What are the Tetanus Vaccines?

Tetanus

There are several anti-tetanus vaccines authorized by the Italian Medicines Agency (AIFA) and they differ above all in their single-component or multivalent formulation.

The DTaP vaccine (when and if available), intended for children from 6 weeks to 7 years, contains the Bordetella pertussis antigen, the toxoid Corynebacterium diphtheriae and Clostridium tetani (in Tripedia they were kept in culture «in a peptone-based medium containing extract
bovine»6); until a few years ago, it also contained mercury salts, which were later eliminated. Trivalent products still authorized but difficult to find on the market may contain aluminum hydroxide, formaldehyde and polysorbate 80.

Monocomponent vaccines

Anatetall - GlaxoSmithKline (click to open)

Imovax Tetanus - Sanofi Pasteur (click to open)

DTP vaccines (Diphtheria, Tetanus, Pertussis)

Boostrix - GlaxoSmithKline (click to open)

Diphtheria, tetanic and pertussis acellular vaccine (adsorbed)
Boostrix is a vaccine used as a booster dose in children 4 years of age and older, adolescents and adults for the prevention of diphtheria, tetanus and acellular (adsorbed) pertussis-

Dosage declared by the manufacturer

Boostrix can be given from the age of four onwards. It is also given to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of a vaccination course against the three diseases.
The manufacturer recommends two additional doses of a diphtheria-tetanus-containing vaccine, one and six months apart from the first dose to maximize the diphtheria-tetanus vaccine response.

Pediatric population: The safety and efficacy of Boostrix in children aged less than 4 years have not been established.

Adverse events declared by the manufacturer

upper respiratory tract infection
pharyngitis
lymphadenopathy
anorexia
irritability
drowsiness
headache
dizziness
attention disorders
syncope
conjunctivitis
cough
Diarrhea
vomiting
gastrointestinal disorders
nausea
rash
hyperhidrosis
pruritus
arthralgia
myalgia
joint stiffness
musculoskeletal stiffness
injection site reactions (such as redness and/or swelling),
pain at the injection site
fatigue
malaise
fatigue
pyrexia (fever ≥ 37,5°C including fever > 39,0°C)
extensive swelling of the vaccinated limb (sometimes involving the adjacent joint)
injection site reactions (such as injection site mass and sterile injection site abscess)
other injection site reactions (such as induration)
flu-like illness
increased local reactogenicity in booster dose recipients following childhood vaccination
allergic reactions, including anaphylactic reactions and anaphylactoid reactions
hypotonic-hyporesponsive episodes, seizures (with or without fever)
urticaria, angioedema
asthenia
central or peripheral nervous system adverse reactions, including ascending paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome).

Qualitative composition declared by the manufacturer

Diphtheria toxoid adsorbed on aluminum hydroxide, hydrate (Al(OH)3)
Tetanus toxoid adsorbed on aluminum hydroxide, hydrate (Al(OH)3)
Bordetella pertussis antigens: pertussis toxoid, filamentous hemagglutinin, pertactin
aluminum phosphate (AlPO4)
Sodium chloride
Water for injections

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Infanrix - GlaxoSmithKline (click to open)

Triaxis - Sanofi Pasteur MSD (click to open)

Tribaccine - AJ Vaccines (click to open)

Hexavalent vaccines (Tetanus, Diphtheria, Pertussis, Hepatitis B, Poliomyelitis and Haemophilus influenzae type b)

Hexyon - Sanofi Pasteur MSD (click to open)

Hexyon (Diphtheria Tetanus Pertussis (DTaP), Poliomyelitis (IPV), Hepatitis B (HB), Haemophilus influenzae type b (Hib) is indicated for the primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria , tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.

Dosage declared by the manufacturer

The primary vaccination consists of 2 or 3, to which a booster dose is added. Hexyon comes given to children from six weeks of age elsafe for children over the age of 24 months it has not been studied in clinical trials.

Adverse events declared by the manufacturer

Hypersensitivity reactions
Anaphylactic reaction*
Inappetence (decreased appetite)
Crying, drowsiness
Abnormal crying (prolonged)
Seizures with or without fever*
Hypotonic reactions or episodes of hypotonia-hyporesponsiveness (HHE)
Threw up
Diarrhea
Raro Skin rash
Injection site pain, injection site erythema injection, swelling at the injection site
Irritability
Pyrexia (body temperature ≥ 38,0°C)
Induration at the injection site
Injection site lump
Pyrexia (body temperature ≥ 39,6°C)
Extensive swelling of the limbs
Brachial neuritis and Guillain-Barré syndrome
Peripheral neuropathy, optic neuritis e central nervous system demyelination (multiple sclerosis)
Apnea in very preterm infants (≤ 28 weeks gestation)
Roedematous actions involving one or both lower limbs

Qualitative composition declared by the manufacturer

Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigens
Pertussis toxoid
Filamentous hemagglutinin
Poliovirus produced on Vero cells
- Type 1 (Mahoney)
- Type 2 (MEF-1)
- Type 3 (Saukett)
Hepatitis B surface antigen produced in Hansenula polymorpha yeast cells by recombinant DNA technology
Polysaccharide of Haemophilus influenzae type b
aluminum hydroxide, hydrate
glutaraldehyde,
formaldehyde,
neomycin,
streptomycin and polymyxin B
Excipient with known effect
Phenylalanine
Dibasic sodium phosphate
Potassium dihydrogen phosphate
Trometamol
Sucrose
Essential amino acids including L-phenylalanine
Sodium hydroxide, acetic acid or hydrochloric acid

Curiosity

On 29 July 2017, two days before the publication in the Official Gazette of the so-called Lorenzin Decree, the Italian Medicines Agency (AIFA) updated the texts of the summary of product characteristics (Rcp) and the package leaflet (Fi) of the vaccine Hexyon. The SPC published by AIFA before 29 July 2017 reported in paragraph 4.8 that "The safety of Hexyon in children older than 24 months has not been studied in clinical trials" and in paragraph 5.1 that "The immunogenicity of Hexyon in children older than 24 months has not been studied in clinical trials." On 29 July 2017 the prescription of 24 months of age disappeared, thus guaranteeing the possibility of administering that vaccine in accordance with the political needs dictated and regulated by the Lorenzin Decree. The same change was also found on the same day on the European Medicines Agency (EMA) website.
Since that torrid July 2017, our questions have remained unanswered: which studies have been presented in order to guarantee safety and efficacy after 24 months of age?

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Infanrix Hexa - GlaxoSmithKline (click to open)

Diphtheria (D), Tetanus (T), Pertussis (acellular component) (Pa), Hepatitis B (rDNA) (HBV), Polio (inactivated) (IPV), and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed) and is indicated for primary and booster vaccination of infants and young children

Dosage declared by the manufacturer

The primary immunization schedule consists of two or three doses which should be administered based on official recommendations.
The safety and efficacy of Infanrix hexa in children older than 36 months have not been established. No data available.

Adverse events declared by the manufacturer

Upper respiratory tract infection
Lymphadenopathy
Thrombocytopenia
Anaphylactic reactions
Anaphylactoid reactions (including urticaria)
Allergic reactions (including itching)
Loss of appetite
Abnormal crying, irritability, restlessness
Nervousness
Drowsiness
Collapse or shock-like state (hypotonic-hyporesponsive episode) 2
Seizures (with or without fever)
Tosse
Bronchitis
Freediving
Diarrhea
Threw up
Rash
angioedema
Dermatitis
Fever ≥ 38°C
Pain
Redness
Injection site swelling (≤ 50 mm)
Fever >39,5°C
Injection site reactions, including induration, local swelling at the injection site
Diffuse swelling of the injected limb, sometimes extending to the adjacent joint
Fatigue
Swelling of the entire injected limb
Extensive swelling reactions
Injection site mass
Blisters at the injection site
Paralysis
Neuropathy
Neuritis
Hypotension
Vasculitis
lichen planus
erythema multiforme
Arthritis
Muscle weakness
Guillain-Barre syndrome
encephalopathy
Encephalitis
Meningitis

Qualitative composition declared by the manufacturer

Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigens: Pertussis toxoid
Filamentous hemagglutinin
Pertactin
Hepatitis B surface antigen (HBs)
Polio virus (inactivated) (IPV): type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)
Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate, PRP)
Adsorbed on aluminum hydroxide, hydrate (Al(OH)3) produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Adsorbed on aluminum phosphate (AlPO4) propagated in VERO cells
Formaldehyde
Neomycin
Polymyxin
Para-aminobenzoic acid
Phenylalanine
Hib Powder: Anhydrous lactose
Sodium chloride
medium 199
mineral salts (including sodium and potassium)
vitamins (including para-aminobenzoic acid) and other substances
Water for injections

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Vaxelis - MCM Vaccine BV (click to open)

DTP+Polio vaccines (Diphtheria, Tetanus, Pertussis and Polio)

PolioBoostrix - GlaxoSmithKline (click to open)

Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine (adsorbed, antigen-reduced). PolioBoostrix is a vaccine used as a booster dose in children 3 years of age and older, adolescents and adults

Dosage declared by the manufacturer

Administration of a single dose followed by two additional doses of a diphtheria-tetanus containing vaccine, one and six months apart after the first dose to maximize vaccine response.

Adverse events declared by the manufacturer

Oral herpes
Lymphadenopathy
Anorexia
Decreased appetite
Irritability
Sleep disorder
Apathy
Drowsiness
Headache
Paraesthesia
Dizziness
Dry throat
Asthma
Gastrointestinal disturbances (such as vomiting, abdominal pain, nausea)
Diarrhea
itch
Arthralgia
Myalgia
Injection site reactions (such as redness and/or swelling)
Pain at the injection site
Fatigue
Pyrexia (fever ≥ 37,5°C including fever >39,0°C),
Extensive swelling of the vaccinated limb (sometimes involving the adjacent joint),
Injection site reactions (such as bleeding, itching, and induration)
Injection site reactions (such as bruising, itching, induration and numbness with a warm sensation)
Chills
Pain
Rash
Upper respiratory tract infection, pharyngitis
Attention disturbances
Syncope
Conjunctivitis
Tosse
Diarrhea
Hyperhidrosis, Rash
Joint stiffness, musculoskeletal stiffness
Malaise
Injection site reactions (such as injection site mass and sterile injection site abscess)
Influenza-like illness
Increased local reactogenicity
Allergic reactions, including anaphylactic reactions and anaphylactoid reactions
Hypotonic-hyporesponsive episodes, seizures (with or without fever)
Urticaria, angioedema
Asthenia

Qualitative composition declared by the manufacturer

Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigens: Pertussis toxoid, Filamentous hemagglutinin, Pertactin
Inactivated polio viruses: type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)
adsorbed on aluminum hydroxide, hydrate (Al(OH)3)
Aluminum phosphate (AlPO4) propagated in VERO cells
Medium 199 (as a stabilizer containing amino acids, mineral salts, vitamins and other substances)
Sodium chloride
Water for injections

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Polio Infanrix - GlaxoSmithKline (click to open)

Tetravac - Sanofi Pasteur MSD (click to open)

Adsorbed antidipteric, tetanus, pertussis (acellular component) and polio (inactivated) vaccine
It is given as a primary course of vaccination in infants and young children and as a booster vaccination in children who have previously received this vaccine or a similar vaccine.

Dosage declared by the manufacturer

The primary immunization can be carried out by starting the vaccination at the age of two or three months, administering 3 doses with an interval of 1 or 2 months between one administration and the next or it can be carried out starting from the third month of life by administering 2 doses with an interval of 2 months between one and the other, followed by a third dose at the 12th month of life. The primary cycle is followed by a fourth booster dose within the second year of life.

Tetravac contains a high dose of the diphtheria component. However, in some countries, in accordance with local vaccination policies, the use of vaccines containing a low dose of the diphtheria component in subjects under the age of 13 may be recommended.

Adverse events declared by the manufacturer

Lymphadenopathy
Anaphylactic reactions such as face oedema, Quincke's oedema.
Anorexia
Nervousness (irritability)
Abnormal crying
Insomnia (sleep disturbances)
Prolonged inconsolable crying
Drowsiness (torpor)
Headache
Seizures with or without fever
Syncope
Threw up
Diarrhea
Myalgia
Allergy-like symptoms, such as rash of various types, erythema and urticaria
Redness at the injection site
Pain at the injection site
Swelling at the injection site
Pyrexia (fever) ≥ 38°C
Malaise
Induration at the injection site
Redness and edema ≥ 5 cm at the injection site
Pyrexia (fever) ≥ 39°C
Pyrexia > 40°C (high fever)
Large reactions at the injection site (> 50 mm), including extensive swelling of the limb, from the injection site beyond one or both joints
Erythema, warmth, tenderness or pain at the injection site
Oedematous reaction affecting one or both lower limbs
cyanosis
Redness
Transient purpura and high-pitched cry
Brachial neuritis
Guillain-Barre syndrome
Freediving

Qualitative composition declared by the manufacturer

Purified diphtheria toxoid
Purified tetanus toxoid
Purified pertussis toxoid
Purified filamentous hemagglutinin
Inactivated polio virus type 15
Inactivated polio virus type 25 Produced on Vero cells
Inactivated polio virus type 35
Adsorbed on hydrated aluminum hydroxide
Glutaraldehyde
Neomycin
Streptomycin
Polymyxin B
Phenylalanine
Formaldehyde
Phenoxyethanol
Anhydrous ethanol
Medium 199 Hanks without Phenol Red [complex blend of amino acids (including phenylalanine), salts
minerals, vitamins and other substances (such as glucose)]
Glacial acetic acid and/or sodium hydroxide
Water for injections

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Triaxis Polio - Sanofi Pasteur (click to open)

IMPORTANT NOTE: Corvelva invites you to get in-depth information by reading all the sections and links, as well as the manufacturer's product leaflets and technical data sheets, and to speak with one or more trusted professionals before deciding to vaccinate yourself or your child. This information is for informational purposes only and is not intended as medical advice.

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