SCHEDULE FLEXIBILITY SCHEDULE FIT

   

SCHEDULE FLEXIBILITY

PEDIARIX gives you flexibility to catch up those appropriate patients who fell behind schedule

PEDIARIX is indicated until the 7th birthday. Pentacel and Vaxelis are indicated until the 5th birthday1-3

PEDIARIX Vaccination Schedule chart
Baby sitting down
  • 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 the complete 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 manufacturer1

Watch a video about the schedule flexibility of PEDIARIX

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

PEDIARIX has been the foundation of the GSK DTaP-containing portfolio of pediatric vaccines since 2002.1

HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
PEDIARIX brand logo
INFANRIX brand logo
KINRIX brand logo
HIBERIX brand logo
ENGERIX-B brand logo
  • 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 dose8
  • 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.1 However, data are limited regarding the safety of PEDIARIX in such infants1

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

  • *

    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

  • †

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

CDC prefers that vaccine doses in a DTaP series come from the same manufacturer when possible.9,10

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 birthday.1,4,5

Watch a video about the GSK portfolio of pediatric vaccines

INDICATIONS & IMPORTANT SAFETY INFO FOR PEDIARIX, INFANRIX, AND KINRIX

INDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX

IMPORTANT SAFETY INFORMATION FOR PEDIARIX, INFANRIX, AND KINRIX

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 seventh 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 seventh 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 seventh 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 cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • 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. 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
  • 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 cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • 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
  • lmmunocompromised persons, including individual 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

 

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

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

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

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

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

References

  1. Prescribing Information for PEDIARIX.
  2. Prescribing Information for Pentacel.
  3. Prescribing Information for Vaxelis.
  4. Prescribing Information for INFANRIX.
  5. Prescribing Information for KINRIX.
  6. Prescribing Information for HIBERIX.
  7. Prescribing Information for ENGERIX-B.
  8. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for children 18 years or younger, United States, 2025. Reviewed November 21, 2024. Accessed December 12, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
  9. Centers for Disease Control and Prevention. Timing and spacing of immunobiologics. Updated July 24, 2024. Accessed December 12, 2024. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.html
  10. Liang JL, Tiwari T, Moro P, et al. Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations and Reports. 2018;67(2):1-44. doi:https://doi.org/10.15585/mmwr.rr6702a1