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Daptacel

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Daptacel

Daptacel

SIDE EFFECTS

Data from Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

A total of 17,577 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine have been administered to infants and children in 8 clinical studies. In all, 4,998 children received 3 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 1,725 of these children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, and 485 of these children received 5 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection. There were fewer of the solicited common local and systemic reactions following DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine than following the whole-cell pertussis DTP vaccine. As shown in Table 1, the 2,587 infants who received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4 and 6 months of age had similar rates of reactions within 24 hours as recipients of DT and significantly lower rates than infants receiving whole-cell pertussis DTP.

Table 1: Percentage of Infants from Sweden I Efficacy Trial with Local or Systemic Reactions within 24 Hours Post-Dose 1, 2 and 3 of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine compared with DT and Whole-Cell Pertussis DTP Vaccines

EVENT Dose 1
(2 MONTHS)
Dose 2
(4 MONTHS)
Dose 3
(6 MONTHS)
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,587
DT
N =2,574
DTP
N =2,102
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,563
DT
N =2,555
DTP
N =2,040
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,549
DT
N =2,538
DTP
N =2,001
Local
  Tenderness (Any) 8.0* 8.4 59.5 10.1* 10.3 60.2 10.8* 10.0 50.0
  Redness ≥ 2 cm 0.3* 0.3 6.0 1.0* 0.8 5.1 3.7* 2.4 6.4
  Swelling ≥ 2 cm 0.9* 0.7 10.6 1.6* 2.0 10.0 6.3* 3.9 10.5
Systemic
  Fever 7.8* 7.6 72.3 19.1* 18.4 74.3 23.6* 22.1 65.1
   ≥ 38°C (100.4°F) Fretfulness§ 32.3 33.0 82.1 39.6 39.8 85.4 35.9 37.7 73.0
  Anorexia 11.2* 10.3 39.2 9.1* 8.1 25.6 8.4* 7.7 17.5
  Drowsiness 32.7* 32.0 56.9 25.9* 25.6 50.6 18.9* 20.6 37.6
  Crying ≥ 1 hour 1.7* 1.6 11.8 2.5* 2.7 9.3 1.2* 1.0 3.3
  Vomiting 6.9* 6.3 9.5 5.2** 5.8 7.4 4.3 5.2 5.5
DT: Swedish National Biologics Laboratories DTP: Sanofi Pasteur Inc.
N = Number of evaluable subjects
* p < 0.001: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine versus whole-cell pertussis DTP
p < 0.0001: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine versus DT
Rectal temperature
§ Statistical comparisons were not made for this variable
** p < 0.003: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine versus whole-cell pertussis DTP

The incidence of serious and less common selected systemic events in the Sweden I Efficacy Trial is summarized in Table 2.

Table 2: Selected Systemic Events: Rates Per 1,000 Doses after Vaccination at 2, 4 and 6 Months of Age in Sweden I Efficacy Trial

EVENT Dose 1
(2 MONTHS)
Dose 2
(4 MONTHS)
Dose 3
(6 MONTHS)
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,587
DT
N =2,574
DTP
N =2,102
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,565
DT
N =2,556
DTP
N =2,040
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,551
DT
N =2,539
DTP
N =2,002
Rectal temperature ≥ 40°C (104°F) within 48 hours of vaccination 0.39 0.78 3.33 0 0.78 3.43 0.39 1.18 6.99
Hypotonic-hypo-responsive episode within 24 hours of vaccination 0 0 1.9 0 0 0.49 0.39 0 0
Persistent crying ≥ 3 hours within 24 hours of vaccination 1.16 0 8.09 0.39 0.39 1.96 0 0 1.0
Seizures within 72 hours of vaccination 0 0.39 0 0 0.39 0.49 0 0.39 0
N = Number of evaluable subjects

In the Sweden I Efficacy Trial, one case of whole limb swelling and generalized symptoms, with resolution within 24 hours, was observed following dose 2 of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. No episodes of anaphylaxis or encephalopathy were observed. No seizures were reported within 3 days of vaccination with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. Over the entire study period, 6 seizures were reported in the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine group, 9 in the DT group and 3 in the whole-cell pertussis DTP group, for overall rates of 2.3, 3.5 and 1.4 per 1,000 vaccinees, respectively. One case of infantile spasms was reported in the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine group. There were no instances of invasive bacterial infection or death.

