acute lower respiratory infection (pneumonia, bronchiolitis, bronchitis, croup), inpatient hospitalization.
Children from 3 to 8 years of age (active immunisation): Based on immune responses observed in children from 3 to 8 years of age, the efficacy of VaxigripTetra NH/VaxigripTetra SH in this population is expected to be at least similar to the efficacy observed in children from 6 to 35 months (see Children from 6 to 35 months of age as previously mentioned and Immunogenicity of VaxigripTetra NH/VaxigripTetra SH as follows).
Pregnant women: There are no clinical efficacy data describing use of VaxigripTetra NH/VaxigripTetra SH in pregnant women. However, data are available on Vaxigrip (TIV) and cited as follows, and can be extrapolated to VaxigripTetra NH/VaxigripTetra SH.
In the randomised, controlled, phase IV, clinical studies conducted in Mali, Nepal, and South Africa, approximately 5,000 pregnant women received Vaxigrip (TIV) and approximately 5,000 pregnant women received placebo or control vaccine (quadrivalent meningococcal conjugate vaccine) during the second or third trimester of pregnancy. Vaccine efficacy against laboratory-confirmed influenza in pregnant women was evaluated as a secondary endpoint in all three studies.
The studies conducted in Mali and South Africa demonstrated the efficacy of Vaxigrip for the prevention of influenza in pregnant women (during pregnancy and for approximately 6 months post- delivery), following vaccination during these trimesters of pregnancy.
In the study conducted in Nepal, the efficacy of Vaxigrip (TIV) for the prevention of influenza in pregnant women following vaccination during these trimesters of pregnancy was not demonstrated. (See Table 2.)


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Infants younger than 6 months of age born to vaccinated pregnant women (passive protection): Infants younger than 6 months of age are at high risk of influenza, resulting in high rates of hospitalization; however, influenza vaccines are not indicated for use in this age group.
There are no clinical efficacy data in infants born to women vaccinated with VaxigripTetra NH/VaxigripTetra SH during pregnancy; however, efficacy in infants younger than 6 months of age whose mothers received a single 0.5-ml dose of Vaxigrip (TIV) during the second or third trimester has been demonstrated in clinical trials in Nepal, Mali and South Africa and can be extrapolated to VaxigripTetra NH/VaxigripTetra SH. Efficacy of Vaxigrip (TIV) in infants younger than 6 months of age whose mothers were vaccinated during the first trimester has not been studied in these trials. Nevertheless, influenza vaccination during the first trimester should not be postponed (see Use in Pregnancy & Lactation). (See Table 3.)


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The efficacy data indicate a waning of protection in infants born to vaccinated mothers over time after birth.
In the trial conducted in South Africa, vaccine efficacy was highest among infants 8 weeks of age or younger (85.8% [95% CI, 38.3 to 98.4]) and decreased over time; vaccine efficacy was 25.5% (95% CI, -67.9 to 67.8) for infants >8 to 16 weeks of age and 30.4% (95% CI, -154.9 to 82.6) for infants >16 to 24 weeks of age.
In the trial conducted in Mali, there is also a trend of higher efficacy of the trivalent inactivated influenza vaccine in infants during the first 4 months after birth (70.2% [95% CI, 35.7 to 87.6]), with lower efficacy within the fifth month of surveillance (60.7% [95% CI, 33.8 to 77.5]) and a marked fall within the sixth month (37.3% [95% CI, 7.6 to 57.8]).
The prevention of influenza can only be expected if the infants are exposed to the strains included in the vaccine administered to the mother.
Immunogenicity of VaxigripTetra NH/VaxigripTetra SH: Clinical studies performed in adults from 18 to 60 years of age, in elderly over 60 years of age, in children from 3 to 8 years of age and from 6 to 35 months assessed VaxigripTetra NH immune response for HAI Geometric mean antibody titer (GMT) at Day 21 (for adults) and at Day 28 (for children), HAI seroconversion rate (4-fold rise in reciprocal titer or change from undetectable [<10] to a reciprocal titer of ≥40), and HAI GMTR (post-/pre-vaccination titers).
One clinical study performed in adults from 18 to 60 years of age and in children from 9 to 17 years of age described the immune response of VaxigripTetra NH/VaxigripTetra SH for HAI antibody GMT at Day 21. Another clinical study performed in children from 9 to 17 years of age described the immune response of VaxigripTetra NH/VaxigripTetra SH.
One clinical study performed in pregnant women described the immune response of VaxigripTetra NH/VaxigripTetra SH versus Vaxigrip (TIV) for HAI GMT at Day 21, HAI seroconversion rate, and HAI GMTR after one dose administered during the second or third trimester of pregnancy. In this study, the transplacental transfer was evaluated using HAI GMTs of maternal blood, of cord blood and of ratio cord blood/maternal blood, at delivery VaxigripTetra NH/VaxigripTetra SH induced a significant immune response against the 4 influenza strains contained in the vaccine.
Adults and elderly: A total of 832 adults from 18 to 60 years of age and 831 elderly over 60 years of age were assessed in terms of immune response after one dose of VaxigripTetra NH/VaxigripTetra SH.
Immunogenicity results are presented in the tables as follows: See Table 4.


