Quadracel

Last updated on RxList: 7/3/2017
Quadracel Side Effects Center

Last reviewed on RxList 7/3/2017

Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) 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 and/or DAPTACEL vaccine. Common side effects of Quadracel include injection site reactions (swelling, redness, and increase in arm circumference), joint pain, general feeling of being unwell (malaise), and headache.

Quadracel is administered in a single dose intramuscular injection of 0.5 mL. Quadracel may interact with immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant before receiving Quadracel. Consult your doctor before breastfeeding.

Our Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

25 Ways to Stay Well Abroad in Pictures See Slideshow
Quadracel Consumer Information

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has:

  • irritability, crying for an hour or longer;
  • very high fever; or
  • extreme drowsiness, fainting.

Common side effects may include:

  • drowsiness, not feeling well;
  • headache, muscle pain;
  • loss of appetite; or
  • redness, pain, tenderness, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Quadracel Professional Information

SIDE EFFECTS

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%).

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), 3372 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 2733 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 vacination 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 Vaccinesa

Injection Site Reactions Quadracel
(Nb = 2500-2689)
DAPTACEL + IPOL
(Nb = 598-603)
Quadracel site DAPTACEL or IPOL site
Painc 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 circumferenced 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 swellinge Any 1.5 1.3
Systemic Reactions
Myalgiaf Any 53.8 52.6
Grade 1 36.0 33.5
Grade 2 15.8 16.3
Grade 3 1.9 2.8
Malaisef Any 35.0 33.2
Grade 1 21.7 18.7
Grade 2 10.6 11.1
Grade 3 2.6 3.3
Headachef 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
a ClinicalTrials.gov Identifier: NCT01346293.
b N = The number of subjects with available data.
c Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities.
d 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.
e Swelling of the injected limb including the adjacent joint (i.e., elbow and/or shoulder) as compared to baseline.
f Grade 1: No interference with activity, Grade 2: Some interference with activity, Grade 3: Significant; prevents daily activity.

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 (3/2733) 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 (21/2733) who received Quadracel and 0.5% of subjects (3/621) who received DAPTACEL + IPOL vaccines, none of which were assessed as related to vaccination.

Postmarketing Experience

The following adverse events have been spontaneously reported, during the post-marketing use of Quadracel outside the US, in infants and children from 2 months through 6 years of age. Because these events are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or establish a causal relationship to vaccine exposure. This list includes adverse events based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Quadracel.

Immune System Disorders

Anaphylactic reaction, hypersensitivity and allergic reactions (such as rash, urticaria, dyspnea)

Psychiatric Disorders

Screaming

Nervous System Disorders

Somnolence, convulsion, febrile convulsion, HHE, hypotonia

Cardiac Disorders

Cyanosis

Vascular Disorders

Pallor

General Disorders and Administration Site Conditions

Listlessness

Injection site reactions (including inflammation, mass, sterile abscess, and edema)

Large injection site reactions ( > 50 mm), including limb swelling which may extend from the injection site beyond one or both joints

Infections and Infestations Injection site cellulitis, injection site abscess

Read the entire FDA prescribing information for Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

© Quadracel Patient Information is supplied by Cerner Multum, Inc. and Quadracel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors