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Daptacel

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Daptacel

Side Effects
Interactions

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.

Approximately 18,000 doses of DAPTACEL vaccine have been administered to infants and children in 9 clinical studies. Of these, 3 doses of DAPTACEL vaccine were administered to 4,998 children, 4 doses of DAPTACEL vaccine were administered to 1,725 children, and 5 doses of DAPTACEL vaccine were administered to 485 children. A total of 989 children received 1 dose of DAPTACEL vaccine following 4 prior doses of Pentacel 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 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 vaccine than following the whole-cell pertussis DTP vaccine. As shown in Table 1, the 2,587 infants who received DAPTACEL 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 vaccine compared with DT and Whole-Cell Pertussis DTP Vaccines

EVENT Dose 1 (2 MONTHS) Dose 2 (4 MONTHS) Dose 3 (6 MONTHS)
DAPTACEL vaccine
N = 2,587
DT
N = 2,574
DTP
N = 2,102
DAPTACEL vaccine
N = 2,563
DT
N = 2,555
DTP
N = 2,040
DAPTACEL 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‡ ≥ 38°C (100.4°F) 7.8* 7.6 72.3 19.1* 18.4 74.3 23.6* 22.1 65.1
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: whole-cell pertussis DTP, Sanofi Pasteur Inc.
N = Number of evaluable subjects
* p < 0.001: DAPTACEL vaccine versus whole-cell pertussis DTP
† p < 0.0001: DAPTACEL vaccine versus DT
‡ Rectal temperature
§ Statistical comparisons were not made for this variable
** p < 0.003: DAPTACEL 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 vaccine
N = 2,587
DT
N = 2,574
DTP
N = 2,102
DAPTACEL vaccine
N = 2,565
DT
N = 2,556
DTP
N = 2,040
DAPTACEL 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
DT: Swedish National B iologics Laboratories
DTP: whole-cell pertussis DTP, Sanofi Pasteur Inc.
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 vaccine. No episodes of anaphylaxis or encephalopathy were observed. No seizures were reported within 3 days of vaccination with DAPTACEL vaccine. Over the entire study period, 6 seizures were reported in the DAPTACEL 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 vaccine group. There were no instances of invasive bacterial infection or death.

In a US study, children received 4 doses of DAPTACEL vaccine at 2, 4, 6 and 15-17 months of age. A total of 1,454 children received DAPTACEL 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. The use of DAPTACEL vaccine as a fifth dose of DTaP vaccine was evaluated in 2 subsequent US clinical studies. In one study, a total of 485 children received DAPTACEL vaccine at 4-6 years of age following 4 prior doses of DAPTACEL vaccine in infancy (DAPTACEL-primed). In a separate study, a total of 989 children received DAPTACEL vaccine at 4-6 years of age following 4 prior doses of Pentacel vaccine in infancy (Pentacel-primed). The children included in these fifth dose studies were non-random subsets of participants from previous DAPTACEL or Pentacel studies. The subsets were representative of all children who received 4 doses of DAPTACEL or Pentacel vaccine in the earlier studies with regard to frequencies of solicited local and systemic adverse events following the fourth dose.

In the US 4-dose DAPTACEL study, at 2, 4, and 6 months of age, DAPTACEL 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 vaccine. Based on random assignment, the fourth dose of DAPTACEL 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.). In the fifth dose studies, DAPTACEL vaccine was administered concomitantly with IPV (all DAPTACEL-primed subjects and 47% of Pentacel-primed subjects) 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 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 three studies, through 6 months following the last dose of DAPTACEL vaccine.

The incidence and severity of selected solicited local and systemic adverse events that occurred within 3 days following each dose of DAPTACEL vaccine are shown in Table 3. The incidence of redness, tenderness and swelling at the DAPTACEL injection site increased with the fourth and fifth doses, with the highest rates reported after the fifth dose. The incidence of redness, tenderness and swelling at the DAPTACEL injection site was similarly increased when DAPTACEL vaccine was given as a fifth dose of DTaP vaccine in Pentacel-primed children.

