VAXIGRIPTETRA 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 infants less than 6 months of age and born to women vaccinated during
pregnancy (see Sections 4.4, 4.6 and 5.1).
The use of VAXIGRIPTETRA 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.
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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 less than 6 months of age: the safety and efficacy of VAXIGRIPTETRA administration
(active immunisation) have not been established. No data are available.
• Regarding passive protection, one 0.5 mL dose administered to a pregnant woman may
protect infants from birth to almost 6 months of age; however, not all infants may be protected
(see section 5.1).
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 section 6.6.

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of
the administered product should be clearly recorded.
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 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 is intended to provide protection against those strains of influenza virus from which
the vaccine is prepared.
As with any vaccine, vaccination with VAXIGRIPTETRA may not protect all vaccinees.
Regarding passive protection, not all infants less than 6 months of age born to women vaccinated
during pregnancy may be protected (see section 5.1).
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Interference with serological testing
See section 4.5. 

VAXIGRIPTETRA contains potassium and sodium
This vaccine contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per
dose, that is to say it is essentially “potassium-free” and “sodium-free”.

No interaction studies have been performed with VAXIGRIPTETRA.
VAXIGRIPTETRA 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. 

Pregnancy
Pregnant women are at high risk of influenza complications, including premature labour and delivery,
hospitalisation, and death: pregnant women should receive an influenza vaccine.
VAXIGRIPTETRA can be used in all stages of pregnancy.
Larger datasets on safety of inactivated influenza vaccines are available for the second and third
trimesters, than for the first trimester. Data from worldwide use of inactivated influenza vaccines,
including VAXIGRIPTETRA and Vaxigrip (trivalent inactivated influenza vaccine), do not indicate any
adverse foetal and maternal outcomes attributable to the vaccine. This is consistent with results
observed in one clinical study where VAXIGRIPTETRA and Vaxigrip were administered in pregnant
women during the second or third trimester (230 exposed pregnancies and 231 live births for
VAXIGRIPTETRA and 116 exposed pregnancies and 119 live births for Vaxigrip).
Data from four clinical studies with the trivalent inactivated influenza vaccine (Vaxigrip) administered in
pregnant women during the second or third trimester (more than 5,000 exposed pregnancies and
more than 5,000 live births followed up to approximately 6 months post-partum) do not indicate any
adverse foetal, newborn, infant and maternal outcomes attributable to the vaccine.
In clinical studies conducted in South Africa and Nepal, there were no significant differences between
the Vaxigrip and placebo groups with regards to foetal, newborn, infant and maternal outcomes
(including miscarriage, stillbirth, premature birth, low birth weight).
In a study conducted in Mali, there were no significant differences between the Vaxigrip and control
vaccine (quadrivalent meningococcal conjugate vaccine) groups with regards to prematurity rate,
stillbirth rate and low birth weight/small for gestational age rate.
For additional information, see Sections 4.8 and 5.1.
One animal study with VAXIGRIPTETRA did not indicate direct or indirect harmful effects with respect
to pregnancy, embryo-foetal development or early post-natal development.
Breastfeeding
VAXIGRIPTETRA may be used during breastfeeding.
Fertility
There are no fertility data available in Humans. One animal study with VAXIGRIPTETRA did not
indicate harmful effects on female fertility. 

VAXIGRIPTETRA has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile
The safety of VAXIGRIPTETRA 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, 884 children from 3 to 8 years of age received one or two doses of
VAXIGRIPTETRA depending on their influenza vaccination history and 1614 children from 6 to
35 months of age received two doses (0.5 ml) of VAXIGRIPTETRA.
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 below summarize the frequencies of the adverse reactions that were recorded following
vaccination with VAXIGRIPTETRA 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): adverse reactions have been spontaneously
reported following commercial use of VAXIGRIPTETRA. Because these reactions are reported
voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
Within each frequency grouping, the adverse reactions are presented in decreasing order of
seriousness. 

Adults and elderly
The safety profile presented below 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 (*).

Paediatric population
The safety profile presented below is based on:
• data from 429 children from 9 to 17 years of age who received one dose of VAXIGRIPTETRA
and from 884 children from 3 to 8 years of age who received one or two doses of
VAXIGRIPTETRA depending on their influenza vaccination history.
• data from worldwide post-marketing surveillance (*).

