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Protective efficacy of INFANRIX against pertussis following 3 doses1,2,*

A double-blind, randomized, active diphtheria and tetanus toxoids (DT)-controlled trial assessed the absolute protective efficacy of INFANRIX against pertussis when administered at 2, 4, and 6 months of age (n=4481)

In clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10% to 53%, depending on reaction and dose number, and were highest following doses 4 and 5. Fever was common (20% to 30%) following doses 1-3. Other common solicited adverse events were drowsiness, irritability/fussiness, and loss of appetite, reported in approximately 15% to 60% of subjects, depending on event and dose number.

CI=confidence interval; DTaP=diphtheria, tetanus, and acellular pertussis.
*The mean length of follow-up was 17 months, beginning 30 days after the third dose of vaccine.
†Typical pertussis as defined by the World Health Organization (WHO), 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.2
‡Clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing.2

In an extended, unblinded follow-up period among children 3 to 6 years,  the efficacy of INFANRIX against typical pertussis was 86% (95% CI: 79-91). Thus, protection against pertussis in children administered 3 doses of  INFANRIX in infancy was sustained to 6 years of age.1,2

PEDIARIX is approved for use as a 3-dose primary series and by itself does not constitute a complete vaccination course for DTaP.1

Watch a video about the efficacy and safety of PEDIARIX

References: 1. Prescribing Information for PEDIARIX. 2. Prescribing Information for INFANRIX.

Indications for PEDIARIX, INFANRIX, and KINRIX

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3‑dose series in infants born of hepatitis B surface antigen (HBsAg)‑negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to 7th birthday).

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

Indication for HIBERIX

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).

Indication for ENGERIX-B

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

Important Safety Information for PEDIARIX, INFANRIX, and KINRIX

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX 
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
  • Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders
  • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
  • The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥105°F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX or INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination 
  • In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite
  • Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients

Important Safety Information for HIBERIX

  • A severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of HIBERIX is a contraindication to administration of HIBERIX
  • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give HIBERIX should be based on consideration of the potential benefits and possible risks
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
  • Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness
  • Vaccination with HIBERIX may not result in protection in all vaccine recipients

Important Safety Information for ENGERIX-B

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast, is a contraindication to administration of ENGERIX-B
  • The tip caps of the prefilled syringes for ENGERIX-B contain natural rubber latex, which may cause allergic reactions
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Temporarily defer ENGERIX-B vaccination of infants with a birth weight less than 2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely
  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to ENGERIX-B
  • In clinical trials with ENGERIX-B, the most frequently reported adverse reactions were injection-site soreness and fatigue
  • Vaccination with ENGERIX-B may not result in protection in all vaccine recipients

 

Click here for full Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Click here for full Prescribing Information for INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

Click here for full Prescribing Information for KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Click here for full Prescribing Information for HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]

Click here for full Prescribing Information for ENGERIX-B [Hepatitis B Vaccine (Recombinant)]

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PDRWCNT190008 November 2019