What are the Tetanus Vaccines?
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.
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)
Tetanus vaccine prepared from purified tetanus toxin, heat-inactivated and formaldehyde. Aluminum hydroxide is subsequently added to the vaccine in order to increase its immunogenic power.
Dosage declared by the manufacturer
For children over 7 years of age and for adults it provides a basic cycle of three doses, at times 0, 1 month, 6-12 months and subsequent booster doses every 10 years.
Italian National Vaccination Prevention Plan (PNPV).
Basic cycle 3 doses in the first year of life and booster at 6 years.
Adverse events declared by the manufacturer
- Injection site pain
- swelling at the vaccination site
- hardening of the injection site
- general malaise
- Artralgia
- Injection site erythema
- Laringite
- Headache
- Thrombocytopenia
- Diarrhea, vomiting
- Injection site lymphadenopathy, injection site abscess
- Urticaria, Allergic reaction
- Metabolism and nutrition disorders
- Musculoskeletal and connective tissue disorders
- Guillain Barrè syndrome, somnolence, brachial plexus neuritis
- Apnea in very premature infants (≤ 28 weeks of gestation)
Qualitative composition declared by the manufacturer
- Purified tetanus anatoxin
- Sodium chloride
- adjuvant Alluminio idrossido
- Water for injections
- Formaldehyde
Imovax Tetanus - Sanofi Pasteur (click to open)
Tetanus vaccine, purified tetanus anatoxin and adsorbed on aluminum hydroxide.
Dosage declared by the manufacturer
Adults and children over 3 months of age in a course of three doses.
Italian National Vaccination Prevention Plan (PNPV).
Basic cycle 3 doses in the first year of life and booster at 6 years.
Adverse events declared by the manufacturer
- Lymphadenopathy
- Type I hypersensitivity reactions
- Headache, dizziness
- Hypotension
- Allergy-like symptoms, such as generalized itching, urticaria or rash
- Myalgia, arthralgia
- Transient pyrexia
- Brachial neuritis and Guillain Barrè syndrome
- Apnea in very premature babies
Qualitative composition declared by the manufacturer
- Tetanus anatoxin purifies
- adjuvant aluminum hydroxide, hydrate
- Acetic acid and or sodium hydroxide
- Buffer solution
- Sodium chloride
- Disodium phosphate dihydrate
- Potassium dihydrogen phosphate
- Hydrochloric acid and/or sodium hydroxide
- Water for injections
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
Infanrix - GlaxoSmithKline (click to open)
Diphtheria, tetanus and acellular pertussis vaccine (adsorbed).
INFANRIX is indicated for active immunoprophylaxis against the three diseases in children from the second month of life.
Dosage declared by the manufacturer
The primary course of vaccination consists of three doses:
- first dose: starting from the second month of life
- second dose: 4-8 weeks after the first
- third dose: in the first year of life.
The booster doses are foreseen around 18 months of life and between 4 and 6 years of age and can also be administered to children previously vaccinated with triple vaccines against diphtheria, tetanus, pertussis, in which the pertussis component was whole cell.
Adverse events declared by the manufacturer
- Lymphadenopathy
- loss of appetite
- irritability
- restlessness
- unusual cry
- drowsiness
- headache
- cough
- bronchitis
- gastrointestinal disturbances such as diarrhea and vomiting
- pruritus
- rash
- urticaria
- redness, local swelling at the injection site (≤50 mm)
- injection site reaction including induration
- fever ≥ 38,0°C
- pain
- fatigue
- fever ≥ 39,1°C
- widespread swelling of the injected limb, sometimes involving the adjacent joint
- thrombocytopenia
- allergic reactions, including anaphylactic and anaphylactoid reactions
- collapse or shock-like state (hypotonic-hyporesponsive episodes), convulsions (with or without fever) within 2, 3 days of vaccination
- apnea (see section 4.4 for apnea in very premature neonates (≤ 28 weeks' gestation)
- angioneurotic oedema, dermatitis
- swelling of the entire injected limb
- constipation
- reduced fluid intake
- Insomnia
- Pharyngitis, upper respiratory tract diseases, otitis media
Qualitative composition declared by the manufacturer
- diphtheria anatoxin
- tetanus anatoxin
- pertussis anatoxin
- filamentous hemagglutinin
- outer membrane protein 69 kDa
- adjuvant: adsorbed on aluminum hydroxide
- sodium chloride aluminum hydroxide
- Formaldehyde
- polysorbate 80
- water for injections
Triaxis - Sanofi Pasteur MSD (click to open)
Diphtheria, tetanus, pertussis (acellular components) vaccine (adsorbed, reduced antigenic content)
This vaccine is used to stimulate protection against the three diseases in children from four years of age, adolescents and adults following a complete primary course of vaccination
Dosage declared by the manufacturer
In adolescents and adults, TRIAXIS can be given as part of a series of vaccinations against pertussis and in most cases also against tetanus and diphtheria. An additional dose of diphtheria-tetanus (dT)-containing vaccine may be given one month later, followed by a 3rd dose of diphtheria- or dT-containing vaccine 6 months after the first dose, to optimize protection against disease. Triaxis can be used as a booster dose for vaccination against diphtheria, tetanus and pertussis at intervals of 5 to 10 years.
