Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.

Pharmaceutical Name

Trade (marketing or proprietary) name: Infanrix, Daptacel

Generic (nonproprietary or active ingredient) name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Suspension for Intramuscular Injection

Indication and Usage

Reason the product has been approved for sale on the market.

For active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday).

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile vaccine for intramuscular administration. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein). Each 0.5-mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80).

DAPTACEL is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular injection. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), and 5 mcg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative).

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Infanrix

Hypersensitivity: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of INFANRIX is a contraindication. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered.

Encephalopathy: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX.

Progressive Neurologic Disorder: Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

Daptacel

Hypersensitivity: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of DAPTACEL or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of DAPTACEL. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Encephalopathy: 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 is a contraindication to administration of any pertussis-containing vaccine, including DAPTACEL.

Progressive Neurologic Disorder: Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including DAPTACEL. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Infanrix

Guillain-Barré Syndrome: If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including INFANRIX, should be based on careful consideration of the potential benefits and possible risks. When a decision is made to withhold tetanus toxoid, other available vaccines should be given, as indicated.

Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including INFANRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Adverse Reactions following Prior Pertussis Vaccination: If any of the following reactions occur in temporal relation to receipt of a pertussis-containing vaccine, the decision to give any pertussis-containing vaccine, including INFANRIX, should be based on careful consideration of the potential benefits and possible risks:

• Temperature of 40.5oC (105oF) within 48 hours not due to another identifiable cause;
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
• Persistent, inconsolable crying lasting greater than or equal to 3 hours, occurring within 48 hours;
• Seizures with or without fever occurring within 3 days.

Children at Risk for Seizures: For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a pertussis-containing vaccine, including INFANRIX, and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

Apnea in Premature Infants: Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including INFANRIX, 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.

Preventing and Managing Allergic Vaccine Reactions: 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.

Immunosuppressive Therapies: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to INFANRIX.

Daptacel

Management of Acute Allergic Reactions: Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Adverse Reactions Following Prior Pertussis Vaccination: If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer DAPTACEL should be based on careful consideration of potential benefits and possible risks.

• Temperature of 40.5°C (105°F) within 48 hours, not attributable to another identifiable cause.
• Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
• Persistent, inconsolable crying lasting greater than or equal to 3 hours within 48 hours.
• Seizures with or without fever within 3 days.

Guillain-Barré Syndrome and Brachial Neuritis: A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following DAPTACEL.

Infants and Children with a History of Previous Seizures: For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including DAPTACEL) and for the following 24 hours, to reduce the possibility of post-vaccination fever.

Limitations of Vaccine Effectiveness: Vaccination with DAPTACEL may not protect all individuals.

Altered Immunocompetence: If DAPTACEL is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Apnea in Premature Infants: Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including DAPTACEL, to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

Syncope: Syncope (fainting) has been reported following vaccination with DAPTACEL. Procedures should be in place to avoid injury from fainting.

Immunosuppressive Treatments: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to DAPTACEL.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Infanrix can cause Encephalopathy, Syncope (fainting), Cellulitis, Bronchitis, Lymphadenopathy, Thrombocytopenia, Sudden Infant Death Syndrome (SIDS), Anaphylactic reaction, Hypersensitivity, Hypotonia (floppy infant syndrome), Respiratory tract infection, Ear pain, Cyanosis (blue skin), Apnea, Angioedema (swelling), Erythema, Pruritus (chronic itching), Urticaria (hives).

Daptacel can cause Lymphadenopathy, Cyanosis (blue skin), Nausea, Diarrhea, Cellulitis, Injection site abscess, Hypersensitivity, Screaming, Syncope (fainting), Somnolence (sleepiness), Hypotonia (floppy infant syndrome), HHE, Anaphylactic reaction: edema, face edema, swelling face, pruritus (chronic itching), rash generalized, Erythematous, macular, maculo-papular, Convulsions: febrile convulsion, grand mal convulsion, partial seizures.

Limitations of Vaccine Effectiveness

Vaccination with DAPTACEL may not protect all individuals.

Specific Populations

Fertility

INFANRIX/DAPTACEL has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

Pediatric

Safety and effectiveness of INFANRIX in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. INFANRIX is not approved for use in these age groups.

DAPTACEL is not indicated for use in infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of DAPTACEL in these age groups have not been established.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

Diphtheria
Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of
C. diphtheriae. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection; a level of 0.1 IU/mL is regarded as protective.

Tetanus
Tetanus is an acute toxin-mediated infectious disease caused by a potent exotoxin released by C. tetani. Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level. A level of 0.1 IU/mL is considered protective.

Pertussis
Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no well-established serological correlate of protection for pertussis.

Pertussis (whooping cough) is a respiratory disease caused by B pertussis. This Gram-negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.

Analytical Deep Dive

What is informed consent?

Alternatives

Looking for DTAP vaccine alternatives? Here are some products to research:

Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.

The alternative to the DTAP vaccine is to not accept it and treat the viruses naturally when needed. Here are some things to research if you suspect you or your child has each virus.

Tetanus FAQ

Do you worry about tetanus and have been recommended the Tetanus vaccine? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.

Diphtheria FAQ

Do you worry about diphtheria and have been recommended the Tetanus, TDAP, or DTAP vaccines? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.

Pertussis FAQ

Do you worry about pertussis and have been recommended the TDAP or DTAP vaccines? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.