In a US study, children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4, 6, and 15-17 months of age. A total of 1,454 children received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine and were included in the safety analyses. Of these, 51.7% were female, 77.2% Caucasian, 6.3% Black, 6.5% Hispanic, 0.9% Asian and 9.1% other races. In a subsequent study, a non-random subset of 485 of these children received a fifth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 4-6 years of age. The children included in the fifth dose study were representative of all children who received four doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the earlier study with regard to frequencies of solicited local and systemic adverse events following the fourth dose. At 2, 4, and 6 months of age, DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate) (sanofi pasteur, SA), inactivated poliovirus vaccine (IPV) (sanofi pasteur, SA), and 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.). Infants had received the first dose of hepatitis B vaccine at 0 months of age. At 2 and 6 months of age, hepatitis B vaccine (recombinant) (Merck & Co., Inc.) was also administered concomitantly with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. Based on random assignment, the fourth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered either alone; concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine; or concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine, 7-valent pneumococcal conjugate vaccine, measles, mumps, rubella (MMR) vaccine (Merck & Co., Inc.), and varicella vaccine (Merck & Co., Inc.). The fifth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with IPV and MMR vaccine.

In the US studies, the occurrence of solicited local and systemic adverse events listed in Table 3 was recorded daily by parents or guardians for Days 0-7 following vaccination. For Days 0 and 1 following the first three doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, signs and symptoms of HHE also were solicited. Periodic telephone calls were made to inquire about adverse events. Serious adverse events were monitored during the two studies, through 6 months following the fourth and fifth doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, respectively.

The incidence and severity of selected solicited local and systemic adverse events that occurred within 3 days following each dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine are shown in Table 3. The incidence of redness, tenderness and swelling at the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) injection site increased with the fourth and fifth doses, with the highest rates reported after the fifth dose.

Table 3: Number (Percentage) of Children from US Studies with Selected Solicited Local and Systemic Adverse Events by Severity Occurring Between 0 to 3 Days after Each Dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Vaccine

  Dose 1* Dose 2* Dose 3* Dose 4* Dose 5*
N = 1390-1406
%
N = 1346-1360
%
N = 1301-1312
%
N = 1118-1144
%
N = 473-481
%
Injection Site Reactions (DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine injection site)
Redness
   > 5 mm 6.2 7.1 9.6 17.3 35.8
  25 - 50 mm 0.6 0.5 1.9 6.3 10.4
   > 50 mm 0.4 0.1 0.0 3.1 15.8
Swelling
   > 5 mm 4.0 4.0 6.5 11.7 23.9
  25 - 50 mm 1.2 0.6 1.0 3.2 5.8
   > 50 mm 0.4 0.1 0.1 1.6 7.7
Tenderness
  Any 48.8 38.2 40.9 49.5 61.5
  Moderate 16.5 9.9 10.6 12.3 11.2
  Severe 4.1 2.3 1.7 2.2 1.7
Increase in Arm Circumference
   > 5 mm       30.1 38.3
  20 - 40 mm - - - 7.0 14.0
   > 40 mm       0.4 1.5
Interference with Normal Activity of the Arm§
  Any - - - - 20.4
  Moderate         5.6
  Severe         0.4
Systemic Reactions
Fever**
   ≥ 38.0°C 9.3 16.1 15.8 10.5 6.1
   > 38.5-39.5°C 1.5 3.9 4.8 2.7 2.1
   > 39.5°C 0.1 0.4 0.3 0.7 0.2
Decreased Activity/Lethargy††
  Any 51.1 37.4 33.2 25.3 21.0
  Moderate 23.0 14.4 12.1 8.2 5.8
  Severe 1.2 1.4 0.6 1.0 0.8
Inconsolable Crying‡‡
  Any 58.5 51.4 47.9 37.1 14.1
  Moderate 14.2 12.6 10.8 7.7 3.5
  Severe 2.2 3.4 1.4 1.5 0.4
Fussiness/Irritability§§
  Any 75.8 70.7 67.1 54.4 34.9
  Moderate 27.7 25.0 22.0 16.3 7.5
  Severe 5.6 5.5 4.3 3.9 0.4
* In one U.S. study, children received four doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. A non-random subset of these children received a fifth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in a subsequent study.
Doses 1-4 - Moderate: subject cries when site is touched; Severe: subject cries when leg or arm is moved. Dose 5 - Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
The circumference of the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine-injected arm at the level of the axilla was monitored following the fourth and fifth doses only. Increase in arm circumference was calculated by subtracting the baseline circumference pre-vaccination (Day 0) from the circumference post-vaccination
§ Moderate: decreased use of arm, but did not require medical care or absenteeism; Severe: incapacitating, refusal to move arm, may have/or required medical care or absenteeism.
** For Doses 1-3, 53.7% of temperatures were measured rectally, 45.1% were measured axillary, 1.0% were measured orally, and 0.1% were measured by an unspecified route. For Dose 4, 35.7% of temperatures were measured rectally, 62.3% were measured axillary, 1.5% were measured orally, and 0.5% were measured by an unspecified route. For Dose 5, 0.2% of temperatures were measured rectally, 11.3% were measured axillary, 88.4% were measured orally. Fever is based upon actual temperatures recorded with no adjustments to the measurement for route.
†† Dose 1-4 - Moderate: interferes with and limits daily activity, less interactive; Severe: disabling (not interested in usual daily activity, subject cannot be coaxed to interact with caregiver). Dose 5 - Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
‡‡ Doses 1-4 - Moderate: 1 to 3 hours inconsolable crying; Severe: > 3 hours inconsolable crying. Dose 5 - Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
§§ Doses 1-4: Moderate: Irritability for 1 to 3 hours; Severe: irritability for > 3 hours. Dose 5: Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.