Adverse events declared by the manufacturer
- Anaphylactic reaction
- angioedema
- Edema
- Rash
- Hypotension
- Anorexia (decreased appetite)
- Headache
- Paraesthesia
- Hypoaesthesia
- Guillain-Barre syndrome
- Brachial neuritis
- Facial paralysis
- Convulsions
- Syncope
- Myelitis
- Myocarditis
- diarrhea
- Nausea
- Threw up
- Rash
- itch
- Urticaria
- Generalized pain or muscle weakness,
- Arthralgia or Swelling in the joints
- Myositis
- Fatigue/Asthenia
- Malaise
- Chills
- Pain at the injection site
- Injection site erythema
- Swelling at the injection site
- Pyrexia
- Chills,
- Axillary adenopathy
- Ecchymosis at the injection site
- Sterile abscess at the injection site
Qualitative composition declared by the manufacturer
- Diphtheria toxoid
- Tetanus toxoid
- Pertussis toxoid
- Filamentous hemagglutinin
- Pertactin
- Type 2 and 3 fimbriae
- Adsorbed on aluminum phosphate
- Formaldehyde
- Glutaraldehyde
- Phenoxyethanol
- Water for injections
Tribaccine - AJ Vaccines (click to open)
Tribaccine is used to vaccinate children (4 years or older), adolescents and adults as a booster dose
Dosage declared by the manufacturer
A single injection of a dose is recommended in all age groups
Booster vaccination of adults against tetanus and diphtheria is usually indicated at 10-year intervals. There is currently no scientific data that could form the basis for official recommendations for an optimal time interval between booster vaccinations with Tribaccine.
The safety and efficacy of Tribaccine in people over the age of 55 have not been studied. In immunosuppressed persons, the serological response may be impaired. Vaccination of persons undergoing immunosuppressive therapy can be performed, but may result in impaired serological response
Adverse events declared by the manufacturer
- Hypersensitivity, including anaphylactic reactions
- Headache
- Urticaria
- Myalgia
- Injection site pain
- Injection site pruritus
- Redness at the injection site
- Swelling at the injection site
- Fatigue
- Fever (≥ 38°C)
- irritability and malaise
- Injection site redness (≥ 5 cm)
- Injection site swelling (≥ 5 cm)
- Fever (> 40°C)
- Injection site granuloma
- Sterile abscess at the injection site
Qualitative composition declared by the manufacturer
- Diphtheria toxoid, purified
- Tetanus toxoid, purified
- Pertussis toxoid, purified
- Adsorbed on hydrated aluminum hydroxide (Al(OH)3)
- Formaldehyde
- Sodium chloride
- Sodium hydroxide
- Water for injections
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?
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)
- Cough
- 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
Vaxelis - MCM Vaccine BV (click to open)
Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), polio (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Dosage declared by the manufacturer
The primary vaccination consists of two or three doses, to be administered with an interval of at least 1 month between one dose and the next, and can be carried out starting from 6 weeks of age.
Adverse events declared by the manufacturer
- Rhinitis
- Lymphadenopathy
- Reduced appetite
- Increased appetite
- Sleep disorders including insomnia, restlessness
- Drowsiness
- Hypotonia
- Pallor
- Cough
- Threw up
- Diarrhea
- Abdominal pain
- Rash, hyperhidrosis
- Crying, irritability
- crisis (convulsions ) with or without fever
- status type episodes shock
- extensive swelling of the vaccinated limb
- Erythema at the injection site, pain in the injection, injection site swelling
- Pyrexia
- Injection site lividuria, injection site induration, injection site nodule
- Injection site rash, injection site warmth, tiredness
- Apnea in very preborn infantsripe (≤ 28 weeks gestation)
Qualitative composition declared by the manufacturer
- Diphtheria toxoid adsorbed on aluminum phosphate
- Tetanus toxoid adsorbed on aluminum phosphate
- Bordetella pertussis antigens adsorbed on aluminum phosphate
- Pertussis toxoid
- Filamentous hemagglutinin (FHA)
- Pertactin (PRN)
- Type 2 and 3 fimbriae (FIM)
- Hepatitis B surface antigen (HbsAg) adsorbed on amorphous aluminum hydroxyphosphate sulfate produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
- Poliovirus (Inactivated) produced in Vero cells
- Type 1 (Mahoney)
- Type 2 (MEF-1)
- Type 3 (Saukett)
- Polysaccharide of Haemophilus influenzae type b
- glutaraldehyde
- formaldehyde
- neomycin
- streptomycin, polymyxin B
- bovine serum albumin
- Sodium phosphate
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
- Cough
- 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
Polio Infanrix - GlaxoSmithKline (click to open)
Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine (adsorbed)
PolioInfanrix is a vaccine used as a booster dose to protect children against the four diseases and is indicated for children aged 16 months to 13 years inclusive. It is not intended for persons over 14 years of age.