In children from 6 months to 8 years of age, the safety profile of VAXIGRIPTETRA 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 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).
Other special populations
The safety profile of VAXIGRIPTETRA 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 (see Sections
4.6 and 5.1), the frequencies of local and systemic solicited reactions reported within 7 days following
administration of the vaccine were consistent with those reported for the adult population during
clinical studies conducted with Vaxigrip. In the South Africa study, 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 (see sections 4.6
and 5.1), frequencies of local and systemic solicited reactions reported within 7 days following
administration of VAXIGRIPTETRA were consistent with those reported for the adult population (with
the exception of pregnant women) during clinical studies conducted with VAXIGRIPTETRA even
though higher for some adverse reactions (injection site pain, malaise, shivering, headache, myalgia).
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. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system:
To reports any side effect(s):
Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
Other GCC States:
- Please contact the relevant competent authority.
Sanofi Pharmacovigilance:
- KSA_Pharmacovigilance@sanofi.com

Cases of administration of more than the recommended dose (overdose) have been reported with
VAXIGRIPTETRA. When adverse reactions were reported, they were consistent with the safety profile
of VAXIGRIPTETRA described in Section 4.8.

Efficacy of VAXIGRIPTETRA
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 (N=2,722), or placebo (N=2,717) 28 days apart to
assess VAXIGRIPTETRA 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.
Table 1: Influenza Attack Rates and VAXIGRIPTETRA Efficacy against laboratory-confirmed
influenza illness in children from 6 to 35 months of age
VAXIGRIPTETRA
(N=2,584)
Placebo
(N=2,591)
Efficacy
n Influenza
attack rate
(%)
n Influenza
attack rate
(%)
% (2-sided 95% CI)
Laboratory-confirmed influenza illness
caused by:
- Any influenza A or B type 122 4.72 255 9.84 52.03 (40.24; 61.66)
- Viral strains similar to those
contained in the vaccine
26 1.01 85 3.28 69.33 (51.93; 81.03)
N: Number of children analysed (full set)
n: number of subjects fulfilling the item listed
CI: Confidence Interval
In addition, a predefined complementary analysis showed VAXIGRIPTETRA 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 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:
o fever > 39.5°C for subjects aged < 24 months or ≥ 39.0°C for subjects aged ≥ 24 months,
o and/or at least one significant ILI symptom which prevents daily activity (cough, nasal
congestion, rhinorrhoea, pharyngitis, otitis, vomiting, diarrhoea),
o and/or one of the following events: acute otitis media, acute lower respiratory infection
(pneumonia, bronchiolitis, bronchitis, croup), inpatient hospitalisation.
• 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 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” above and “Immunogenicity
of VAXIGRIPTETRA“ below).
• Infants less than 6 months of age born to women vaccinated during pregnancy (passive
protection):
Infants less than 6 months of age are at high risk of influenza, resulting in high rates of hospitalisation;
however, influenza vaccines are not indicated for active immunisation in this age group.
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The efficacy in infants born to women who received a single 0.5 mL dose of VAXIGRIPTETRA during
the second or third trimester of pregnancy has not been studied; however, the efficacy in infants born
to women who received a single 0.5 mL dose of the trivalent inactivated influenza vaccine (Vaxigrip)
during the second or third trimester of pregnancy has been demonstrated in clinical trials and can be
extrapolated to VAXIGRIPTETRA.
The efficacy of the trivalent inactivated influenza vaccine (Vaxigrip) in infants born to women
