Infanrix-IPV

Infanrix-IPV

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Combined diphtheria-tetanus-acellular pertussis (DTPa) and inactivated polio.
Description
Each 0.5-mL dose of vaccine contains adsorbed diphtheria toxoid not less than 25 Lf (approximately minimum 30 IU), adsorbed tetanus toxoid not less than 10 Lf (approximately minimum 40 IU), 3 purified pertussis antigens adsorbed on aluminium salts [pertussis toxoid (PT) 25 mcg, filamentous hemagglutinin (FHA) 25 mcg and pertactin (PRN/69 kiloDalton outer membrane protein) 8 mcg], 3 types of inactivated polio viruses [type 1 (Mahoney strain) 40 D antigen units, type 2 (MEF-1 strain) 8 D antigen units and type 3 (Saukett strain) 32 D antigen units].
Infanrix-IPV also contains the following excipients: Sodium chloride, aluminium salts, medium 199 (as stabilizer), water for injections. Potassium chloride, disodium phosphate, monopotassium phosphate, polysorbate 80, glycine, formaldehyde, neomycin sulfate, polymyxin sulfate are present as residuals from the manufacturing process.
The diphtheria and tetanus toxoids obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani are inactivated and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I Bordetella pertussis from which the PT, FHA and pertactin are extracted and purified. FHA and pertactin are treated with formaldehyde, PT is treated with glutaraldehyde and formaldehyde and irreversibly inactivated.
The 3 polioviruses are cultivated on a continuous VERO cell line, purified and inactivated with formaldehyde.
The DTPa-IPV components are formulated in saline.
Infanrix-IPV meets the World Health Organisation (WHO) requirements for the manufacture of biological substances, diphtheria, tetanus, pertussis and combined vaccines, and inactivated poliomyelitis vaccines.
Action
Pharmacotherapeutic Group: Combined bacterial and viral vaccines. ATC Code: J07CA02.
Pharmacology: Pharmacodynamics: Immune Response to the diphtheria toxoid (DT) Components: One month after a primary vaccination course, >99% of infants vaccinated with Infanrix-IPV had antibody titres of ≥0.1 IU/mL to both tetanus and diphtheria.
Following administration of a booster dose of Infanrix-IPV, >99.5% of children had antibody titres of ≥0.1 IU/mL for both antigens.
Immune Response to the acellular pertussis (Pa) Component: One month after the 3-dose primary vaccination course with Infanrix-IPV, 100% of infants were seropositive for the 3 pertussis components (PT, FHA and pertactin) and the overall response rates for each of the 3 individual pertussis antigens were ≥94%.
A booster response was seen in the vast majority of vaccinees against the pertussis antigens; lower response rates were seen in studies where the prevaccination levels of antibodies were high. All subjects were seropositive 1 month after this dose.
Protective Efficacy of the Pa Component: As the immune response to pertussis antigens following Infanrix-IPV administration is equivalent to that of Infanrix, it can be assumed that the protective efficacy of the 2 vaccines will also be equivalent.
The clinical protection of the DTPa component against WHO-defined typical pertussis (≥21 days of paroxysmal cough), was demonstrated in: A prospective blinded household contact study performed in Germany (3-, 4-, 5-month schedule). Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of the vaccine was 88.7%; a NIH-sponsored efficacy study performed in Italy (2-, 4-, 6-month schedule), the vaccine efficacy was found to be 84%. In a follow-up of the same cohort, the efficacy was confirmed for up to 4 years of age.
Immune Response to the IPV Component: One month after the primary vaccination, the overall seropositivity for each of the 3 serotypes (type 1, 2 and 3) was ≥99.5%.
Following administration of a booster dose of Infanrix-IPV, 100% of children were seropositive for the 3 serotypes.
In all booster trials, vaccination induced a marked increase in antibody levels with respect to pre-booster values.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical Safety Data: Not applicable.
Indications/Uses
For active immunisation in infants from the age of 2 months against diphtheria, tetanus, pertussis and poliomyelitis.
As a booster dose for children who have previously been immunised with DTP and polio antigens.
Dosage/Direction for Use
Dosage: The primary vaccination schedule consists of 3 doses in the 1st year of life and can start from the age of 2 months. An interval of at least 1 month should be respected between subsequent doses.
When the primary course is completed before the age of 6 months, a booster dose can be given in the 2nd year of life. An interval of at least 6 months after completion of primary vaccination schedule should be respected. Data on the use of the vaccine as a booster has been obtained for children up to 13 years.
Administration: Infanrix-IPV is for deep IM injection. For infants, the preferred site of injection is the anterolateral aspect of the thigh; in older children, vaccine should be administered in the deltoid.
It is preferable that each subsequent dose is given at alternate sites.
Infanrix-IPV 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.
Overdosage
Cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported, are not specific but similar to adverse events reported with normal vaccine administration.
