Quadracel Vaccine
Quadracel is a shot that can be given as the last dose in the DTaP (diphtheria, tetanus, pertussis) or IPV (polio) series of immunizations. The most serious side effects include high fever, seizure, brain inflammation, and deadly allergic reactions.
What is DTaP?
What is IPV?
When is each shot of Quadracel?
Do I need more shots?
What are the most common side effects of Quadracel?
Who should not get Quadracel?
What are severe side effects of Quadracel?
What other side effects have been reported?
What else is in Quadracel?
Where can I get more information?
What is Quadracel?
Quadracel® is a DTaP/IPV vaccine against diphtheria, tetanus, pertussis, and polio. It is made by Sanofi and it was approved in 2015.
What is DTaP?
Quadracel is only approved for the fifth dose in the DTaP series of vaccines against diphtheria, tetanus, and pertussis (whooping cough). DTaP is given in a series of 5 shots, one shot at each of the following ages: 2 months, 4 months, 6 months, 5-18 months, and 4-6 years old.
What is IPV?
Quadracel can be used for the last dose in the IPV (Inactivated Polio Virus) immunization schedule. Four doses of IPV are usually given at the ages of 2 months, 4 months, 6-18 months, and 4 to 6 years old.
When is each shot of Quadracel?
A single dose of Quadracel is approved for children between 4 and 6 years old. Quadracel can be given as the 5th dose in the DTaP series. Quadracel can also be given as the 4th or 5th dose in the IPV series for children who have already had 4 doses of Pentacel (DTaP/IPV/Hib) and/or Daptacel (DTaP).
Will I need more shots?
No. One shot of Quadracel is used as the final dose to complete the DTaP and IPV series of vaccines. Most adults will not need any more vaccines against polio. However, DTaP booster shots (Tdap and Td vaccines) are needed from the ages of 12-64 years old.
What are the most common side effects of Quadracel?
In clinical studies, the most common side effects where the injection was administered were pain (75%), increased arm circumference (65%), redness (55%), and swelling (40%). Other common side effects were muscle pain (50%), malaise (35%), headache (15%), and fever (6%). About 1.5% of children developed extensive swelling of the limb where the shot was given, including the elbow and/or shoulder.
What is the risk of fever from Quadracel?
Approximately 6% of children develop fevers after Quadracel. The risk was as follows: Fever over 100.4°F (2.5%), Fever over 101.3°F (2.1%), and 102.2°F (1.3%).
Parents should carefully consider the risks and benefits of giving Quadracel to children with a history of fever over 105°F within 48 hours after a previous vaccine containing pertussis (whooping cough).
Who should not get Quadracel?
Children should not get Quadracel if they had a severe allergic reaction to any ingredient in Quadracel (see below for a complete list) or a previous vaccine against diphtheria, tetanus, pertussis, or polio.
Quadracel is contraindicated in children with progressive neurological disorders (infantile spasms, uncontrolled epilepsy, etc.).
Quadracel is also contraindicated in children who developed encephalopathy (coma, decreased consciousness, seizures, etc.) within 7 days of a previous vaccine against pertussis.
What are severe side effects of Quadracel?
- Allergic reaction
- Anaphylaxis
- Brachial neuritis
- Coma
- Collapse or shock-like state
- Crying lasting 3 hours or more
- Death
- Decreased consciousness
- Encephalopathy (brain inflammation)
- Extensive swelling of the limb
- Guillain-Barré Syndrome (GBS)
- Hypotonic-Hyporesponsive Episode (HHE)
- Nerve damage
- Progressive neurological disorder
- Seizures
What other side effects have been reported?
Quadracel has been linked to spontaneous reports of other side effects. It is unknown if Quadracel actually caused these injuries, but the following is a list of possible risks:
- Convulsion
- Cyanosis (“Blue Baby Syndrome”)
- Hypersensitivity (rash, hives, itching, trouble breathing)
- Hypotonia (“Floppy Baby Syndrome”)
- Injection-site abscess
- Low oxygen in the bloodstream
- Muscle weakness
- Paleness
- Screaming
- Skin infection (cellulitis)
- Sleepiness
What else is in Quadracel?
Each 0.5-mL dose of Quadracel has 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, Polysorbate 80 (10 ppm), formaldehyde (5 mcg), glutaraldehyde (50 ng), and antibiotics neomycin and polymyxin B (less than 4 pg).
The following is a complete list of ingredients in Quadracel:
Modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, formaldehyde, ammonium sulfate, aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, MRC-5 cells, normal human diploid cells, CMRL 1969 medium supplemented with calf serum, Medium 199 without calf serum, 2-phenoxyethanol, polysorbate 80, glutaraldehyde, neomycin, polymyxin B sulfate.