vaccinated during the first trimester of pregnancy has not been studied in these trials. If influenza
vaccination is considered necessary during the first trimester of pregnancy, it should not be postponed
(see section 4.6).
In randomised, controlled phase IV clinical studies conducted in Mali, Nepal and South Africa,
approximately 5,000 pregnant women received Vaxigrip (trivalent influenza vaccine) and
approximately 5,000 pregnant women received a placebo or control vaccine (quadrivalent
meningococcal conjugate vaccine) during the second or third trimester of pregnancy. Vaccine efficacy
against laboratory confirmed influenza illness 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 following vaccination during these trimesters of pregnancy
(see table 2). In the study conducted in Nepal, the efficacy of Vaxigrip for the prevention of influenza in
pregnant women following vaccination during these trimesters of pregnancy was not demonstrated.
Table 2: Influenza Attack Rates and Vaxigrip Efficacy against laboratory-confirmed influenza
Illness in pregnant women
Influenza Attack Rate
(Any influenza A or B type)
% (n/N)
Vaxigrip Efficacy
% (95% CI)
Vaxigrip Control*
Mali 0.5 (11/2,108) 1.9 (40/2,085) 70.3 (42.2; 85.8)
Vaxigrip Placebo
South Africa 1.8 (19/1,062) 3.6 (38/1,054) 50.4 (14.5; 71.2)
* Meningococcal vaccine
N: Number of pregnant women included in analysis
n: number of subjects with laboratory confirmed infuenza illness
CI: Confidence Interval
In the same randomised, controlled, phase IV clinical studies conducted in Mali, Nepal and South
Africa, 4,530 of the 4,898 (92%) infants born to women who received Vaxigrip (trivalent influenza
vaccine) during the second or third trimester of pregnancy, and 4,532 of the 4,868 (93%) infants born
to pregnant women who received a placebo or control vaccine (quadrivalent meningococcal conjugate
vaccine) during the second or third trimester of pregnancy (see table 3) were followed-up until
approximately 6 months of age.
These studies confirmed the efficacy of Vaxigrip for the prevention of influenza in infants born to
women vaccinated during these trimesters of pregnancy, from birth until approximately 6 months of
age. Women in their first trimester of pregnancy were not included in these studies; the efficacy of
Vaxigrip in infants born to women vaccinated during the first trimester of pregnancy could therefore not
be evaluated.
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Table 3: Influenza Attack Rates and Vaxigrip Efficacy against Laboratory-confirmed influenza
illness in infants born to women vaccinated during pregnancy
Influenza Attack Rate
(Any influenza A or B type)
% (n/N)
Vaxigrip Efficacy
% (95% CI)
Vaxigrip Control*
Mali 2.4 (45/1,866) 3.8 (71/1,869) 37.3 (7.6; 57.8)
Vaxigrip Placebo
Nepal 4.1 (74/1,820) 5.8 (105/1,826) 30.0 (5; 48)
South Africa 1.9 (19/1,026) 3.6 (37/1,023) 48.8 (11.6; 70.4)
* Meningococcal vaccine
N: Number of infants included in the analysis
n: number of subjects with laboratory-confirmed influenza illness
CI: Confidence Interval
The efficacy data indicate a waning protection over time, after birth, of the infants born to women
vaccinated during pregnancy.
In the trial conducted in South Africa, vaccine efficacy was higher in infants 8 weeks of age or younger
(85.8% [95% CI: 38.3; 98.4]) and decreased over time; vaccine efficacy was 25.5% (95% CI: -67.9;
67.8) for infants from 8 to 16 weeks of age and 30.4% (95% CI: -154.9; 82.6) for infants from 16 to 24
weeks of age.
In the trial conducted in Mali, there is also a trend to higher efficacy of the trivalent inactivated
influenza vaccine in infants during the first 4 months after birth, with lower efficacy within the 5th month
and a marked fall during the 6th month where protection is no longer evident.
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
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 immune
response for HAI Geometric mean antibody titre (GMT) at Day 21 (for adults) and at Day 28 (for
children), HAI seroconversion rate (4-fold rise in reciprocal titre or change from undetectable [<10] to a