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Pregnant women and transplacental transfer: In a randomised, controlled clinical study conducted in Finland, a total of 230 pregnant women received VaxigripTetra NH/VaxigripTetra SH and 116 pregnant women received Vaxigrip (TIV) during the second or third trimester of pregnancy (from 20 to 32 weeks of pregnancy).
Immunogenicity results by HAI method, in pregnant women 21 days after vaccination with VaxigripTetra NH/VaxigripTetra SH or Vaxigrip (TIV) are presented in Table 5.
Immunogenicity descriptive assessment by HAI method, at delivery, in blood sample of mother (BL03M), in cord blood sample (BL03B) and of the transplacental transfer (BL03B/ BL03M) are presented in Table 5.
At delivery, the level of antibodies in the cord sample compared to the mother sample was almost doubled for the A/H1N1 strain and increased between 1.5 and 1.7 times for the A/H3N2, B/Brisbane, and B/Phuket strains, supporting that there is transplacental antibody transfer from mother to the newborn, following vaccination of women with VaxigripTetra NH/VaxigripTetra SH or Vaxigrip (TIV) during the second or third trimester of pregnancy.
These data are consistent with the passive protection demonstrated in infants from birth to approximately 6 months of age following vaccination of women during the second or third trimester of pregnancy with Vaxigrip (TIV) in studies conducted in Mali, Nepal, and South Africa. (See Table 5.)


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Paediatric population: Children from 9 to 17 years of age: In a total of 429 children from 9 to 17 years of age who received one dose of VaxigripTetra NH/VaxigripTetra SH, the immune response against the 4 strains contained in the vaccine was similar to the immune response induced in adults from 18 to 60 years of age.
Children from 6 months to 8 years of age: A total of 863 children from 3 to 8 years of age received either one or two doses of VaxigripTetra NH/VaxigripTetra SH depending on their previous influenza vaccination history.
Children who received a one- or two-dose schedule of VaxigripTetra NH/VaxigripTetra SH presented a similar immune response following the last dose of each schedule.
In addition to the VaxigripTetra NH/VaxigripTetra SH efficacy, the immunogenicity of two 0.5 mL doses of VaxigripTetra NH/VaxigripTetra SH was assessed 28 days after the last injection of VaxigripTetra NH/VaxigripTetra SH by HAI method in 341 children from 6 to 35 months of age.
Immunogenicity results are presented in the table as follows: See Table 6.


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These immunogenicity data provide supportive information in addition to vaccine efficacy data available in this population (see Efficacy of VaxigripTetra NH/VaxigripTetra SH as previously mentioned).
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Non-clinical data revealed no special hazard for humans based on conventional studies of repeat dose and local toxicity, reproductive and developmental toxicity and safety pharmacology studies.

VaxigripTetra NH/VaxigripTetra SH is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for: active immunisation of adults, including pregnant women, and children from 6 months of age.
Passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Dosage & Administration, Precautions, Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions).
The use of VaxigripTetra NH/VaxigripTetra SH should be based on official recommendations.

Posology: Based on clinical experience with the trivalent vaccine, annual revaccination with influenza vaccine is recommended given the duration of immunity provided by the vaccine and because circulating strains of influenza virus might change from year to year.
Adults: one dose of 0.5 mL.
Paediatric population: Children from 6 months to 17 years of age: one dose of 0.5 mL. For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.
Infants younger than 6 months of age: No data are available regarding the safety and efficacy of VaxigripTetra NH/VaxigripTetra SH administration (active immunisation) in infants younger than 6 months of age.
Regarding passive protection, one 0.5 ml dose given to pregnant women may protect infants from birth to less than 6 months of age; however not all these infants will be protected (see Pharmacology: Pharmacodynamics under Actions).
Method of administration: The vaccine should be given by intramuscular or subcutaneous injection.
The preferred site for intramuscular injection is the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults.
Precautions to be taken before handling or administering the medicinal product: For instructions on preparation of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.

