Boostrix Polio

Boostrix Polio

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Combined diphtheria, tetanus, acellular pertussis and enhanced inactivated polio vaccine.
Description
Each dose (0.5 mL) of vaccine contains diphtheria toxoid* not less than 2 IU [2.5 limit of flocculation (Lf)], tetanus toxoid* not less than 20 IU (5 Lf), Bordetella pertussis antigens (pertussis toxoid* 8 mcg, filamentous haemagglutinin* 8 mcg, pertactin* 2.5 mcg), inactivated polio virus [type 1 (Mahoney strain)** 40 D-antigen units, type 2 (MEF-1 strain)** 8 D-antigen units, type 3 (Saukett strain)** 32 D-antigen units].
*Adsorbed on aluminium hydroxide, hydrated [Al(OH)3] 0.3 mg Al3+ and aluminium phosphate (AlPO4) 0.2 mg Al3+.
**Propagated in VERO cells.
Boostrix Polio also contains the following excipients: Medium 199 (as stabilizer), sodium chloride, water for injections, formaldehyde, polysorbate 80, neomycin sulfate, polymyxin B sulfate are present as residuals from manufacturing process.
Action
Pharmacotherapeutic Group: Combined bacterial and viral vaccines. ATC Code: J07CA02.
Pharmacology: Pharmacodynamics: One month post-vaccination with Boostrix Polio, immune responses in 1469 subjects were stated in the table. (See table.)

Click on icon to see table/diagram/image

As with other adult-type Td vaccines, Boostrix Polio induces higher seroprotection rates and higher titres of both anti-D and anti-T antibodies in children and adolescents as compared to adults.
The pertussis antigens contained in Boostrix Polio are an integral part of the paediatric acellular pertussis combination vaccine (Infanrix), for which efficacy after primary vaccination has been demonstrated in a household contact efficacy study. The antibody titres to all 3 pertussis components following vaccination with Boostrix Polio are at least as high or higher than those observed during the household contact efficacy trial. Based on these comparisons, Boostrix Polio would provide protection against pertussis, however, the degree and duration of protection afforded by the vaccine are undetermined.
Five (5) years following vaccination with Boostrix Polio, at least 97% of children from the age of 4 years onwards were seroprotected or seropositive against all vaccine components, except for the pertussis toxoid component (41% of subjects were seropositive against pertussis toxoid).
Ten (10) years following vaccination with Boostrix (DTPa component of Boostrix Polio), at least 86% of adults were seroprotected or seropositive against all vaccine components.
In adolescents, the percentage of subjects who were seroprotected or seropositive was at least 82% against all vaccine components, except for the pertussis toxoid component (61% of subjects were seropositive against pertussis toxoid).
The immunogenicity of Boostix Polio, administered 5 years after a previous booster dose of Boostrix Polio at 4-8 years of age, has been evaluated. One (1) month post-vaccination, >99% of subjects were seropositive against pertussis and seroprotected against diphtheria, tetanus and all 3 polio types.
The immunogenicity of Boostrix (DTPa component of Boostrix Polio), administered 10 years after a previous booster dose with a reduced-antigen content diphtheria, tetanus and acellular pertussis vaccine has been evaluated. One (1) month post-vaccination, >99% of subjects were seroprotected against diphtheria and tetanus, and seropositive against pertussis.
In subjects ≥40 years that had not received any diphtheria or tetanus-containing vaccine in the past 20 years (including those who have never been vaccinated or whose vaccination status was unknown), 1 dose of Boostrix Polio induced an antibody response against pertussis and protected against tetanus and diphtheria in the majority of cases. Two (2) additional doses of diphtheria and tetanus-containing vaccine maximized the vaccine response against diphtheria and tetanus when administered 1 and 6 months after the 1st dose.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies of safety and toxicity.
Indications/Uses
Booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of 4 years onwards.
Boostrix Polio is not intended for primary immunization.
Dosage/Direction for Use
A single 0.5-mL dose of the vaccine is recommended.
Boostrix Polio may be administered to patients from the age of 4 years onwards. It should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that provide low (adult) dose diphtheria toxoid plus tetanus toxoid in combination with pertussis and poliomyelitis antigens.
Boostrix Polio can be used in the management of tetanus-prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.
Repeat vaccination against diphtheria, tetanus, pertussis and poliomyelitis should be performed at intervals as per official recommendations (generally 10 years).
