BOOSTRIXTETRA is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis in subjects from the age of 4 years (see section 4.2). >

BOOSTRIXTETRA is not indicated for primary vaccination.

The administration of BOOSTRIXTETRA should be based on official recommendations.

Dosage

A single dose of 0.5 ml is recommended.

BOOSTRIXTETRA can be administered from the age of 4.

BOOSTRIXTETRA contains diphtheria, tetanus and pertussis antigens in reduced doses in combination with poliomyelitis antigens. Therefore, BOOSTRIXTETRA should be administered in accordance with official recommendations and / or local practices.


BOOSTRIXTETRA may be used in subjects with wounds at tetanus risk who have previously received a primary vaccination with a tetanus vaccine and for whom a booster against diphtheria, pertussis and poliomyelitis is indicated. Tetanus immunoglobulins must be administered concomitantly according to the official recommendations.

Booster injections against diphtheria, tetanus, pertussis and poliomyelitis must be carried out at intervals in accordance with official recommendations.
Pediatric population

The safety and efficacy of BOOSTRIXTETRA in children less than 4 years of age have not been evaluated.
Mode of administration

BOOSTRIXTETRA should be administered intramuscularly, preferably in the deltoid muscle (see Warnings and Precautions for Use).


Class, Pharmacotherapeutic, VACCINE AGAINST DIPHTERIA, TETANOS, COQUELUCHE AND POLIOMYELITY, ATC code J07CA 02.
The immune responses obtained with BOOSTRIXTETRA were evaluated in clinical trials on subjects of different age and immunization history (see section 4.4).

One month after vaccination with BOOSTRIXTETRA, immune responses were as follows

Antigen

Answer

Elderly topics of

10 to 93 years old

(% Of vaccinated)

N '= 690

Elderly topics of

4 to 8 years old

(% Of vaccinated)

N '= 779

Diphtheria

³ 0.1 IU / ml

³ 0.016 IU / ml *

83.5% - 100%

87.7% - 100%

1

NA

Tetanic

³ 0.1 IU / ml

99.6% - 100%

99.9%

Whooping cough

Pertussis anatoxin

Hemagglutinin, filamentous

Pertactine

Immunization response **

Vaccine response

Vaccine response

94.2% - 97.1%

96.9% - 97.2%

96.6% -99.3%

97.8%

90.1%

96.5%

Inactivated poliomyelitis

Type 1

Type 2

Type 3

Seroprotection ³ 8

Seroprotection ³ 8

Seroprotection ³ 8

99.6% - 100%

99.6% - 100%

99.1% - 100%

1

1

1

* Percentage of subjects with a seroprotective level (³ 0.1 IU / ml by ELISA or ³ 0.016 IU / ml by an in vitro neutralization assay on Vero cells)

** Defined as an antibody titre ³ 5U.EL / ml in subjects who were seronegative before, recall or at least a doubling of the antibody concentration in subjects who were seropositive before the recall

In clinical trials, seroprotection and vaccine response rates at all, antigens after booster dose with BOOSTRIXTETRA were similar to those obtained with the marketed vaccines studied.
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As with other diphtheria-tetanus vaccines for adults, BOOSTRIXTETRA induces higher seroprotection rates and anti-D and anti-T antibody titers in children and adolescents than in 'Adult.

Five years after BOOSTRIXTETRA vaccination in children aged 4 to 8 years, the following seropositivity / seropositivity rates were observed in vaccinated subjects according to protocol 1

Antigen

Answer (2)

Children aged 4 to 8 years

(% Of vaccinated)

(N '= 337)

Diphtheria

³ 0.1 IU / ml

89.4%

³ 0.016 UI / ml (3)

98.2%

Tetanic

³ 0.1 IU / ml

98.5%

Whooping cough

Pertussis anatoxin

Hemagglutinin, filamentous

Pertactine

³ 5 U.EL / ml

40.9%

99.7%

97.1%

Poliovirus of type 1

Poliovirus of type 2

Poliovirus of type 3

≥ 8 ED50

98,8%

99.7%

97.1%

(1) According to the protocol, includes all eligible subjects who received a single BOOSTRIXTETRA booster dose and for which the immunogenicity data were available for at least one antigen at a given time. >

(2) Response: After 5 years, diphtheria antibody concentration and tetanus ³ 0.1 IU / ml was considered seroprotective, antibody pertussis concentration ³ 5 U. EL / ml was considered seropositive and the titers of dilutions against 1, 2 and 3 polioviruses of 1: 8 were considered positive.

(3) Percentage of subjects with antibody-associated antibody concentrations (³, 0.1 μl / ml by ELISA assay, or ³ 0.016 IU / ml by an in vitro neutralization assay on Vero cells ).

N '= minimum number of subjects, with data available for each antigen

Three years, three and a half years, five years, and ten years after a first vaccination with BOOSTRIX [containing valences, diphtheria (reduced dose), tetanus, pertussis, contained in BOOSTRITETRA], the following seroprotection / seropositivity rates; Were observed in subjects vaccinated according to protocol 1

Antigen

Answer (2)

Adults and adolescents aged 10 years and over

(% Of vaccinated)

Persistence at 3-3.5 years

Persistence at 5 years

Persistence at 10 years

Adult (3)

(N '= 309)

Adolescent (3)
(N '= 261)

Adult (3)

(N '= 232)

Adolescent (3)
(N '= 250)

Adult (3)

(N '= 158)

Adolescent (3)
(N '= 74)

Diphtheria

³ 0.1 IU / ml

71.2%

91.6%

84.1%

86,8%

64,6%

82,4%

³ 0.016 UI / ml (4)

97.4%

1

94,4%

99.2%

89.9%

98.6%

Tetanic

³ 0.1 IU / ml

94.8%

1

96.2%

1

95.0%

97.3%

Whooping cough

³ 5 U.EL / ml

Anatoxin, pertussis

90.6%

81.6%

89.5%

76,8%

85.6%

61.3%

Hemagglutinin, filamentous

1

1

1

1

99.4%

1

Pertactine

94.8%

99.2%

95.0%

98.1%

95.0%

96.0%

(1) According to the protocol, includes all eligible subjects who received a single BOOSTRIX booster dose and for which the immunogenicity data were available for at least one antigen at a given time. >

(2) Response: At a given time, a concentration of antibody to diphtheria and tetanus ³ 0.1 IU / ml was considered seroprotective and an antibody against pertussis ³ 5 U .EL / ml was considered to be seropositive.

(3) The terms "adult" and "adolescent" reflect the age at which the subjects received their first vaccination with BOOSTRIX.
(4) Percentage of subjects with antibody-associated antibody concentrations (³, 0.1 μl / ml by ELISA, or ³ 0.016 IU / ml by an in vitro neutralization assay on Vero cells ).

N '= minimum number of subjects with data available for each antigen

The immunogenicity of BOOSTRIXTETRA, administered 5 years after a first booster dose of BOOSTRIXTETRA at the age of 4 to 8 years, was evaluated. After vaccination, 99% or more of the subjects were seropositive against pertussis and seroprotected against diphtheria, tetanus and the three types of poliovirus.

The immunogenicity of BOOSTRIX [(containing valences, diphtheria (reduced dose), tetanus, pertussis) contained in BOOSTRIXTETRA] administered 10 years after a first booster dose of a vaccine at reduced doses of antigens diphtheria , Tetanus and acellular pertussis, was evaluated. One month after vaccination, 99% or more of the subjects were seroprotected against diphtheria and tetanus and seropositive against pertussis.


Pertussis antigens contained in BOOSTRIXTETRA are an integral part of acellular pertussis pediatric pertussis combined vaccines ("Infanrix®"), for which efficacy after primary vaccination has been demonstrated in a family effectiveness study. The antibody titers against the three pertussis components following BOOSTRIXTETRA vaccination are at least as high or higher than those observed in the family effectiveness study. Based on these comparisons, BOOSTRIXTETRA should provide protection against pertussis, however the degree and duration of protection offered by this vaccine are not known.

It is unlikely that the vaccine affects the ability to drive or use machinery

Hypersensitivity to the active substances or to any of the excipients mentioned in this section: Composition or to neomycin or to polymyxin

Previous hypersensitivity to a vaccine containing diphtheria, tetanus, pertussis or poliomyelitis.

BOOSTRIXTETRA should not be administered to subjects with an encephalopathy of unknown origin within 7 days, and administration of a vaccine containing pertussis-valence. >
Under these circumstances vaccination against pertussis should be stopped and the vaccination schedule should be continued with diphtheria, tetanus and poliomyelitis vaccines. >
BOOSTRIXTETRA should not be administered to subjects who have experienced transient thrombocytopenia or neurological complications (for convulsions or episodes of hypotonia-hyporeactivity, see section 4.4). A previous vaccination against diphtheria and / or tetanus.

As with other vaccines, vaccination with BOOSTRIXTETRA should be delayed in subjects with severe acute febrile infections. The presence of a benign infection is not a contraindication.

The vaccination must be preceded by a search for the medical history (in particular for previous vaccinations and undesirable events which may have occurred)

If the occurrence of any of the following events is chronologically related to the administration of a vaccine containing valency pertussis the decision to administer other doses of vaccines containing pertussis valency should be carefully evaluated < Code>
· Fever greater than or equal to 40 ° C within 48 hours without any other identifiable cause

Collapse or pseudo-shock syndrome (hypotonic-hyporesponsive syndrome) within 48 hours after vaccination

· Creep persistent, inconsolable for a period of time, greater than or equal to 3 hours, occurring within 48 hours after vaccination.
· Convulsions with or without fever occurring within 3 days after vaccination

There may be certain circumstances, in particular in the event of a high incidence of whooping cough, where the potential benefits of vaccination exceed the possible risks.

As for any vaccination, the benefit ratio is likely to result in a vaccination by BOOSTRIXTETRA or to report it in a child with a neurological disease, severe whether new or progressive, should be carefully evaluated. >

As with all injectable vaccines, it is recommended to always have appropriate medical treatment and surveillance for the rare case of an anaphylactic reaction following the administration of the vaccine.

BOOSTRIXTETRA should be administered with caution in subjects with thrombocytopenia (see section 4.3) or a coagulation disorder because of the risk of bleeding which may occur during intramuscular administration. A firm pressure shall be exerted at the injection site (without rubbing) for at least 2 minutes.
BOOSTRIXTETRA should under no circumstances be administered intravascularly.

A personal or family history of convulsions or a family history of adverse events following a diphtheria-tetanus-pertussis (DTP) vaccination are not contraindications.

Infection with the Human Immunodeficiency Virus (HIV) is not considered a contraindication. The expected immune response may not be obtained after vaccination in immunocompromised patients

Syncope (fainting) may occur after any vaccination, and even before, especially in adolescents, as a psychogenic response to injection with a needle. This can be accompanied by several neurological signs such as a transient disorder of vision, paresthesias and movements, tonic-clonic limbs during the recovery phase. It is important that measures be put in place to prevent injuries in case of fainting.
Use with other vaccines or immunoglobulins

BOOSTRIXTETRA may be administered simultaneously with the human papillomavirus vaccine without clinically significant interference on the immune response of each of the vaccines regardless of the valency.
The simultaneous administration of BOOSTRIXTETRA and other vaccines or with immunoglobulins has not been specifically studied

BOOSTRIXTETRA is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis in subjects from the age of 4 years (see section 4.2). The administration of BOOSTRIXTETRA should be based on official recommendations

Co-administration is unlikely to interfere with immune responses

If simultaneous administration of BOOSTRIXTETRA with other vaccines or immunoglobulins is required, the products should be injected at separate injection sites in accordance with the recommendations in force. >

Use with treatment, immunosuppressant

As with any vaccine, subjects receiving immunosuppressive therapy may not have a satisfactory immune response.

In the absence of compatibility studies, this vaccine should not be mixed with other medicines.


Pregnancy

Studies in animals have shown no direct or indirect deleterious effect on pregnancy, embryonal or fetal development, parturition or postnatal development (see section Preclinical safety data ).

As with other inactivated vaccines, BOOSTRIXTETRA vaccination is not expected to be deleterious to the fetus.
No teratogenic effects were observed following the administration of vaccines containing diphtheria or tetanus toxoids or poliomyelitis virus inactivated to pregnant women
>
Breastfeeding

The effect of BOOSTRIXTETRA administration during breastfeeding has not been evaluated. Nevertheless, since BOOSTRIXTETRA contains toxoids and inactivated antigens, no risk to the breastfed child should be expected. Benefits compared to risk: administer BOOSTRIXTETRA to women who are breast-feeding should be evaluated by health professionals.

Fertility

No data from prospective studies in humans are available. Studies in animals have not revealed any direct or indirect deleterious effect on the fertility of females (see section on safety data, preclinical data).
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Tolerance profile summary

The safety profile presented below is based on data from clinical trials in which BOOSTRIXTETRA was administered to 908 children (ages 4 to 8 years) and 955 adults, adolescents, and children (10 years of age) At 93 years of age.
The most commonly reported adverse reactions in the two groups after administration of BOOSTRIXTETRA were injection site reactions (pain, redness, and swelling) in 31.3% to 82.3% Of the subjects. These effects occurred, usually within 48 hours of vaccination and resolved without sequelae.

List of undesirable effects

The reported adverse reactions are listed according to the following frequencies

Very common (≥; 1/10)

Frequency (≥ 1/100 and;
In addition, the following adverse reactions have been reported in clinical trials with another GlaxoSmithKline Biologicals vaccine containing diphtheria, tetanus, pertussis, and acellular antigens (BOOSTRIX) antigens. BOOSTRIX was administered to 839 children (ages 4 to 8 years) and 1931 adults, adolescents and children (aged 10 to 76 years)

In subjects aged 4 to 8 years (N '= 839)
Infections and infestations

Uncommon: upper respiratory tract infection

Disorders of the nervous system

Uncommon: attention disorders

Disorders of the eye

Uncommon, conjunctivitis

Gastrointestinal disorders

Common: disorders, gastrointestinal.

Skin and subcutaneous tissue disorders

Uncommon: rash, skin.
Disorders, General and Site Anomalies, Administration

Uncommon: pain.
Subjects aged 10 to 76 years (N '= 1931)

Infections and infestations

Uncommon: upper respiratory tract infection, pharyngitis.

Disorders of the nervous system

Uncommon: syncope.

Respiratory, thoracic and mediastinal disorders

Uncommon: cough.

Gastrointestinal disorders

Uncommon, diarrhea

Skin and subcutaneous tissue disorders

Uncommon: hyperhidrosis, skin rash

Musculoskeletal and connective tissue disorders

Uncommon: stiffness, musculoskeletal and joints.

Disorders, General and Site Anomalies, Administration

Very common: malaise.

Common: Injection site reaction (such as site nodule, injection site and injection site sterile abscess)

Uncommon: syndrome, flu-like.
· Post-Marketing Surveillance

Since these events have been reported, it is not possible to estimate their frequency in a reliable manner.
Immune system disorders

Allergic reaction, including anaphylactic and anaphylactoid reactions.

Disorders of the nervous system

Episodes, hypotonia-hyporesponsiveness, seizures (with or without fever).

Skin and subcutaneous tissue disorders

Urticaria, Edema of Quincke.
Disorders, General and Site Anomalies, Administration

Asthenia.

Data suggests that in children receiving DTP (diphtheria-tetanus-pertussis) vaccination in childhood, a booster dose may lead to an increase in local reactogenicity.

Following administration of vaccines containing tetanus toxoid, very rare cases of adverse effects in the central and peripheral nervous system, including ascending paralysis or even paralysis, respiratory diseases (eg Guillain-Barré syndrome), Have been reported.

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers -