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Drug Details

PEDIACEL

• Drug Class Description
  Vaccines
• Generic Name
  Diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed)
• Presentation
  Suspension for Injectionin a vial Diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).
• Description
  Each 0.5 millilitre dose contains: Purified diphtheria toxoid…………not less than 30 international units* (15 Lf) Purified tetanus toxoid…………….not less than 40 international units* (5 Lf) Purified pertussis toxoid (PT)……………………20 micrograms Purified filamentous haemagglutinin (FHA)…….20 micrograms Purified fimbrial agglutinogens 2 and 3 (FIM)…..5 micrograms Purified pertactin (PRN)…………………………...3 micrograms Inactivated type 1 poliovirus (Mahoney)……….40 D antigen units** Inactivated type 2 poliovirus (MEF-1)………….8 D antigen units** Inactivated type 3 poliovirus (Saukett)…………32 D antigen units** Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate)……………………10 micrograms conjugated to tetanus toxoid (PRP-T)…………..20 micrograms * As lower confidence limit (p=0.95) of activity measured according to the assay described in the European Pharmacopoeia **or equivalent antigenic quantity determined by a suitable immunochemical method. Active components of the vaccine are inactivated with either formaldehyde or glutaraldehyde. Inactivated poliovirus components are produced using the Vero cell line.
• Indications
  PEDIACEL® is indicated for the active immunisation of infants against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. PEDIACEL® may also be administered as a single dose to children who have previously completed a primary immunisation series with diphtheria, tetanus, pertussis, polio and Hib antigens (See Adverse Reactions), in accordance with the applicable official recommendations.
• Adult Dosage
  

  Primary Immunisation Series in Infancy

  The primary immunisation series in infancy may be commenced from two months of age according to applicable official recommendations. A single 0.5 millilitre dose should be given on three separate occasions with at least one month between doses.

  There are no data regarding the administration of PEDIACEL for one or two doses and use of different vaccine(s) for other dose(s). Therefore, it is recommended that infants who receive PEDIACEL for the first dose should also receive this vaccine for the second and third doses of the primary immunisation series.

  Booster Dose

  After completion of the primary series, a booster dose of Hib conjugate vaccine should be administered. The timing of this Hib conjugate booster dose should be in accordance with official recommendations.

  A single 0.5 millilitre dose of PEDIACEL may be used to provide the Hib booster dose if it is officially recommended to boost responses to all other antigens in the vaccine at the same time.

  Based on safety and immunogenicity data from clinical studies, PEDIACEL should preferably be given to children who received this same vaccine in infancy. However, if necessary, PEDIACEL may be given at this age to children who received other vaccines in infancy.

  PEDIACEL should not be administered to children after reaching the fourth birthday.

  Method of Administration

  PEDIACEL should be administered intramuscularly. The recommended injection sites are the anterolateral aspect of the thigh in infants and the deltoid region in older children.

• Child Dosage
  Primary Immunisation Series in Infancy The primary immunisation series in infancy may be commenced from two months of age according to applicable official recommendations. A single 0.5 millilitre dose should be given on three separate occasions with at least one month between doses. There are no data regarding the administration of PEDIACEL® for one or two doses and use of different vaccine(s) for other dose(s). Therefore, it is recommended that infants who receive PEDIACEL® for the first dose should also receive this vaccine for the second and third doses of the primary immunisation series. Booster Dose After completion of the primary series, a booster dose of Hib conjugate vaccine should be administered. The timing of this Hib conjugate booster dose should be in accordance with official recommendations. A single 0.5 millilitre dose of PEDIACEL® may be used to provide the Hib booster dose if it is officially recommended to boost responses to all other antigens in the vaccine at the same time. Based on safety and immunogenicity data from clinical studies, PEDIACEL® should preferably be given to children who received this same vaccine in infancy. However, if necessary, PEDIACEL® may be given at this age to children who received other vaccines in infancy. PEDIACEL® should not be administered to children after reaching the fourth birthday. Method of Administration PEDIACEL® should be administered intramuscularly. The recommended injection sites are the anterolateral aspect of the thigh in infants and the deltoid region in older children.
• Contra Indications
  

  PEDIACEL should not be given to children who:

  • Are known to be hypersensitive to any component of the vaccine (including neomycin, streptomycin and polymyxin B which may be present in trace amounts).

