Daptacel

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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

    • Daptacel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids, acellular pertussis vaccine; aluminum phosphate adsorbed; susp for IM inj; contains 2-phenoxyethanol, formaldehyde (trace), glutaraldehyde (trace).

    Pharmacological Class

    DTaP.

    How Supplied

    Single-dose vials (0.5mL)—1, 5, 10

    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.

    Manufacturer

    Sanofi Pasteur, Inc.

    Mechanism of Action

    Protection against tetanus is due to the development of neutralizing antibodies to tetanus toxin. Protection against diphtheria is due to the development of neutralizing antibodies to diphtheria toxin. B pertussis, a Gram-negative coccobacillus that causes pertussis, produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.

    Daptacel Indications

    Indications

    Diphtheria, tetanus, and pertussis immunization in children 6 weeks through 6 years of age (before 7th birthday).

    Daptacel Dosage and Administration

    Adult

    Not recommended.

    Children

    Each dose is 0.5mL IM in anterolateral thigh or deltoid. 5-dose series: Give 1st dose preferably at 2 months of age (may give as early as 6 weeks of age); then give 2nd dose 6–8 weeks later, then give 3rd dose 6–8 weeks later; give 4th dose at 15–20 months of age; give 5th dose at 4–6 years of age. May be used to complete primary series in children who received ≥1 whole-cell DTP doses: see full labeling.

    Children

    Immunization Series

    • Each dose is 0.5mL IM in anterolateral thigh or deltoid. 

    • Administer as a 5-dose series at 2, 4, and 6 months of age (at intervals of 6-8 weeks), at 15-20 months of age and at 4-6 years of age. May give the first dose as early as 6 weeks of age. 

      • Four doses of Daptacel constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of Daptacel constitute a primary immunization course for diphtheria and tetanus. The fourth and fifth doses are boosters for diphtheria and tetanus immunization.

    Mixed Sequences of Daptacel and other DTaP-containing Vaccines 

    • Daptacel contains the same pertussis antigens, manufactured by the same process, as Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) vaccine] and Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine). Pentacel and Vaxelis contain twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as Daptacel.

    • May use Daptacel as any of the doses in a 5-dose DTaP series initiated with Pentacel or Vaxelis.

    Administration

    • Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. Do not administer the product if particulate matter and/or discoloration exist.

    • Just prior to use, shake the vial well until it's a uniform, white, cloudy suspension.

    • For infants younger than 1 year, administer Daptacel into the anterolateral aspect of the thigh as it is the preferred site of injection.

    • For older children, administer Daptacel into the deltoid muscle.

    • Do not inject Daptacel into the gluteal area or areas where there may be a major nerve trunk.

    • Only administer via intramuscular injection. Do not combine Daptacel through reconstitution or mix with any other vaccine.

    Daptacel Contraindications

    Contraindications

    Anaphylaxis associated with any previous dose. Encephalopathy within 7 days after a previous pertussis-containing vaccine. Progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    Daptacel Boxed Warnings

    Not Applicable

    Daptacel Warnings/Precautions

    Warnings/Precautions

    Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), seizures (within 3 days), Guillain-Barre Syndrome (within 6 weeks) of previous tetanus toxoid-containing vaccine. Seizure risk (may give antipyretic). Have epinephrine inj (1:1000) available. Immunocompromised. Latex allergy. Pregnancy (Cat.C).

    Warnings/Precautions

    Management of Acute Allergic Reactions

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

    Adverse Reactions Following Prior Pertussis Vaccination

    • Carefully consider the potential benefits and possible risks of administering Daptacel if any of the following events occur after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component:

      • 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 3 hours within 48 hours. 

      • Seizures with or without fever within 3 days.

    Guillain-Barré Syndrome and Brachial Neuritis

    • The risk of Guillain-Barré Syndrome (GBS) may be increased following Daptacel if GBS occurred within 6 weeks of a previous vaccine containing tetanus toxoid.

    • Evidence has been found for a causal relation between tetanus toxoid and both GBS and brachial neuritis.

    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 an acellular pertussis component (including Daptacel) and for the following 24 hours after; may administer appropriate antipyretic to reduce the possibility of post-vaccination fever. 

    Limitations of Vaccine Effectiveness

    • Daptacel may not protect all individuals.

    Altered Immunocompetence

    • Immunosuppressed persons, including those receiving immunosuppressive therapy may not obtain the expected immune response.

    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.

    Syncope

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

    Pediatric Considerations

    • 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.

    Daptacel Pharmacokinetics

    See Literature

    Daptacel Interactions

    Interactions

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

    Daptacel Adverse Reactions

    Adverse Reactions

    Fussiness/irritability, inconsolable crying, lethargy, fever, inj site reactions.

    Daptacel Clinical Trials

    Clinical Trials

    Diphtheria

    • A US study evaluated children who received 4 doses of Daptacel at 2, 4, 6 and 15 to 17 months of age. 

    • After the third dose, 100% (N=1099) achieved diphtheria antitoxin levels of ≥0.01 IU/mL and 98.5% achieved diphtheria antitoxin levels of ≥0.10 IU/mL.

    • Among a random subset of children who received the fourth dose of Daptacel at 15-16 months of age, 96.5% (N = 659) achieved diphtheria antitoxin levels of ≥1.0 IU/mL after the fourth dose. 

    Tetanus

    • A US study evaluated children who received 4 doses of Daptacel at 2, 4, 6 and 15 to 17 months of age.

    • After the third dose, 100% (N = 1,037) achieved tetanus antitoxin levels of ≥0.10 IU/mL. 

    • Among a random subset of children who received the fourth dose of Daptacel at 15-16 months of age, 98.8% (N = 681) achieved tetanus antitoxin levels of ≥1.0 IU/mL after the fourth dose. 

