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.
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).
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.
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.
Quadracel is a suspension for injection in 0.5 mL single-dose vials.
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.
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.
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.
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.
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.
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.
Vaccination with Quadracel may not protect all individuals.
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)].
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%).
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. The poliovirus component (poliovirus types 1, 2, and 3) of this formulation of Quadracel is grown in Vero cells [see Description (11)].The clinical study data in this section were accrued with a Quadracel formulation in which poliovirus component was grown in MRC-5 cells.
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.
|Quadracel(N †= 2,500-2,689)||DAPTACEL + IPOL(N † = 598-603)|
|Injection Site Reactions||Quadracel site||DAPTACEL or IPOL site|
|Change in limb circumference §||Any||68.1||65.1|
|>0 to <25 mm||31.6||31.8|
|≥25 to <50 mm||9.5||9.6|
|>0 to <25 mm||23.5||23.1|
|≥25 to <50 mm||8.1||6.1|
|Extensive limb swelling ¶||Any||1.5||1.3|
|≥38.0°C to ≤38.4°C||2.6||3.0|
|≥38.5°C to ≤38.9°C||2.1||1.8|
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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