Vaccine Information: QUADRACEL

QUADRACEL- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, bordetella pertussis fimbriae 2/3 antigen, poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated) and poliovirus type 3 antigen (formaldehyde inactivated) injection, suspension
Sanofi Pasteur Inc.

1 INDICATIONS AND USAGE

Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine] and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

Just before use, shake the vial well, until a uniform, white, cloudy suspension results. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the product should not be administered.

Using a sterile needle and syringe and aseptic technique, withdraw and administer a 0.5 mL dose of Quadracel vaccine intramuscularly into the deltoid muscle of the upper arm. Discard unused portion.

Quadracel should not be combined through reconstitution or mixed with any other vaccine.

3 DOSAGE FORMS AND STRENGTHS

Quadracel is a suspension for injection in 0.5 mL single-dose vials.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel [see Description (11)] or following any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine, is a contraindication to administration of Quadracel.

4.2 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 Quadracel.

4.3 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 Quadracel. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.

5 WARNINGS AND PRECAUTIONS

5.1 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.

5.2 Adverse Reactions Following Prior Pertussis Vaccination

If any of the following events have occurred within the specified period after administration of a pertussis vaccine, the decision to administer Quadracel should be based on careful consideration of benefits and 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 ≥3 hours within 48 hours.
  • Seizures with or without fever within 3 days.

5.3 Guillain-Barré Syndrome

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Quadracel, should be based on careful consideration of the potential benefits and possible risks.

5.4 Limitations of Vaccine Effectiveness

Vaccination with Quadracel may not protect all individuals.

5.5 Altered Immunocompetence

If Quadracel is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Drug Interactions (7.2).]

6 ADVERSE REACTIONS

In a clinical study, the most common solicited injection site reactions were pain (>75%), increase in arm circumference (>65%), erythema (>55%), and swelling (>40%). Common solicited systemic reactions were myalgia (>50%), malaise (>35%), and headache (>15%).

6.1 Clinical Trials Experience

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.

In a randomized, controlled, multicenter study conducted in the US and Puerto Rico (Study M5I02; ClinicalTrials.gov Identifier: NCT01346293), 3,372 children, 4 to 6 years of age, who had received 4 doses of DAPTACEL and/or Pentacel vaccine(s) received Quadracel, or DAPTACEL + IPOL (Poliovirus Vaccine Inactivated) vaccines administered concomitantly but at separate sites. Subjects also received Measles, Mumps, and Rubella Virus Vaccine Live (MMR) (Merck & Co., Inc.) and Varicella Virus Vaccine Live (Varicella vaccine) (Merck & Co., Inc.) administered concomitantly at separate sites. Safety was evaluated in 2,733 subjects who received Quadracel and 621 subjects who received DAPTACEL + IPOL vaccines.

Among these subjects, 51.5% were male, 48.5% were female, 75.7% were Caucasian, 8.6% were Black, 7.9% were Hispanic, 0.9% were Asian, and 7.8% were of other racial/ethnic groups. The mean age for both groups was 4.4 years and the ratio of male to female subjects and ethnicity were balanced between both groups.

Solicited injection site reactions and systemic reactions were collected daily for 7 days following vaccination, via diary cards. Participants were monitored for unsolicited adverse events for 28 days and serious adverse events (SAEs) for 6 months after vaccination.

Solicited Adverse Reactions

The incidence and severity of solicited injection site and systemic adverse reactions that occurred within 7 days after vaccination in each study group are shown in Table 1.

Table 1: Percentage of Children 4 through 6 years of Age with Solicited Adverse Reactions by Intensity Within 7 Days of Vaccination with Quadracel or Concomitant but Separate DAPTACEL and IPOL vaccines Co-Administered with MMR and Varicella Vaccines *
Quadracel(N = 2,500-2,689) DAPTACEL + IPOL(N = 598-603)
*
ClinicalTrials.gov Identifier: NCT01346293.
N = The number of subjects with available data.
Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities.
§
Grade 1: >0 to <25 mm increase over pre-vaccination measurement, Grade 2: ≥25 to ≤50 mm increase over pre-vaccination measurement, Grade 3: >50 mm increase over pre-vaccination measurement.
Swelling of the injected limb including the adjacent joint (i.e., elbow and/or shoulder) as compared to baseline.
#
Grade 1: No interference with activity, Grade 2: Some interference with activity, Grade 3: Significant; prevents daily activity.
Injection Site Reactions Quadracel site DAPTACEL or IPOL site
Pain Any 77.4 76.5
Grade 1 56.4 54.9
Grade 2 19.0 18.6
Grade 3 2.0 3.0
Change in limb circumference § Any 68.1 65.1
Grade 1 59.8 58.6
Grade 2 8.2 6.5
Grade 3 0.2 0.0
Erythema Any 59.1 53.4
>0 to <25 mm 31.6 31.8
≥25 to <50 mm 9.5 9.6
≥50 mm 18.0 11.9
Swelling Any 40.2 36.4
>0 to <25 mm 23.5 23.1
≥25 to <50 mm 8.1 6.1
≥50 mm 8.6 7.1
Extensive limb swelling Any 1.5 1.3
Systemic Reactions
Myalgia # Any 53.8 52.6
Grade 1 36.0 33.5
Grade 2 15.8 16.3
Grade 3 1.9 2.8
Malaise # Any 35.0 33.2
Grade 1 21.7 18.7
Grade 2 10.6 11.1
Grade 3 2.6 3.3
Headache # Any 15.6 16.6
Grade 1 11.9 11.9
Grade 2 3.1 4.0
Grade 3 0.6 0.7
Fever Any 6.0 6.9
≥38.0°C to ≤38.4°C 2.6 3.0
≥38.5°C to ≤38.9°C 2.1 1.8
≥39.0°C 1.3 2.0

Serious Adverse Events

In Study M5I02, within 28 days following vaccination with Quadracel, or DAPTACEL + IPOL vaccines, and concomitant MMR and varicella vaccines, 0.1% of subjects (3/2,733) in the Quadracel group experienced a serious adverse event. During the same time period, 0.2% subjects (1/621) in the DAPTACEL + IPOL group experienced a SAE. Within the 6-month follow-up period after vaccination, SAEs were reported in 0.8% of subjects (21/2,733) who received Quadracel and 0.5% of subjects (3/621) who received DAPTACEL + IPOL vaccines, none of which were assessed as related to vaccination.

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