Usual Pediatric Dose for Haemophilus influenzae Prophylaxis

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age

Comments:

• The first dose may be given as early as 6 weeks of age.
• Four doses constitute a primary vaccination course against pertussis.
• Three doses constitute a primary vaccination course against diphtheria, tetanus, Haemophilus b, and poliomyelitis, with the fourth dose considered a booster against these diseases.
• This vaccine may be used to complete the first 4 doses of the 5 dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP] series in infants who have received 1 or more DTaP doses and are also scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• This vaccine may be used in infants/children who have received 1 or more doses of another inactivated polio vaccine (IPV) or a Haemophilus b Conjugate vaccine (individual or combination vaccination) and are scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• When this vaccine is administered at the recommended ages, the Advisory Committee on Immunization Practices (ACIP) recommends an additional IPV booster dose at 4 to 6 years old, resulting in a 5 dose IPV series.

Usual Pediatric Dose for Poliomyelitis Prophylaxis

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age

Comments:

• The first dose may be given as early as 6 weeks of age.
• Four doses constitute a primary vaccination course against pertussis.
• Three doses constitute a primary vaccination course against diphtheria, tetanus, Haemophilus b, and poliomyelitis, with the fourth dose considered a booster against these diseases.
• This vaccine may be used to complete the first 4 doses of the 5 dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP] series in infants who have received 1 or more DTaP doses and are also scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• This vaccine may be used in infants/children who have received 1 or more doses of another inactivated polio vaccine (IPV) or a Haemophilus b Conjugate vaccine (individual or combination vaccination) and are scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• When this vaccine is administered at the recommended ages, the Advisory Committee on Immunization Practices (ACIP) recommends an additional IPV booster dose at 4 to 6 years old, resulting in a 5 dose IPV series.

Usual Pediatric Dose for Diphtheria Prophylaxis

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age

Comments:

• The first dose may be given as early as 6 weeks of age.
• Four doses constitute a primary vaccination course against pertussis.
• Three doses constitute a primary vaccination course against diphtheria, tetanus, Haemophilus b, and poliomyelitis, with the fourth dose considered a booster against these diseases.
• This vaccine may be used to complete the first 4 doses of the 5 dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP] series in infants who have received 1 or more DTaP doses and are also scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• This vaccine may be used in infants/children who have received 1 or more doses of another inactivated polio vaccine (IPV) or a Haemophilus b Conjugate vaccine (individual or combination vaccination) and are scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• When this vaccine is administered at the recommended ages, the Advisory Committee on Immunization Practices (ACIP) recommends an additional IPV booster dose at 4 to 6 years old, resulting in a 5 dose IPV series.

Usual Pediatric Dose for Pertussis Prophylaxis

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age

Comments:

• The first dose may be given as early as 6 weeks of age.
• Four doses constitute a primary vaccination course against pertussis.
• Three doses constitute a primary vaccination course against diphtheria, tetanus, Haemophilus b, and poliomyelitis, with the fourth dose considered a booster against these diseases.
• This vaccine may be used to complete the first 4 doses of the 5 dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP] series in infants who have received 1 or more DTaP doses and are also scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• This vaccine may be used in infants/children who have received 1 or more doses of another inactivated polio vaccine (IPV) or a Haemophilus b Conjugate vaccine (individual or combination vaccination) and are scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• When this vaccine is administered at the recommended ages, the Advisory Committee on Immunization Practices (ACIP) recommends an additional IPV booster dose at 4 to 6 years old, resulting in a 5 dose IPV series.

Usual Pediatric Dose for Tetanus Prophylaxis

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age

Comments:

• The first dose may be given as early as 6 weeks of age.
• Four doses constitute a primary vaccination course against pertussis.
• Three doses constitute a primary vaccination course against diphtheria, tetanus, Haemophilus b, and poliomyelitis, with the fourth dose considered a booster against these diseases.
• This vaccine may be used to complete the first 4 doses of the 5 dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP] series in infants who have received 1 or more DTaP doses and are also scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• This vaccine may be used in infants/children who have received 1 or more doses of another inactivated polio vaccine (IPV) or a Haemophilus b Conjugate vaccine (individual or combination vaccination) and are scheduled to receive the other antigens in this vaccine, but safety and immunogenicity of these mixed sequences have not been established.
• When this vaccine is administered at the recommended ages, the Advisory Committee on Immunization Practices (ACIP) recommends an additional IPV booster dose at 4 to 6 years old, resulting in a 5 dose IPV series.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Severe allergic reaction (e.g. anaphylaxis) after a previous dose of this vaccine or any other containing diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated polio vaccine, Haemophilus b vaccine, or any ingredient in this vaccine
• Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizure) of unknown etiology within 7 days of a pertussis containing.
• Progressive neurologic disorder (including infantile spasms, uncontrolled epilepsy, progressive encephalopathy) after any pertussis-containing vaccine; do not administer until a treatment regimen has been established and the condition has stabilized.

Safety and efficacy have not been established in patients older than 5 years; this drug is not recommended for use in these patients.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This vaccine is supplied in two vials; be sure to administer the contents of both vials as directed in package labeling.
• The anterolateral aspect of the thigh is the preferred injection site in infants under 1 year.
• The deltoid may be used in older children.
• Do not administer in the gluteal area or other areas where there may be a major nerve trunk.
• For intramuscular use only; do not give intravenously or subcutaneously.

Storage requirements: Refrigerate; do not freeze.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility:

• Do not mix in the same syringe as other parenteral products.