Administration: Boostrix Polio is for deep IM injection, preferably in the deltoid region (see also Precautions).
Overdosage
Cases of overdose have been reported during post-marketing surveillance. Adverse events following overdosage, when reported, were similar to those reported with normal vaccine administration.
Contraindications
Boostrix Polio should not be administered to subjects with known hypersensitivity to any component of the vaccine (see Description) or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or poliomyelitis vaccines.
Boostrix Polio is contraindicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus and poliomyelitis vaccines.
Boostrix Polio should not be administered to subjects who have experienced neurological complications following an earlier immunization against diphtheria and/or tetanus (for convulsions or hypotonic-hyporesponsive episodes, see Precautions).
Special Precautions
It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
As with other vaccines, administration of Boostrix Polio should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.
If any of the following events have occurred in temporal relation to receipt of pertussis-containing vaccine in infancy, the decision to give subsequent doses of pertussis-containing vaccines should be carefully considered: Temperature of 40°C and above (rectal) within 48 hrs of vaccination, not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hrs of vaccination; persistent, inconsolable crying lasting ≥3 hrs, occurring within 48 hrs of vaccination; convulsions with or without fever, occurring within 3 days of vaccination.
There may be circumstances eg, a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since these events are not associated with permanent sequelae. According to available clinical data, the risk of such reactions is lower with acellular pertussis vaccines than with whole cell pertussis vaccines.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunization until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
Boostrix Polio should, in no circumstances, be administered intravascularly.
Boostrix Polio should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an IM administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least 2 min.
Collapse or shock-like state (hypotonic-hyporesponsive episode) and convulsions have been reported very rarely following immunization of children with products containing one or more of the antigenic constituents of Boostrix Polio.
A history of febrile convulsions, a family history of convulsions, sudden infant death syndrome (SIDS) and a family history of an adverse event following DTP vaccination do not constitute contraindications.
Human immunodeficiency virus (HIV) infection is not considered as a contraindication.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients eg, patients on immunosuppressive therapy.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Effects on the Ability to Drive or Operate Machinery: Boostrix Polio is unlikely to produce an effect on the ability to drive and use machines.
Use in Pregnancy: Human data on the use of Boostrix Polio during pregnancy are not available. However, animal studies showed no reproductive toxicity or teratogenic effects.
As with other inactivated vaccines, it is not expected that vaccination with Boostrix Polio harms the foetus. However, the vaccine should be used during pregnancy only when clearly needed and the possible advantages outweigh the possible risks for the foetus.
Use in Lactation: The safety of Boostrix Polio when administered to breastfeeding women has not been evaluated.
It is unknown whether Boostrix Polio is excreted in human breast milk.
Boostrix Polio should only be used during breastfeeding when the possible advantages outweigh the potential risks.
Use In Pregnancy & Lactation
Use in Pregnancy: Human data on the use of Boostrix Polio during pregnancy are not available. However, animal studies showed no reproductive toxicity or teratogenic effects.
As with other inactivated vaccines, it is not expected that vaccination with Boostrix Polio harms the foetus. However, the vaccine should be used during pregnancy only when clearly needed and the possible advantages outweigh the possible risks for the foetus.
Use in Lactation: The safety of Boostrix Polio when administered to breastfeeding women has not been evaluated.
It is unknown whether Boostrix Polio is excreted in human breast milk.
Boostrix Polio should only be used during breastfeeding when the possible advantages outweigh the potential risks.
Adverse Reactions
Clinical Trials Data: The safety profile presented as follows is based on data from clinical trials where Boostrix Polio was administered to 908 children (4-9 years) and 955 adults, adolescents and children (>10 years).
The most common events occurring after vaccine administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3-82.3% of subjects overall. These had their onset within the 1st day after vaccination. All resolved without sequelae.
Adverse reactions reported are listed according to the following frequency: Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000).
Children 4-9 years: Blood and Lymphatic System Disorders: Uncommon: Lymphadenopathy.
Metabolism and Nutrition Disorders: Common: Anorexia.
Psychiatric Disorders: Common: Irritability. Uncommon: Sleep disorder, apathy.
Nervous System Disorders: Very Common: Somnolence. Common: Headache.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dry throat.
Gastrointestinal Disorders: Uncommon: Diarrhoea, vomiting, abdominal pain, nausea.
