Pentacel

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Pentacel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (susp); Hib conjugate (tetanus toxoid conjugate, PRP) (lyophilized pwd); 0.5mL/dose; for IM inj after mixing; contains residual trace amounts of formaldehyde, 2-phenoxyethanol, neomycin, polymyxin B.

    Pharmacological Class

    DTaP + IPV + Hib/PRP-T.

    How Supplied

    Doses—5 (2 vials/dose)

    How Supplied

    • The vial stoppers for the DTaP-IPV and ActHIB vaccine components of Pentacel are not made with natural rubber latex.

    • 5 Dose Package containing 5 vials of DTaP-IPV component to be used to reconstitute 5 single-dose vials of lyophilized ActHIB vaccine component.

    Storage

    • Store at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label. Pentacel should be used immediately after reconstitution.

     

    Manufacturer

    Sanofi Pasteur, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Protection against diphtheria is due to the development of neutralizing antibodies to diphtheria toxin. Protection against tetanus is due to the development of neutralizing antibodies to tetanus toxin. B. pertussis, a 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. The presence of poliovirus type-specific neutralizing antibodies has been correlated with protection against poliomyelitis. H. influenzae type b can cause invasive disease such as meningitis and sepsis. Anti-PRP antibody has been shown to correlate with protection against invasive disease due to H. influenzae type b.

    Pentacel Indications

    Indications

    Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age (prior to 5th birthday).

    Pentacel Dosage and Administration

    Adult

    Not recommended.

    Children

    Each dose is 0.5mL IM, in anterolateral thigh (infants) or deltoid muscle. Give as a 4 dose series at 2 months, 4 months, 6 months, and 15–18 months of age. May give 1st dose as early as 6 weeks of age. Previously vaccinated with ≥1 dose of Daptacel, IPV, or Hib conjugate vaccine: Pentacel may be used to complete vaccination series; see full labeling. May give other vaccines concurrently (use separate inj site).

    Children

    Immunization Series

    • Each dose is 0.5mL IM, in anterolateral thigh (infants) or deltoid muscle. Give as a 4 dose series at 2 months, 4 months, 6 months, and 15–18 months of age. May give 1st dose as early as 6 weeks of age. 

    • 4 doses of Pentacel constitute a primary immunization course against pertussis.

    • 3 doses of Pentacel constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the 4th dose is a booster for diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis immunization.

    Mixed Sequences of Pentacel and other DTaP-containing Vaccines

    • Pentacel, Daptacel, Quadracel, and Vaxelis contain the same pertussis antigens. The amount of each of the pertussis antigens is the same in Pentacel, Quadracel, and Vaxelis. Pentacel contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as Daptacel.

    • May use Pentacel as the 4th dose in the 5-dose DTaP series in children who received a 3-dose series of Vaxelis.

    • May use Pentacel to complete the first 4 doses of the 4-dose DTaP series in infants and children who received 1 or more doses of Daptacel and are also scheduled to receive other antigens of Pentacel.

    • After completing a 4-dose series with Pentacel, administer a 5th dose of DTaP vaccine using Daptacel or Quadracel at 4–6 years of age.

    Mixed Sequences of Pentacel and IPV Vaccine

    • May use Pentacel in infants who received 1 or more doses of another licensed IPV vaccine and are scheduled to receive the antigens of Pentacel.

    • After completing a 4-dose series with Pentacel, administer an additional booster dose of IPV vaccine at age 4–6 years, resulting in a t-dose IPV series.

    Mixed Sequences of Pentacel and Haemophilus b Conjugate Vaccine

    • May use Pentacel to complete the vaccination series in infants and children previously vaccinated with one or more doses of Haemophilus b Conjugate Vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel.

    Pentacel Contraindications

    Contraindications

    Anaphylaxis associated with any previous dose or component. Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorder (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    Contraindications

    Hypersensitivity

    • Severe allergic reaction (eg, anaphylaxis) associated with previous diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, inactivated poliovirus vaccine or H. influenzae type b vaccine, or any ingredient of this vaccine.

    Encephalopathy

    • Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.

    Progressive Neurologic Disorder

    • Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    • Do not administer Pentacel to individuals with these conditions until the treatment regimen has been established and the condition has stabilized.

    Pentacel Boxed Warnings

    Not Applicable

    Pentacel Warnings/Precautions

    Warnings/Precautions

    Fever (≥105°F within 48hrs), persistent inconsolable crying (lasting ≥3hrs within 48hrs), shock (within 48hrs), seizure (within 3 days), or Guillain-Barre syndrome (within 6 weeks) of previous tetanus toxoid vaccine. Seizure risk (may pretreat with antipyretics, eg, acetaminophen). May defer in acute febrile illness. Have epinephrine inj (1:1000) available. Immune deficiency. Pregnancy (Cat.C): not recommended.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have epinephrine (1:1000) and other appropriate agents immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.