  • Have had a previous severe local or general reaction to this vaccine or to any other vaccine that contains one or more of the antigenic components.

  • Have experienced encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.

  • Have a progressive neurologic disorder, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with these common conditions until the treatment regimen has been established, the condition has stabilized, and the benefit clearly outweighs the risk.

  • Have a fever or acute severe systemic illness. In this case vaccination should be postponed until the child has recovered. Minor infections without fever or systemic upset are not reasons to postpone vaccination.

• Special Precautions
  

  As with all vaccines, appropriate facilities and medication such as epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis or hypersensitivity following injection.

  If any of the following events are known to have occurred in temporal relation to a previous dose of a pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:

  • Temperature of 40°C within 48 hours, not due to another identifiable cause.

  • Hypotonic hyporesponsive episode (HHE): a syndrome characterised by acute diminution of sensory awareness or loss of consciousness, accompanied by pallor and muscle hypotonicity. The onset is usually 1-12 hours after vaccination and the episode may last from a few minutes up to 36 hours. Recovery is complete with no persistent sequelae.

  • Persistent, inconsolable crying lasting more than 3 hours occurring within 48 hours of vaccination.

  • Convulsions with or without fever occurring within 3 days of vaccination.

  In children with a progressive, evolving or unstable neurological condition (including seizures), immunisation should be deferred until the condition is corrected or stable.

  The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency. It is recommended to postpone vaccination until the end of such treatment or the resolution of disease. Nevertheless, vaccination of subjects with chronic immunodeficiency (such as those with HIV infection or on long-term immunosuppressive therapy) is recommended even though the immunological response may be impaired and the degree of protection may be limited.

  Intramuscular injections should be given with care in patients with thrombocytopenia or bleeding disorders due to the risk of haemorrhage.

  The vaccine should be given intramuscularly since subcutaneous administration increases the chances of an injection site reaction. Do not administer by intradermal or intravenous injection.

  If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary immunization schedule has been completed.

  PEDIACEL does not protect against infectious diseases caused by Haemophilus influenzae other than type b, or against meningitis caused by other organisms.

  As with any vaccine, immunisation with PEDIACEL may not protect all recipients from the infections that it is intended to prevent.

  Applicable official recommendations for childhood immunisations should be consulted before administering this vaccine to children in or after the second year of life since this exact combination of antigens may not be considered appropriate and/or necessary after completion of the infant immunisation series.

  The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization 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.

• Interactions
  

  PEDIACEL may be administered at the same time as, but as a separate injection to, meningococcal group C conjugate vaccines or hepatitis B vaccines. Injections should be made into separate sites and, preferably, into separate limbs.

  Antibody responses to the Hib component of PEDIACEL (PRP conjugated to tetanus toxoid; see section 2) were lower when a meningococcal group C CRM₁₉₇ conjugate vaccine was co-administered as a separate injection than when a meningococcal group C tetanus toxoid conjugate vaccine was co-administered as a separate injection at 2, 3 and 4 months of age. The clinical significance of these observations is unknown but the findings relating to meningococcal group C CRM₁₉₇ conjugate vaccine may have implications for the timing of and need for a Hib conjugate booster dose.

  The type of meningococcal conjugate vaccine that is co-administered may also affect responses to the diphtheria and tetanus components of PEDIACEL. Anti-diphtheria responses were higher when a meningococcal group C CRM₁₉₇ conjugate was co-administered with PEDIACEL and anti-tetanus responses were higher when a meningococcal group C tetanus toxoid conjugate was co-administered. However, responses to both these antigens were satisfactory regardless of the type of meningococcal group C conjugate that was given.