reciprocal titre of ≥40), and HAI GMTR (post-/pre-vaccination titres).
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 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.
One clinical study performed in pregnant women described the immune response of
VAXIGRIPTETRA 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 the ratio of cord
blood/maternal blood, at delivery.
VAXIGRIPTETRA induced a significant immune response against the 4 influenza strains contained in
the vaccine.
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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.
Immunogenicity results are presented in the tables below:
Table 4: Immunogenicity results in adults from 18 to 60 years of age and in elderly over 60
years of age
Antigen strain 18 to 60 years of age Over 60 years of age
N=832 N=831
GMT (95% CI)
A (H1N1) (a)(b) 608 (563; 657) 219 (199; 241)
A (H3N2) 498 (459; 541) 359 (329; 391)
B (Victoria) 708 (661; 760) 287 (265; 311)
B (Yamagata) 1715 (1607; 1830) 655 (611; 701)
SC % (95% CI) (c)
A (H1N1) (a)(b) 64.1 (60.7; 67.4) 45.6 (42.1; 49.0)
A (H3N2) 66.2 (62.9; 69.4) 47.5 (44.1; 51.0)
B (Victoria) 70.9 (67.7; 74.0) 45.2 (41.8; 48.7)
B (Yamagata) 63.7 (60.3; 67.0) 42.7 (39.3; 46.2)
GMTR (95% CI) (d)
A (H1N1) (a)(b) 9.77 (8.69; 11.0) 4.94 (4.46; 5.47)
A (H3N2) 10.3 (9.15; 11.5) 5.60 (5.02; 6.24)
B (Victoria) 11.6 (10.4; 12.9) 4.61 (4.18; 5.09)
B (Yamagata) 7.35 (6.66; 8.12) 4.11 (3.73; 4.52)
N= number of subjects with available data for the considered endpoint
GMT: Geometric Mean Titre; CI: Confidence Interval;
(a) N=833 for 18-60 years of age group
(b) N=832 for over 60 years of age group (c) SC: Seroconversion or significant increase: for subjects with a pre-vaccination titre
<10 (1/dil), proportion of subjects with a post-vaccination titre ≥ 40 (1/dil) and for subjects with a pre-vaccination titre ≥10 (1/dil),
proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titre
(d) GMTR: Geometric mean of individual titre ratios (post-/pre-vaccination titres)
Pregnant women and transplacental transfer
A total of 230 pregnant women received VAXIGRIPTETRA 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 are presented in table 5.
Table 5: Immunogenicity results by HAI method in pregnant women, 21 days post-vaccination
with VAXIGRIPTETRA
Antigen Strain
VAXIGRIPTETRA
N=216
GMT (95% CI)
A (H1N1)* 525 (466; 592)
A (H3N2)* 341 (286; 407)
B1 (Victoria)* 568 (496; 651)
B2 (Yamagata)* 993 (870; 1134)
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Antigen Strain
VAXIGRIPTETRA
N=216
≥4-fold-rise n (%) (a)
A (H1N1)* 38.0 (31.5; 44.8)
A (H3N2)* 59.3 (52.4; 65.9)
B1 (Victoria)* 61.1 (54.3; 67.7)
B2 (Yamagata)* 59.7 (52.9; 66.3)
GMTR (95% CI) (b)
A (H1N1)* 3.81 (3.11; 4.66)
A (H3N2)* 8.63 (6.85; 10.9)
B1 (Victoria)* 8.48 (6.81; 10.6)
B2 (Yamagata)* 6.26 (5.12; 7.65)
* A/H1N1: A/Michigan/45/2015 (H1N1) pdm09-like virus;
A/H3N2: A/Hong Kong/4801/2014 (H3N2)-like virus;
B1: B/Brisbane/60/2008-like virus (B/Victoria lineage);
B2: B/Phuket/3073/2013-like virus (B/Yamagata lineage)
N= number of subjects with available data for the considered endpoint
GMT: Geometric Mean Titre; CI: Confidence Interval
(a) SC: Seroconversion or significant increase: for subjects with a pre-vaccination titre <10 (1/dil), proportion of subjects with a
post-vaccination titre ≥40 (1/dil) and for subjects with a pre-vaccination titre ≥10 (1/dil), proportion of subjects with a ≥four-fold
increase from pre- to post-vaccination titre
(b) GMTR: Geometric mean of individual titre ratios (post-/pre-vaccination titres)
Immunogenicity descriptive assessment by HAI method, at delivery, in blood sample of mother (BL03M)
and in cord blood sample (BL03B) and of the transplacental transfer (BL03B/BL03M) are presented in
table 6.
Table 6: Immunogenicity descriptive assessment by HAI method of VAXIGRIPTETRA, at delivery
Antigen Strain
VAXIGRIPTETRA
N=178
BL03M (Maternal blood)
GMT (95% CI)
A (H1N1)* 304 (265; 349)
A (H3N2)* 178 (146; 218)
B1 (Victoria)* 290 (247; 341)
B2 (Yamagata)* 547 (463; 646)
BL03B (Cord blood)
GMT (95% CI)