Dosage declared by the manufacturer
This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis in individuals 16 months to 13 years of age including those who have previously received a primary course of immunization against these diseases.
Adverse events declared by the manufacturer
- Lymphadenopathy
- Drowsiness
- Headache
- Bronchitis, cough
- Diarrhea
- Threw up
- Nausea
- Allergic dermatitis
- Rash
- itch
- Urticaria
- Loss of appetite
- Fever ≥ 38,0°C
- Pain
- Redness and swelling at the injection site
- Fever > 39,5°C
- Malaise
- Injection site reaction including induration
- Asthenia
- Unusual crying, irritability, restlessness
- Extensive swelling of the injected limb
- Diffuse swelling in the injecting limb, sometimes involving the adjacent joint as well
- Thrombocytopenia
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) Convulsions (with or without fever) within 2 to 3 days of vaccination
- Freediving
- Angioneurotic edema
- Blisters at the injection site
- Allergic reactions, including anaphylactic¹ and anaphylactoid reactions
Qualitative composition declared by the manufacturer
- Diphtheria toxoid
- Tetanus toxoid
- Bordetella pertussis antigens: pertussis toxoid, filamentous hemagglutinin, pertactin
- VERO cell propagated (inactivated) polio viruses: type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)
- adsorbed on aluminum hydroxide, hydrate
- Sodium chloride
- Medium 199 (mainly containing amino acids, mineral salts, vitamins)
- Water for injections.
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
Triaxis Polio - Sanofi Pasteur (click to open)
Diphtheria, tetanus, pertussis (acellular components) and polio vaccine (inactivated) (adsorbed, reduced antigenic content)
Dosage declared by the manufacturer
In adolescents and adults with unknown or incomplete vaccination status against diphtheria or tetanus, one dose of TRIAXIS POLIO can be given as part of the vaccination series against pertussis and poliomyelitis and, in most cases, also against tetanus and diphtheria. An additional dose of a diphtheria-tetanus (dT)-containing vaccine may be given one month later, followed by a third dose of a diphtheria- or dT-containing vaccine 6 months after the first dose to optimize protection against disease
Adverse events declared by the manufacturer
- Lymphadenopathy
- Anaphylactic reactions, such as urticaria, face edema and dyspnoea
- Headache
- Convulsions
- Vessel vagal syncope
- Guillain Barré syndrome
- Facial paralysis
- Myelitis
- Brachial neuritis
- Transient paraesthesia / hypoesthesia of the vaccinated limb
- Dizziness
- Diarrhea
- Nausea
- Threw up
- Abdominal pain
- Rash
- Arthralgia / joint swelling
- Myalgia
- Pain in the vaccinated limb
- Fatigue/asthenia,
- Temperature
- Chills
- Pain at the injection site,
- Swelling at the injection site,
- Injection site erythema
- Irritability
- Dermatitis at the injection site
- Injection site bruising
- Itching at the injection site
- Malaise
- Pallor
- Extensive swelling of the limbs
- hardening of the injection site
Qualitative composition declared by the manufacturer
- Diphtheria toxoid
- Tetanus toxoid
- Pertussis antigens: Pertussis toxoid, Filamentous hemagglutinin, Pertactin, Fimbriae type 2 and 3
- Poliovirus (inactivated) Cultured on Vero cells:
- Inactivated polio virus type 1 (Mahoney)
- Inactivated polio virus type 2 (MEF1)
- Inactivated polio virus type 3 (Saukett)
- Adsorbed on aluminum phosphate
- Formaldehyde,
- Glutaraldehyde
- Streptomycin
- neomycin,
- Polymyxin B
- Bovine serum albumin