    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.

    • The study evaluated the efficacy and safety of Daptacel in 9829 infants who received 1 of 4 vaccines at 2, 4, and 6 months of age: Daptacel (N=2587); another investigational acellular pertussis vaccine (N=2566); whole-cell pertussis DTP vaccine (N=2102); or DT vaccine as placebo (Swedish National Bacteriological Laboratory; N =2574). 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.

    US Bridging Study

    • The study compared the antibody responses following 3 doses of Daptacel in US infants at 2, 4, and 6 months of age to those from a subset of the infants enrolled in the Sweden I Efficacy Trial. The study evaluated 2 lots of Daptacel, including the lot used in the Sweden I Efficacy Trial. Assays were performed in parallel on the available sera from the US and Swedish infants.

    • Antibody responses to all the antigens were similar except for those to the PRN component. For both lots of Daptacel, the geometric mean concentration (GMC) and percent response to PRN in US infants (Lot 006, N = 107; Lot 009, N = 108) were significantly lower after 3 doses of vaccine than in Swedish infants (N = 83).

    • In separate US and Canadian studies in which children received Daptacel at 2, 4 and 6 months of age, with a fourth dose at either 17-20 months (Canadian study) or 15-16 months (random subset from US study) of age, antibody responses to each pertussis antigen following the fourth dose (Canadian study N = 275; US study N = 237-347) were at least as high as those seen in the Swedish infants after 3 doses.

    US Study 005

    • The study randomly assigned infants to receive 3 doses of Vaxelis at 2, 4, and 6 months of age and Daptacel and PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] at 15 months of age, or Control group vaccines (3 doses of Pentacel vaccine at 2, 4, and 6 months of age + Recombivax HB [Hepatitis B Vaccine (Recombinant)] at 2 and 6 months of age and Daptacel and ActHIB [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] at 15 months of age). 

    • All patients received concomitant Prevnar 13 at 2, 4, 6, and 15 months of age. To complete the 4-dose pertussis primary vaccination series, participants in both groups received Daptacel at 15 months of age and were evaluated for immune responses to pertussis antigens one month later.

    • The non-inferiority criteria for vaccine response rates and GMCs for all pertussis antigens were met following the fourth dose.

     

    Concomitantly Administered Vaccines

    US Bridging Study

    • The study evaluated infants who received Daptacel concomitantly with Hib conjugate vaccine (Sanofi Pasteur SA) according to local practices. Anti-PRP immune response was 261 infants who received 3 doses of Hib conjugate vaccine.

    • One month after the third dose, 96.9% achieved anti-PRP antibody levels of at least 0.15 mcg/mL and 82.7% achieved antibody levels of at least 1.0 mcg/mL. 

    US Study

    • The study evaluated infants who received Daptacel concomitantly with Hib conjugate vaccine, IPV, 7-valent pneumococcal conjugate vaccine, and hepatitis B vaccine at 7 months of age.

    • 100% of patients (N=1050-1097) had protective neutralizing antibody levels (≥1:8 1/dil) for poliovirus types 1, 2 and 3; and 92.4% (N = 998) achieved anti-hepatitis B surface antigen levels ≥10.0 mIU/mL.

    • 91.3%-98.9% (N = 1,027-1,029) achieved anti-pneumococcal polysaccharide levels ≥0.5 mcg/mL for serotypes 4, 9V, 14, 18C, 19F and 23F and 80.7% (N = 1,027) achieved an anti-pneumococcal polysaccharide level ≥0.5 mcg/mL for serotype 6B.

    • The mumps seroresponse rate was lower when Daptacel was administered concomitantly (86.6%; N = 307) vs non-concomitantly (90.1%; N = 312) with the first dose of MMR vaccine [upper limit of 90% confidence interval for difference in rates (non-concomitant minus concomitant) >5%]. There was no evidence for interference in the immune response to the measles, rubella, and varicella antigens or to the fourth dose of the 7-valent pneumococcal conjugate vaccine with concomitant administration of Daptacel. 

    US Randomized, Multicenter Clinical Trial

    • The study evaluated children 4 to 6 years of age who received Daptacel concomitantly with: IPV (Sanofi Pasteur SA) followed 30 days later by Menactra (Group A); Menactra followed 30 days later by IPV (Group B); or 30 days after concomitant administration of Menactra and IPV (Group C). Sera were obtained approximately 30 days after each respective vaccination.

    • Antibody response to PT, FHA and PRN (GMC), tetanus and diphtheria when Daptacel was administered with Group B were noninferior to those observed when Daptacel (and IPV) were administered with Group A.

    • The anti-FIM GMCs were marginally lower when Daptacel and Menactra were administered concomitantly but the clinical significance is unknown.

    • When Daptacel (and IPV) were administered 30 days prior to Menactra [Group A], significantly lower serum-bactericidal assay-human complement (SBA-H) GMTs to all 4 meningococcal serogroups were observed compared to when Menactra (and IPV) were administered 30 days prior to Daptacel [Group C]. 

    • When Daptacel was administered concomitantly with Menactra [Group B], SBA-H GMTs to meningococcal serogroups A, C, and W-135 were non-inferior to those observed when Menactra (and IPV) were administered [Group C]. The non-inferiority criterion was marginally missed for meningococcal serogroup Y.

    Daptacel Note

    Not Applicable

    Daptacel Patient Counseling

    Patient Counseling

    • Inform the parent or guardian of the following: 

      • The potential benefits and risks of immunization with Daptacel. 

      • The common adverse reactions that have occurred following administration of Daptacel or other vaccines containing similar components. 

      • Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.

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