Contraindications
Subjects with known hypersensitivity to any component of Infanrix-IPV or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or inactivated polio vaccines.
Infanrix-IPV is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.
Special Precautions
As with other vaccines, the administration of Infanrix-IPV should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
It is a 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.
If any of the following events occur in temporal relation to receipt of diphtheria-tetanus-pertussis (DTP)-containing vaccine, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. There may be circumstances eg, a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since the events are not associated with permanent sequelae. According to available clinical data, the risk-benefit ratio of Pa vaccine is better than the risk-benefit ratio of whole cell pertussis vaccine. The following events were previously considered contraindications for diphtheria-tetanus-whole cell pertussis (DTPw) and can now be considered precautions: Temperature of ≥40°C (rectal) within 48 hrs, 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.
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.
A history of febrile convulsions, a family history of convulsions, a family history of sudden infant death syndrome (SIDS) and a family history of an adverse event following DTP and/or IPV 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.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Infanrix-IPV contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics.
As with all diphtheria, tetanus and pertussis vaccines, Infanrix-IPV should be given deep IM.
Infanrix-IPV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an IM administration to these subjects.
Infanrix-IPV should under no circumstances be administered IV.
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.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use in pregnancy & lactation: Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Use in children: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hrs should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Use In Pregnancy & Lactation
Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Adverse Reactions
Clinical Trials Data: The safety profile presented as follows is based on data from >2200 subjects.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix-IPV with respect to the primary course.
Frequencies per dose are defined as follows: Very common: ≥10%; common: ≥1% and <10%; uncommon: ≥0.1% and <1%; rare: ≥0.01% and <0.1%; very rare: <0.01%.
Blood and Lymphatic System Disorders: Rare: Lymphadenopathy1.
Metabolism and Nutrition Disorders: Very Common: Loss of appetite.
Psychiatric Disorders: Very Common: Restlessness, abnormal crying, irritability.
Nervous System Disorders: Very Common: Headache1 (age range 6-13 years), somnolence.
Respiratory, Thoracic and Mediastinal Disorders: Rare: Bronchitis2, cough2.
Gastrointestinal Disorders: Common: Nausea1, vomiting, diarrhoea.
Skin and Subcutaneous Tissue Disorders: Uncommon: Allergic dermatitis. Rare: Urticaria, rash2,3.
General Disorders and Administration Site Conditions: Very Common: Injection site reactions eg, pain, redness, local swelling at the injection site (≤50 mm), fever ≥38°C. Common: Local swelling at the injection site (>50 mm)4, asthenia, malaise1, injection site reactions including induration. Uncommon: Diffuse swelling of the injected limb, sometimes involving the adjacent joint4, fever5 (>39.5°C).
Post-Marketing Data: Blood and Lymphatic System Disorders: Thrombocytopenia6.
Immune System Disorders: Allergic reactions, including anaphylactic2 and anaphylactoid reactions.
Nervous System Disorders: Collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions (with or without fever) within 2-3 days of vaccination.
Respiratory Disorders: Apnoea2 (see Use in children under Precautions).
Skin and Subcutaneous Tissue Disorders: Pruritus, angioneurotic oedema2.
General Disorders and Administration Site Conditions: Swelling of the entire injected limb4, injection site vesicles.
1Reported only with booster vaccination.
2Reported with GlaxoSmithKline's DTPa-containing vaccines.
3Uncommonly reported with booster vaccination.
4Children primed with Pa vaccines are more likely to experience swelling reactions after booster vaccination in comparison with children primed with whole cell vaccines. Local swelling at the injection site (>50 mm) and diffuse swelling may be more frequent (very common and common, respectively) when the booster dose is administered between 4 and 6 years. These reactions resolve over an average of 4 days.
5Commonly reported with booster vaccination.
6Reported with diphtheria and tetanus vaccines.
Drug Interactions
It is current practice in paediatric vaccination to co-administer different vaccines during the same session, where injectable vaccines should always be given at different injection sites.
Infanrix-IPV can be administered concomitantly with hepatitis B vaccine, and/or Haemophilus influenzae vaccine the injections being applied at different injection sites. Routine simultaneous administration of Hib vaccine and hepatitis B vaccine may be given to children who are at the recommended age to receive these vaccines.
Although data on the concomitant administration of Infanrix-IPV and measles, mumps and rubella combined vaccine and varicella vaccine are not available, it is generally accepted that they may be given at the same time if separate injection sites are used.
As with other vaccines it may be expected that, in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved.
Incompatibilities: Infanrix-IPV should not be mixed with other vaccines in the same syringe.
Caution For Usage
Upon storage, a white deposit and clear supernatant can be observed.
Instructions for Use and Handling: Infanrix-IPV should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Since a white sediment may form during storage, Infanrix-IPV suspension should be well shaken.
Storage
Store at +2°C to +8°C. The DTPa-IPV vaccine should not be frozen. Discard if it 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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