    • Review the patient’s immunization history for hypersensitivity prior to administration.

    Adverse Reactions following Prior Pertussis Vaccination

    • Carefully consider the potential benefits and possible risks of administering Pentacel if any of the following events occur after administration of a pertussis-containing vaccine:

      • 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 at least 3 hours within 48 hours. 

      • Seizures with or without fever within 3 days.

    Guillain-Barré Syndrome and Brachial Neuritis 

    • Increased risk for Guillain-Barré Syndrome (GBS) after administering Pentacel if GBS occurred within 6 weeks of a previous vaccine containing tetanus toxoid. 

    Infants and Children with a History of Previous Seizures

    • Increased risk of seizure in infants or children with a history of previous seizures at the time of vaccination with a vaccine containing acellular pertussis antigens (including Pentacel) and for the following 24 hours after; may administer appropriate antipyretic to reduce the possibility of post-vaccination fever. 

    Limitations of Vaccine Effectiveness

    • May not protect all individuals.

    Altered Immunocompetence

    • May get suboptimal immune response when Pentacel is administered to immunocompromised persons, including persons receiving immunosuppressive therapy.

    Apnea in Premature Infants

    • Risk of apnea has been observed in some infants born prematurely.

    • Consider the individual infant’s medical status and the potential benefits and risks of vaccination when deciding to administer Pentacel to infants born prematurely.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting.

    Pediatric Considerations

    • Safety and efficacy of Pentacel has not been established in infants less than 6 weeks of age and in children 5 to 16 years of age.

    Pentacel Pharmacokinetics

    See Literature

    Pentacel Interactions

    Interactions

    Concomitant vaccines: see full labeling. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Interactions

    Concomitant Vaccine Administration

    • In clinical trials, the immune responses were evaluated for the concomitant administration of Pentacel with : hepatitis B vaccine, 7-valent pneumococcal conjugate vaccine, MMR and varicella vaccines.

    • Use separate syringes and at different injection sites when administering Pentacel with other injectable vaccines.

    Immunosuppressive Therapies

    • Immunosuppressants, including  irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses): may reduce the immune response to Pentacel.

    Drug/Laboratory Test Interactions 

    • Antigenuria has been detected in some instances following receipt of ActHIB. Urine antigen detection may not have definite diagnostic value in suspected H. influenzae type b disease within 1 week following receipt of Pentacel.

    Pentacel Adverse Reactions

    Adverse Reactions

    Local reactions: inj site erythema, swelling, tenderness. Systemic reactions: fever, crying, fussiness.

    Pentacel Clinical Trials

    Clinical Trials

    Immune responses to Pentacel were evaluated in four US studies: Studies 494-01, P3T06, 494-03, and M5A10. In Study M5A10, participants were randomly assigned to receive Pentacel or separately administered Daptacel, IPOL, and ActHIB at 2, 4, and 6 months of age. Pentacel or Control vaccines were concomitantly administered with 7-valent pneumococcal conjugate (PCV7, Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age, and Hepatitis B vaccine (Merck and Co. or GlaxoSmithKline Biologicals) at 2 and 6 months of age. 

     

    Diphtheria and Tetanus

    • The proportions of participants achieving diphtheria antitoxin and tetanus antitoxoid seroprotective levels 1 month following three and four doses of Pentacel or Daptacel (+ IPOL + ActHIB) in Study P3T06 were as followed, respectively:

      • Post-Dose 3

        • Diphtheria Antitoxin (% ≥0.01 IU/mL): 100% for Pentacel vs 100% for Daptacel

        • Tetanus Antitoxoid (% ≥0.10 IU/mL): 99.7% for Pentacel vs 100% for Daptacel

      • Post-Dose 4

        • Diphtheria Antitoxin (% ≥0.10 IU/mL): 100% for Pentacel vs 100% for Daptacel

        • Tetanus Antitoxoid (% ≥0.10 IU/mL): 100% for Pentacel vs 100% for Daptacel

    Pertussis

    • Sweden I Efficacy Trial

      • A randomized, double-blinded, placebo-controlled study was conducted in Sweden during 1992-1995 (Sweden I Efficacy Trial) under the sponsorship of the National Institute of Allergy and Infectious Diseases.

      • 2587 infants received Daptacel and 2574 infants received a non-US licensed DT vaccine as placebo at 2, 4, and 6 months of age. The mean length of follow-up was 2 years after the third dose of vaccine.

      • The protective efficacy of Daptacel was 84.9% (95% CI, 80.1-88.6) against pertussis after 3 doses using the WHO case definition (≥21 consecutive days of paroxysmal cough with culture or serologic confirmation or epidemiologic link to a confirmed case).