In the US study in which children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, of 1,454 subjects who received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 5 (0.3%) subjects experienced a seizure within 60 days following any dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. One seizure occurred within 7 days post-vaccination: an infant who experienced an afebrile seizure with apnea on the day of the first vaccination. Three other cases of seizures occurred between 8 and 30 days post-vaccination. Of the seizures that occurred within 60 days post-vaccination, 3 were associated with fever. In this study, there were no reported cases of HHE following DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. There was one death due to aspiration 222 days post-vaccination in a subject with ependymoma. Within 30 days following any dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 57 (3.9%) subjects reported at least one serious adverse event. During this period, the most frequently reported serious adverse event was bronchiolitis, reported in 28 (1.9%) subjects. Other serious adverse events that occurred within 30 days following DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine include three cases of pneumonia, two cases of meningitis and one case each of sepsis, pertussis (post-dose 1), irritability and unresponsiveness.

In the 5th dose study of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the US, within 30 days following the 5th dose consecutive dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 1 (0.2%) subject reported 2 serious adverse events (bronchopasm and hypoxia).

In another study (Sweden II Efficacy Trial), 3 DTaP vaccines and a whole-cell pertussis DTP vaccine, none of which are licensed in the US, were evaluated to assess relative safety and efficacy. This study included HCPDT, a vaccine made of the same components as DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine but containing twice the amount of detoxified PT and four times the amount of FHA (20 µg detoxified PT and 20 µg FHA). HHE was observed following 29 (0.047%) of 61,220 doses of HCPDT; 16 (0.026%) of 61,219 doses of an acellular pertussis vaccine made by another manufacturer; and 34 (0.056%) of 60,792 doses of a whole-cell pertussis DTP vaccine. There were 4 additional cases of HHE in other studies using HCPDT vaccine for an overall rate of 33 (0.047%) in 69,525 doses.

Data from Post-Marketing Experience

The following adverse events have been spontaneously reported during the post-marketing use of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the US and other countries. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association to DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

  • Cardiac disorders

Cyanosis

  • Gastro-intestinal disorders

Nausea, diarrhea

  • General disorders and administration site conditions:

Local reactions: injection site pain, injection site rash, injection site nodule, injection site mass, extensive swelling of injected limb (including swelling that involves adjacent joints).

  • Infections and infestations

Injection site cellulitis, cellulitis, injection site abscess

  • Immune system disorders

Hypersensitivity, allergic reaction, anaphylactic reaction (edema, face edema, swelling face, pruritus, rash generalized) and other types of rash (erythematous, macular, maculo-papular)

  • Nervous system disorders

Convulsions: febrile convulsion, grand mal convulsion, partial seizures. HHE, hypotonia, somnolence

  • Psychiatric disorders Screaming

Read the Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Administration with Other Vaccines

In clinical trials, DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with one or more of the following U.S. licensed vaccines: Hib conjugate vaccine, IPV, hepatitis B vaccine, pneumococcal conjugate vaccine, MMR vaccine, and varicella vaccine. [See ADVERSE REACTIONS and Clinical Studies.] When DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is given at the same time as another injectable vaccine(s), the vaccine should be administered with different syringes.

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 (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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