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 Vaccine

  Dose 1* Dose 2* Dose 3* Dose 4* Dose 5
DAPTACEL-primed* Pentacel-primed*
N= 1390-1406 % N= 1346-1360 % N = 1301-1312 % N= 1118-1144 % N = 473-481 % N = 936-981 %
Injection Site Reactions (DAPTACEL vaccine injection site)
Redness
   > 5 mm 6.2 7.1 9.6 17.3 35.8 20.2
  25 - 50 mm 0.6 0.5 1.9 6.3 10.4 6.8
   > 50 mm 0.4 0.1 0.0 3.1 15.8 6.6
Swelling
   > 5 mm 4.0 4.0 6.5 11.7 23.9 12.0
  25 - 50 mm 1.2 0.6 1.0 3.2 5.8 4.1
   > 50 mm 0.4 0.1 0.1 1.6 7.7 2.9
Tenderness†
  Any 48.8 38.2 40.9 49.5 61.5 50.0
  Moderate 16.5 9.9 10.6 12.3 11.2 7.4
  Severe 4.1 2.3 1.7 2.2 1.7 0.3
Increase in Arm Circumference‡
   > 5 mm - - - 30.1 38.3 28.6
  20 - 40 mm - - - 7.0 14.0 7.6
   > 40 mm - - - 0.4 1.5 1.2
Interference with Normal Activity of the Arm§
  Any - - - - 20.4 8.8
  Moderate 5.6 1.7
  Severe 0.4 0.0
Systemic Reactions
Fever**
    ≥ 38.0°C 9.3 16.1 15.8 10.5 6.1 4.6
   > 38.5-39.5°C 1.5 3.9 4.8 2.7 2.1 2.0
   > 39.5°C 0.1 0.4 0.3 0.7 0.2 0.2
Decreased Activity/Lethargy†,†
  Any 51.1 37.4 33.2 25.3 21.0 12.6
  Moderate 23.0 14.4 12.1 8.2 5.8 3.6
  Severe 1.2 1.4 0.6 1.0 0.8 0.4
Inconsolable Crying ‡,‡
  Any 58.5 51.4 47.9 37.1 14.1 7.2
  Moderate 14.2 12.6 10.8 7.7 3.5 1.9
  Severe 2.2 3.4 1.4 1.5 0.4 0.3
Fussiness/Irritability §§
  Any 75.8 70.7 67.1 54.4 34.9 22.9
  Moderate 27.7 25.0 22.0 16.3 7.5 5.3
  Severe 5.6 5.5 4.3 3.9 0.4 0.5
* In one U.S. study, children received four doses of DAPTACEL vaccine. A non-random subset of these children received a fifth dose of DAPTACEL vaccine in a subsequent study. A non-random subset of children previously vaccinated with 4 doses of Pentacel vaccine in previous clinical studies received a dose of DAPTACEL vaccine at 4-6 years of age as the fifth dose of DTaP vaccine in another clinical 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 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 in DAPTACEL-primed children, 0.2% of temperatures were measured rectally, 11.3% were measured axillary, and 88.4% were measured orally. For Dose 5 in Pentacel-primed children, 0.2% of temperatures were measured rectally, 0.5% were measured tympanically, 17% were measured axillary, and 81.7% 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 vaccine, of 1,454 subjects who received DAPTACEL vaccine, 5 (0.3%) subjects experienced a seizure within 60 days following any dose of DAPTACEL 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 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 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 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 US study in which DAPTACEL vaccine was administered as a fifth DTaP dose in DAPTACEL-primed subjects, within 30 days following the fifth consecutive dose of DAPTACEL vaccine, 1 (0.2%) subject reported 2 serious adverse events (bronchospasm and hypoxia). In the US study in which DAPTACEL vaccine was administered as a fifth DTaP dose in Pentacel-primed subjects, within 30 days following DAPTACEL, 4 (0.4%) subjects reported one or more serious adverse events (asthma and pneumonia; idiopathic thrombocytopenic purpura; vomiting; cellulitis not at the injection site). In these two studies, there were no reports of seizures within 30 days following DAPTACEL vaccine in either the DAPTACEL-primed subjects or Pentacel-primed subjects.

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 vaccine but containing twice the amount of detoxified PT and four times the amount of FHA (20 mcg detoxified PT and 20 mcg 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 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 one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to DAPTACEL vaccine.

Blood and Lymphatic Disorders

Lymphadenopathy

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, syncope

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 vaccine was administered concomitantly with one or more of the following US 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 vaccine is given at the same time as another injectable vaccine(s), the vaccines should be administered with different syringes and at different injection sites.

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 vaccine.

Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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