      • The protective efficacy of Daptacel was 77.9% (95% CI, 72.6-82.2) against mild pertussis (≥1 day of cough with laboratory confirmation).

      • Daptacel demonstrated to sustain protection against pertussis for the 2-year follow-up period.

    • Serology Bridging Analysis

      • Immune responses to FHA, PRN, and FIM in a subset of infants who received 3 doses of Daptacel in the Sweden I Efficacy Trial were compared to the Post-Dose 3 and Post-Dose 4 responses in a subset of US children from Study 494-01 who received Pentacel.

      • The noninferiority criteria were met for seroconversion rates for anti-FHA and anti-FIM after Dose 4 of Pentacel compared to Dose 3 of Daptacel. The noninferiority criteria was not met for seroconversion for anti-PRN.

      • The noninferiority criteria were met for GMCs for anti-FHA, anti-PRN, and anti-FIM after Dose 4 of Pentacel compared to Dose 3 of Daptacel. 

    • Study P3T06

      • US infants were randomly asigned to receive either Pentacel or Daptacel + IPOL + ActHIB at 2, 4, 6, and 15–16 months of age.

      • The noninferiority criteria were met for seroconversion rates and GMCs for each of the pertussis antigens after Dose 3 of Pentacel compared with Dose 3 of Daptacel. 

      • The noninferiority criteria were met for all comparisons after Dose 4 of Pentacel compared with Dose 4 of Daptacel, except for anti-PRN GMCs.

    • Study 006

      • US infants were randomly assigned to receive 3 doses of Vaxelis at 2, 4, and 6 months of age and Pentacel at 15 months of age, or control group vaccines (4 doses of Pentacel + Recombivax HB). All patients received concomitant Prevnar 13 at 2, 4, 6, and 15 months of age.

      • The noninferiority criteria for antibody vaccine response rates and GMCs for all pertussis antigens were met after the 4th dose except for GMCs for PRN.

    Poliomyelitis

    • Study P3T06

      • Infants were randomly assigned to receive the first 3 doses of Pentacel or Daptacel + IPOL + ActHIB at 2, 4, and 6 months of age, one month after the third dose of study vaccines.

      • More than 99.4% of patients in both groups achieved neutralizing antibody levels of ≥1:8 for Poliovirus types 1, 2, and 3.

    • Study 494-01

      • Infants were randomly assigned to receive Pentacel or HCPDT + POLIOVAX + ActHIB.

      • GMTs of antibodies to Poliovirus types 1, 2, and 3 one month after Dose 4 of Pentacel were 2304, 4178, and 4415, respectively, and one month following Dose 4 of POLIOVAX were 2330, 2840, and 3300, respectively.

    Invasive Disease due to H. Influenzae Type b

    • Study 494-01

      • Pentacel did not meet the noninferiority criteria for the proportion of patients who achieved an anti-PRP level ≥1.0 mcg/mL and for anti-PRP GMCs compared with separately administered ActHIB.

    • Studies P3T06 and M5A10

      • Pentacel met the noninferiority criteria for the proportion of patient who achieved an anti-PRP level ≥1.0 mcg/mL compared with separately administered ActHIB.

    • Study M5A10

      • Pentacel met the noninferiority criteria for anti-PRP GMCs compared with separately administered ActHIB.

    • Study 494-01

      • At 15 months of age before receiving Dose 4 of study vaccines, 68.6% of Pentacel recipients (N = 829) and 80.8% of separately administered ActHIB recipients (N = 276) had an anti-PRP level ≥0.15 mcg/mL.

      • After Dose 4, 98.2% of Pentacel recipients (N = 874) and 99.0% of separately administered ActHIB recipients (N = 291) had an anti-PRP level ≥1.0 mcg/mL. 

    • Study P3T06

      • At 15 months of age before receiving Dose 4 of study vaccines, 65.4% of Pentacel recipients (N = 335) and 60.7% of separately administered ActHIB recipients (N = 323) had an anti-PRP level ≥0.15 mcg/mL. 

      • Following Dose 4 of study vaccines, 97.8% of Pentacel recipients (N = 361) and 95.9% of separately administered ActHIB recipients (N = 340) had an anti-PRP level ≥1.0 mcg/mL.

    Pentacel Note

    Notes

    Report adverse events to VAERS at (800) 822-7967 and to Sanofi Pasteur at (800) 822-2463.

    Pentacel Patient Counseling

    Patient Counseling

    • Inform patient or guardian of the benefits and risks of the vaccine and the importance of completing the immunization series unless a contraindication to further immunization exists.

    • Inform patient or guardian about potential for adverse reactions. 

    • Provide the Vaccine Information Statements (VIS) with each immunization. 

    • Instruct parent or guardian to report adverse reactions to their health care provider.

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