General Disorders and Administration Site Conditions: Very Common: Injection site reactions (including pain, redness and swelling). Common: Fever 37.5°C and above (including fever above 39°C), injection site reactions (eg, haemorrhage). Uncommon: Fatigue.
Adults, Adolescents and Children From the Age of 10 years Onwards: Infections and Infestations: Uncommon: Oral herpes.
Blood and Lymphatic System Disorders: Uncommon: Lymphadenopathy.
Metabolism and Nutrition Disorders: Uncommon: Decreased appetite.
Nervous System Disorders: Very Common: Headache. Uncommon: Paraesthesia, somnolence, dizziness.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Asthma.
Gastrointestinal Disorders: Common: Gastrointestinal disorders.
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Myalgia, arthralgia.
General Disorders and Administration Site Conditions: Very Common: Injection site reactions (including pain, redness and swelling), fatigue. Common: Fever 37.5°C and above, injection site reactions (eg, haematoma). Uncommon: Fever above 39°C, chills, pain.
The following adverse reactions were additionally reported during clinical trials with GlaxoSmithKline's other reduced-antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix) where Boostrix was administered to 839 children (4-9 years) and 1931 adults, adolescents and children (>10 years): Children 4-9 years: Infections and Infestations: Uncommon: Upper respiratory tract infection.
Nervous System Disorders: Uncommon: Disturbances in attention.
Eye Disorders: Uncommon: Conjunctivitis.
Gastrointestinal Disorders: Common: Gastrointestinal disorders.
Skin and Subcutaneous Tissue Disorders: Uncommon: Rash.
General Disorders and Administration Site Conditions: Uncommon: Injection site reactions (eg, induration), pain.
Adults, Adolescents and Children From the Age of 10 years Onwards: Infections and Infestations: Uncommon: Upper respiratory tract infection, pharyngitis.
Nervous System Disorders: Uncommon: Syncope.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Cough.
Gastrointestinal Disorders: Common: Nausea. Uncommon: Diarrhoea, Vomiting.
Skin and Subcutaneous Tissue Disorders: Uncommon: Hyperhidrosis, rash.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Joint stiffness, musculoskeletal stiffness.
General Disorders and Administration Site Conditions: Very Common: Malaise. Common: Injection site reactions (eg, injection site mass and injection site abscess sterile). Uncommon: Influenza-like illness.
Subjects fully primed with 4 doses of DTPa followed by Boostrix Polio at around 4-8 years of age show no increased reactogenicity after the 2nd Boostrix Polio dose administered 5 years later.
Subjects fully primed with 4 doses of DTPw followed by a Boostrix dose around 10 years of age show an increase of local reactogenicity after an additional Boostrix dose administered 10 years later.
Post-Marketing Data: The following adverse reactions were reported during post-marketing surveillance after vaccination with Boostrix Polio: Immune System Disorders: Very Rare: Allergic reactions, including anaphylactic and anaphylactoid reactions.
General Disorders and Administration Site Conditions: Rare: Injection site induration.
The following adverse reactions were additionally reported during post-marketing surveillance after vaccination with GlaxoSmithKline's other reduced-antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix): Blood and Lymphatic System Disorders: Rare: Angioedema.
Nervous System Disorders: Rare: Convulsions (with or without fever).
Skin and Subcutaneous Tissue Disorders: Rare: Urticaria.
General Disorders and Administration Site Conditions: Rare: Extensive swelling of the vaccinated limb, asthenia.
Drug Interactions
Concomitant use with other inactivated vaccines and with immunoglobulin is unlikely to result in interference with the immune responses.
When considered necessary, Boostrix Polio can be given concomitantly with other vaccines or immunoglobulins.
If Boostrix Polio is to be given at the same time as another injectable vaccine or immunoglobulin, the products should always be given at different sites.
As with other vaccines, it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate immunologic response may not be achieved.
Incompatibilities: Boostrix Polio should not be mixed with other vaccines in the same syringe.
Caution For Usage
Instructions for Use and Handling: Prior to use, Boostrix Polio should be at room temperature and well shaken in order to obtain a homogeneous turbid white suspension. Prior to administration, Boostrix Polio should be visually inspected for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the vaccine.
Upon removal from refrigerator, Boostrix Polio is stable for 8 hrs at +21°C.
Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
Store at +2 to +8°C. Do not freeze. Discard if Boostrix Polio has been frozen.
ATC Classification
J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Pre-filled syringe (turbid white susp) 0.5 mL x 1's.
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