A (H1N1)* 576 (492; 675)
A (H3N2)* 305 (246; 379)
B1 (Victoria)* 444 (372; 530)
B2 (Yamagata)* 921 (772; 1099)
Transplacental transfer: BL03B/BL03M§
GMT (95% CI)
A (H1N1)* 1.89 (1.72; 2.08)
A (H3N2)* 1.71 (1.56; 1.87)
B1 (Victoria)* 1.53 (1.37; 1.71)
B2 (Yamagata)* 1.69 (1.54; 1.85)
N: number of subjects with available data for the considered endpoint: women who received VAXIGRIPTETRA, delivered at
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least 2 weeks after injection and with available cord blood and mother blood at the time of delivery.
* A/H1N1: A/Michigan/45/2015 (H1N1) pdm09-like virus;
A/H3N2: A/Hong Kong/4801/2014 (H3N2)-like virus;
B1: B/Brisbane/60/2008-like virus (B/Victoria lineage)
B2: B/Phuket/3073/2013-like virus (B/Yamagata lineage)
§ If a mother has X babies, her titres values is counted X times
At delivery, the higher level of antibodies in the cord sample compared to the maternal blood sample is
consistent with transplacental antibody transfer from mother to the foetus following vaccination of
women with VAXIGRIPTETRA 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 in studies conducted in Mali, Nepal, and South Africa (see subsection
Efficacy of VAXIGRIPTETRA).
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, 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
depending on their previous influenza vaccination history.
Children who received a one- or two-dose schedule of VAXIGRIPTETRA presented a similar immune
response following the last dose of each schedule.
In addition to the VAXIGRIPTETRA efficacy, the immunogenicity of two 0.5 mL doses of
VAXIGRIPTETRA was assessed 28 days after the last injection of VAXIGRIPTETRA by HAI method
in 341 children from 6 to 35 months of age.
Immunogenicity results are presented in the table below:
Table 7: Immunogenicity results in children from 6 months to 8 years of age
Antigen strain 6-35 months of age 3-8 years of age
N=341 N=863
GMT (95% CI)
A (H1N1) 641 (547; 752) 971 (896; 1052)
A (H3N2) 1071 (925; 1241) 1568 (1451; 1695)
B (Victoria) 623 (550; 706) 1050 (956; 1154)
B (Yamagata) (a) 1010 (885; 1153) 1173 (1,078; 1,276)
SC % (95% CI) (b)
A (H1N1) 90.3 (86.7; 93.2) 65.7 (62.4; 68.9)
A (H3N2) 90.3 (86.7; 93.2) 64.8 (61.5; 68.0)
B (Victoria) 98.8 (97.0; 99.7) 84.8 (82.3; 87.2)
B (Yamagata) (a) 96.8 (94.3; 98.4) 88.5 (86.2; 90.6)
GMTR (95% CI) (c)
A (H1N1) 36.6 (30.8; 43.6) 6.86 (6.24; 7.53)
A (H3N2) 42.6 (35.1; 51.7) 7.49 (6.72; 8.35)
B (Victoria) 100 (88.9; 114) 17.1 (15.5; 18.8)
B (Yamagata) (a) 93.9 (79.5; 111) 25.3 (22.8; 28.2)
N=number of subjects with available data for the considered endpoint
GMT: Geometric Mean Titre; CI: Confidence Interval;
(a) N=862 for 3-8 years of age group
(b) SC: seroconversion or significant increase: for subjects with a pre-vaccination titre <10 (1/dil), proportion of subjects with a
post-vaccination titre ≥40 (1/dil) and for subjects with a pre-vaccination titre ≥10 (1/dil), proportion of subjects with a ≥four-fold
increase from pre- to post-vaccination titre
(c) GMTR: Geometric mean of individual titre ratios (post-/pre-vaccination titres)
VaxigripTetra syringe – Product Information EN - Southern Hemisphere 2024 15
These immunogenicity data provide supportive information in addition to vaccine efficacy data
available in this population (see Efficacy of VAXIGRIPTETRA).

Not applicable.

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.

Buffer Solution:
• Sodium chloride
• Potassium chloride
• Disodium phosphate dihydrate
• Potassium dihydrogen phosphate
• Water for injections

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.

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

0.5 mL of suspension in pre-filled syringe (type I glass) with attached needle, equipped with a plunger
stopper (elastomer chlorobutyl or bromobutyl) – box of 1, 10 or 20.
0.5 mL of suspension in pre-filled syringe (type I glass) without needle, equipped with a plunger
stopper (elastomer chlorobutyl or bromobutyl) – box of 1, 10 or 20.
Not all pack sizes may be marketed.

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.