  PEDIACEL did not affect the proportions of infants with meningococcal group C serum bactericidal antibody (SBA) titres of at least 1:8 (measured with rabbit complement) when co-administered with either a CRM₁₉₇ conjugate or a tetanus toxoid conjugate vaccine. However, the SBA geometric mean titres (GMTs) were numerically lower after co-administration with PEDIACEL than were seen when these same meningococcal group C conjugate vaccines were co-administered with a whole cell pertussis (as DTwP) vaccine. Also, the SBA GMT when PEDIACEL was co-administered with a meningococcal group C tetanus toxoid conjugate vaccine was significantly lower than that seen after co-administration with a CRM₁₉₇ conjugate. However, the clinical significance of the lower SBA GMTs is unknown.

  There are currently no data on the concomitant use of PEDIACEL and pneumococcal conjugate vaccine. However, concomitant use may be considered if medically important or in accordance with applicable official recommendations.

  There are no data on immune responses to hepatitis B vaccines when co-administered with PEDIACEL. However, there are no safety concerns regarding co-administration.

  Except for immunosuppressive therapy, no significant interaction with other treatments or biological products is anticipated.

• Adverse Drug Reactions
  

  In controlled clinical studies performed with PEDIACEL, 71% of 451 infants immunised at 2, 4 and 6 months experienced a reaction (pain, erythema or oedema) at the injection site within the first 24 hours after vaccination. In 16% of infants the reaction was of moderate to severe intensity. Also, 64% of infants experienced a systemic reaction, which was of moderate to severe intensity in 16%.

  There was a trend for an increased frequency of injection site reactions when a fourth dose of PEDIACEL was given to 401 children in the second year of life. Pain was reported in 33%, erythema in 23% and oedema in 16% compared to rates of 18%, 11% and 11%, respectively, during the primary series. The frequency of systemic reactions was similar whether PEDIACEL was administered in infancy or in the second year of life.

  The reactions observed were as follows:

  Nervous system disorders
  Rare (0.01-0.1%)	Febrile convulsions. Hypotonic hyporesponsive episodes (HHE).
  Gastrointestinal disorders
  Common (1-10%):	Anorexia, diarrhoea and vomiting.
  General disorders and administration site conditions
  Very common (>10%):	Pain, erythema and oedema at the injection site. Irritability, malaise, increased crying and fever.
  Very rare (<0.01%):	High fever (>40.5°C). Unusual high-pitched or inconsolable crying. Extensive limb swelling.

  Large injection site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints, have been reported following administration of acellular-pertussis contained in PEDIACEL. These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. The risk appeared to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.

  In a controlled clinical study of PEDIACEL, administered concomitantly with meningococcal group C conjugate vaccine, 71% of 121 infants immunised at 2, 3 and 4 months experienced a reaction (pain, erythema or oedema) at the PEDIACEL injection site within the first seven days after vaccination. Also, 92% of infants experienced a systemic reaction within the first seven days after vaccination. The rates of moderate to severe reactions were similar to those described at 2, 4 and 6 months.

  Acute allergic reactions have been reported after diphtheria, tetanus and/or pertussis vaccines. Manifestations include dyspnoea, cyanosis, urticaria, angioneurotic oedema, hypotension and, rarely, anaphylaxis.

  A persistent nodule at the site of vaccination may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue. Rarely aseptic abscesses have been reported.

  Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus Influenza type b containing vaccines. If this reaction occurs, it does so mainly after primary injections and is observed within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events resolve spontaneously without sequelae within 24 hours.

  Data from Post Marketing Surveillance

  Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of PEDIACEL. These events have been very rarely reported (<0.01%); however, the exact incidence rates cannot precisely be calculated.

  Nervous system disorders

  Afebrile convulsions.

  General disorders and administration site conditions

  Pallor

  Somnolence

  Additional Information on Special Populations

  Apnoea in very premature infants (28 weeks of gestation).