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PEDIARIX has been the foundation of
GSK’s DTaP-containing vaccine portfolio since 20021,*

Complete Your Primary DTaP Series With PEDIARIX1
Vaccine Birth 2 Months 4 Months 6 months
Hepatitis B Hepatitis B  
DTaP  
IPV  
  • PEDIARIX as a primary series: 3 doses of 0.5 mL each, by intramuscular injection, at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks)1
  • According to CDC, administration of a total of 4 doses of hepatitis B vaccine is permitted when a combination vaccine containing hepatitis B is administered after the birth dose2
  • A 3-dose series of PEDIARIX may be administered to infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth. However, data are limited regarding the safety of PEDIARIX in such infants 
  • Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer1

CDC prefers that vaccine doses in a DTaP series come from the same manufacturer when possible3

With the GSK DTaP portfolio, patients can start and stay with the same DTaP antigen content as early as 6 weeks of age up until the 7th birthday1,4,5

Maintain the continuity of your schedule with vaccines from the GSK pediatric portfolio

HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age1,4-7,*,
Vaccine/
Age
Birth 2 months 4 months 6 months 15-18 months 4-6 years
HepB            
DTaP      
IPV    
Hib            
HepB, DTaP, IPV, and Hib From Birth
Through 6 Years of Age1,4-7,*,†
Vaccine/
Age
HepB DTaP IPV Hib
Birth        
2 months    
4 months  
6 months  
15-18
months
       
4-6 years      
Desktop
Mobile Image

*Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

GSK’s DTaP-containing vaccines are to be administered according to their approved indications.

PEDIARIX gives you flexibility to catch up those appropriate patients who fell behind schedule; Pentacel and Vaxelis are indicated until the 5th birthday1,8,9

  • The recommended dosing interval for PEDIARIX is 6 to 8 weeks, preferably 8 weeks1
  • Three doses of PEDIARIX constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis and completes the vaccination course for hepatitis B1
  • Data are not available on the safety and effectiveness of using PEDIARIX following 1 or more doses of a DTaP vaccine from a different manufacturer 1

Watch a video about the
schedule flexibility of PEDIARIX

Watch a video about the
GSK portfolio of pediatric vaccines

DTaP=diphtheria, tetanus, and acellular pertussis; IPV=inactivated poliovirus vaccine; HBsAg=hepatitis B surface antigen; CDC=Centers for Disease Control and Prevention; HepB=hepatitis B; Hib=Haemophilus infuenzae type b.

References: 1. Prescribing Information for PEDIARIX. 2. Recommended child and adolescent immunization schedule for children 18 years or younger, United States, 2021. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html. Updated February 12, 2021. Accessed April 9, 2021. 3. Timing and spacing of immunobiologics. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html. Updated November 17, 2020. Accessed April 9, 2021. 4. Prescribing Information for INFANRIX. 5. Prescribing Information for KINRIX. 6. Prescribing Information for HIBERIX. 7. Prescribing Information for ENGERIX-B. 8. Prescribing Information for Pentacel. 9. Prescribing Information for Vaxelis.

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 indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (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

  • Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b-­ or tetanus toxoid-containing vaccine or any component of the vaccine 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 any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movement. 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
  • Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur
  • Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained
  • Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX
  • Immunization with HIBERIX does not substitute for routine tetanus immunization
  • Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, sleepiness, fussiness, and restlessness
  • Vaccination with HIBERIX may not result in protection in all vaccine recipients

Important Safety Information for ENGERIX-B

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PDRWCNT210004 June 2021