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Quadracel Approved: Take the PI Test


Find out what you know about on- and off-label use of the newest DTaP/IPV combination vaccine based on this short scenario.

Editor's note: This an updated version of the original article which first appeared here in January, 2017.

Sanofi Pasteur announced the release of the new combination vaccine Quadracel, a mixture of DTaP and IPV for use in the 4- to 6-year-old child. This product will compete with GSK’s Kinrex, also a combination of DTaP and IPV with the same age indication.

The press and lawyers like to talk about “off-label” use of FDA-approved medicines and vaccines. The package insert that comes with every medicine and vaccine is rarely read in full by practicing physicians, yet we may be forced to defend ourselves in a court of law explaining why we decided to use the medicine/vaccine in a manner different from what was clearly recommended by the manufacturer. Those recommendations, of course, are usually supported by clinical studies.

Let’s see if you can pick out the off-label use of Quadracel in the following scenario:

[[{"type":"media","view_mode":"media_crop","fid":"55917","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_882144736682","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"7018","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 221px; width: 300px; float: right;","title":" ","typeof":"foaf:Image"}}]]A 6-year-old in your office will be going to public school for the first time this year and is only partially vaccinated. He had a fever to 105°F after his 6th-month set of shots and mom decided to defer any further pertussis vaccinations until now. He is otherwise up-to-date including 4 doses of IPV all given before age 4 years. He needs to receive a DTaP and polio today per your state’s requirements and your nurse administers a Quadracel in his left thigh at mom’s request since he is very thin and his deltoid looks too small to her. After the shot is given, the mother mentioned that the child had woken up that morning with a temperature of 101°F and a sore throat.

Which of the following are off-label usages of Quadracel in this child? (More than one answer may be correct.) 

Giving it to a child: 

A. ... with a fever

B. ... in the thigh instead of the deltoid

C. ... who had been given Pediarix as an infant instead of Pentacel and/or DAPTACEL  

D. ... who had already received 4 doses of IPV

E. ... who developed fever of ≥105°F with a previous pertussis vaccine

F. None of the above are off-label uses

Answer and discussion>>


Image ©Luiscar74/Shutterstock.com



A is not off-label. Nothing in the Quadracel PI addresses giving the vaccine to a sick or febrile child. The ACIP suggests deferring vaccines in moderately ill children. A fever is not a contraindication for vaccine administration.

B is off-label. The Quadracel package insert says the vaccine should be given in the deltoid muscle, presumably since this is how it was given in the clinical trials before approval. The ACIP is happy as long as it is given IM.

C is off-label also. Pediarix and Pentacel have different pertussis antigens in them and efficacy studies have only looked at children receiving the same vaccine for all doses. The ACIP encourages the use of the same pertussis vaccine for the complete series, but does say you can “mix and match” the different pertussis vaccines if needed.

D is on label. Quadracel can be used for the 4th or 5th dose of IPV.

E is on label.  However, giving Quadracel to a child in whom fever developed after a previous pertussis vaccine is under the “warnings and precautions” section of the PI meaning that the provider and parent need to decide if the benefit of administration outweighs the risk. It would not be inappropriate for a provider to offer a medical exemption from further pertussis vaccinations in this scenario. It also would not be inappropriate to give the vaccine after discussion with the parent.


Quadracel [package insert]. Swiftwater, Penn: Sanofi Pasteur Inc; 2016.

Liang J, Wallace G, Mootrey G. Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine and Guidance for Use as a Booster Dose. Morbid Mortal Weekly Rep. 2015;64:948-949


For the next article in the Patient Care Pediatric Vaccination Special Report, please click below.
When to Say "No" to MMR Vaccination



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