Cases of administration of more than the recommended dose (overdose) have been reported with VaxigripTetra NH/VaxigripTetra SH. When adverse reactions were reported, the information was consistent with the known safety profile of VaxigripTetra NH/VaxigripTetra SH described in Adverse Reactions.

Hypersensitivity to the active substances, to any of the excipients listed in Description or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9.
Vaccination should be postponed in case of moderate or severe febrile disease or acute disease.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
VaxigripTetra NH/VaxigripTetra SH should under no circumstances be administered intravascularly.
As with other vaccines administered intramuscularly, the vaccine should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.
VaxigripTetra NH/VaxigripTetra SH is intended to provide protection against those strains of influenza virus from which the vaccine is prepared.
As with any vaccine, vaccination with VaxigripTetra NH/VaxigripTetra SH may not protect all vaccinees.
Regarding passive protection, not all infants younger than 6 months of age born to women vaccinated during pregnancy will be protected (see Pharmacology: Pharmacodynamics under Actions).
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Interference with serological testing: See Interactions.
Effects on ability to drive and use machines: VaxigripTetra NH/VaxigripTetra SH has no or negligible influence on the ability to drive and use machines.

Pregnancy: Data from four clinical studies conducted with Vaxigrip (trivalent influenza vaccine, TIV) administered to pregnant women during the second and third trimesters (more than 5,000 exposed pregnancies and more than 5,000 live births, followed up to approximately 6 months postpartum) did not indicate any adverse fetal, newborn, infant, or maternal outcomes attributable to the vaccine.
In three of these clinical studies conducted in South Africa and Nepal, there were no significant differences between the Vaxigrip (TIV) and placebo groups with regards to fetal, newborn, infant, or maternal outcomes (including miscarriage, stillbirth, premature birth, low birth weight).
In the fourth study conducted in Mali, there were no significant differences between the Vaxigrip (TIV) and control vaccine (quadrivalent meningococcal conjugate vaccine) groups with regards to prematurity rate, stillbirth rate, or rate of low birth weight/small for gestational age.
Data from a clinical study conducted in Finland with VaxigripTetra NH/VaxigripTetra SH administered in pregnant women during the second or third trimester (230 exposed pregnancies and 231 live births) did not indicate any adverse fetal or maternal outcomes attributable to the vaccine.
VaxigripTetra NH/VaxigripTetra SH can be administered in all stages of pregnancy based on the safety data from clinical studies and post-marketing experience. Because of the known adverse consequences of influenza infection in pregnant women, health authorities recommend vaccination of pregnant women.
One animal study with VaxigripTetra NH/VaxigripTetra SH did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.
Breastfeeding: There are no data on the use of VaxigripTetra NH/VaxigripTetra SH in breastfeeding women.
Based on experience with inactivated influenza vaccines, VaxigripTetra NH/VaxigripTetra SH may be used during breastfeeding.
Fertility: There are no fertility data available in Humans. One animal study with VaxigripTetra NH/VaxigripTetra SH did not indicate harmful effects on female fertility.

Summary of the safety profile: The safety of VaxigripTetra NH/VaxigripTetra SH was assessed in six clinical trials in which 3,040 adults from 18 to 60 years of age, 1,392 elderly over 60 years of age and 429 children from 9 to 17 years of age received one dose of VaxigripTetra NH/VaxigripTetra SH, 884 children from 3 to 8 years of age received one or two doses of VaxigripTetra NH/VaxigripTetra SH depending on their influenza vaccination history and 1614 children from 6 to 35 months of age received two doses (0.5 mL) of VaxigripTetra NH/VaxigripTetra SH.
Most reactions usually occurred within the first 3 days following vaccination, resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was mild.
The most frequently reported adverse reaction after vaccination, in all populations, including the whole group of children from 6 to 35 months of age, was injection site pain (between 52.8% and 56.5% in children from 3 to 17 years of age and in adults, 26.8% in children from 6 to 35 months of age and 25.8% in elderly). In subpopulation of children less than 24 months of age, irritability (32.3%) was the most frequently reported adverse reaction.
In subpopulation children from 24 to 35 months of age, malaise (26.8%) is the most frequently reported adverse reaction.
The other most frequently reported adverse reactions after vaccination were: In adults: headache (27.8%), myalgia (23%) and malaise (19.2%); In elderly: headache (15.6%) and myalgia (13.9%); In children from 9 to 17 years of age: myalgia (29.1%), headache (24.7%), malaise (20.3%) and injection site swelling (10.7%); In children from 3 to 8 years of age: malaise (30.7%), myalgia (28.5%), headache (25.7%), injection site swelling (20.5%), injection site erythema (20.4%), injection site induration (16.4%), shivering (11.2%); For all children from 6 to 35 months of age: fever (20.4%) and injection site erythema (17.2%); In children less than 24 months of age: appetite lost (28.9%), crying abnormal (27.1%), vomiting (16.1%) and drowsiness (13.9%); In children from 24 months to 35 months of age: headache (11.9%) and myalgia (11.6%).
Adverse reactions were generally less frequent in the elderly than in adults and children.
Tabulated summary of adverse reactions: The data as follows summarize the frequencies of the adverse reactions that were recorded following vaccination with VaxigripTetra NH/VaxigripTetra SH during clinical trials and worldwide post-marketing surveillance.
Adverse events are ranked under headings of frequency using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000). Not known (cannot be estimated from available data).
Adults and elderly: The safety profile presented as follows is based on: data from 3,040 adults from 18 to 60 years of age and 1,392 elderly over 60 years of age; data from worldwide post-marketing surveillance (*). (See Table 7.)


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Paediatric population: The safety profile presented as follows is based on: data from 429 children from 9 to 17 years of age who received one dose of VaxigripTetra NH/VaxigripTetra SH and from 884 children from 3 to 8 years of age who received one or two doses of VaxigripTetra NH/VaxigripTetra SH depending on their influenza vaccination history; data from worldwide post-marketing surveillance (*). (See Table 8.)


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The safety profile presented as follows is based on: data from 1,614 children from 6 to 35 months of age who received two doses of VaxigripTetra NH/VaxigripTetra SH; data from worldwide post-marketing surveillance (*). (See Table 9.)


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In children from 6 months to 8 years of age, the safety profile of VaxigripTetra NH/VaxigripTetra SH was similar after the first and the second injections with a trend of lower incidence of adverse reactions after the second injection compared to the first one in children from 6 to 35 months of age.
Adverse events: The following adverse events were reported following commercial use of Vaxigrip. A causal relationship with VaxigripTetra NH/VaxigripTetra SH has not been established.
Blood and lymphatic system disorders: Transient thrombocytopenia⁽¹⁾, lymphadenopathy⁽¹⁾.
Nervous system disorders: Paraesthesia⁽¹⁾, Guillain-Barré Syndrome (GBS), neuritis, neuralgia, convulsions, encephalomyelitis.
Vascular disorders: Vasculitis, such as Henoch-Schönlein purpura, with transient renal involvement in certain cases.
⁽¹⁾ These adverse events were reported during clinical trials only in some age groups (see Tabulated summary of adverse reactions as previously mentioned).
Other special populations: The safety profile of VaxigripTetra NH/VaxigripTetra SH observed in a limited number of subjects with co-morbidities enrolled in the clinical studies does not differ from the one observed in the overall population. In addition, studies conducted with Vaxigrip in renal transplant patients, and asthmatic patients showed no major differences in terms of safety profile of Vaxigrip in these populations.
Pregnant women: In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (TIV) (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), frequencies of local and systemic solicited reactions reported within 7 days following administration of Vaxigrip, were generally consistent with those reported for the adult population during clinical studies conducted with Vaxigrip; In the study conducted in South Africa, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts.
There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.
In one clinical study conducted in pregnant women in Finland with VaxigripTetra NH/VaxigripTetra SH (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics: Immunogenicity of VaxigripTetra NH/VaxigripTetra SH under Actions), frequencies of local and systemic solicited reactions reported within 7 days following administration of VaxigripTetra NH/VaxigripTetra SH were consistent with those reported for the non-pregnant adult population during clinical studies conducted with VaxigripTetra NH/VaxigripTetra SH even though higher for some adverse reactions (injection site pain, malaise, shivering, headache, myalgia). When higher frequencies were observed, this increase was also seen with Vaxigrip (TIV), used as comparator, suggesting a clinical study effect in this pregnant women population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

No interaction studies have been performed with VaxigripTetra NH/VaxigripTetra SH.
VaxigripTetra NH/VaxigripTetra SH can be given at the same time as other vaccines, based on clinical experience with Vaxigrip. Separate injection sites and separate needles should be used in case of concomitant administration.
The immunological response may be reduced if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive results could be due to the IgM response by the vaccine.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: The vaccine should be allowed to reach room temperature before use. Shake before use. Inspect visually prior to administration.
The vaccine should not be used if foreign particles are present in the suspension.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

Vaccines, Antisera & Immunologicals

J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.

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