DTaP Vaccines

The DTaP Vaccines

There are two vaccines listed in the MDH Vaccine Product Summary for DTaP: DAPTACEL and Infanrix.  Two other vaccines that include DTaP are pentavalent vaccines (5 vaccines in one shot), are Pediarix, which includes the DTaP, IPV (Polio), and Hep B, and Pentacel, which includes DTaP, IPOL (Polio) and Hib.


DAPTACEL (DTaP) – Sanofi Pasteur – Package Insert                                              https://www.vaccineshoppe.com/image.cfm?doc_id=11179&image_type=product_pdf

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.  (Page 2)

Clinical studies compared DAPTACEL, DT, and DPT. The “placebo” was DT (see p. 2-5 under Adverse Reactions).

Post-marketing data shows reports of lymphadenopathy, cyanosis, nausea, diarrhea, local injections reactions, hypersensitivity, allergic reactions, anaphylactic reaction, convulsions (febrile, grand mal, and partial), HHE hypotonia, somnolence, syncope and screaming. (See p. 4)

Interesting note on Pertussis on page 5: 

Pertussis (whooping cough) is a respiratory disease caused by B pertussis. This Gram-negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined. 

DAPTACEL ingredients: Aluminum Phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, modified Mueller's growth medium, modified Mueller-Miller casamino acid medium (without beef heart infusion) Dimethyl 1-beta-ceylodextrin, ammonium sulfate

Infanrix (DTaP)

Infanrix (DTaP) – GlaxoSmithKline - Package Insert  https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm124514.pdf

Under contraindications and warnings, it is acknowledged that encephalopathy can occur within 7 days following a pertussis vaccine and Guillian-Barre Syndrome can occur within 6 weeks following tetanus vaccines.  When this has happened Infanrix is contraindicated. (4.2, 5.1 – p.3)


It is also acknowledged that syncope can occur following the administration of Infanrix, and apnea can occur in premature infants with this vaccine. (5.3, 5.6 – p.4)

In the one clinical study that used a control, INFANRIX was compared with Whole-Cell DTP Vaccine (See Table 4, p. 11). 

All other studies cited administered multiple vaccines and followed subjects for a short period of time.  In a US study infants received INFANRIX, ENGERIX-B, IPV, Hib, and PCV7 concomitantly and followed for only 4 days.  Pain, redness and swelling, fever, drowsiness, irritability/fussiness and loss of appetite were common symptoms.  (p. 5-7)

In the previous Infanrix package insert, a study of 29,000 kids recorded 14 deaths, 9 of which were SIDS. They compare rates of SIDS in two studies with the rate of SIDS in the U.S., attempting to show that by chance alone the kids in the study could have died of SIDS.  However, kids in the U.S. are highly vaccinated, so this comparison tells us nothing.  Again, it is simply like every other vaccine safety study, comparing vaccinated kids with vaccinated kids.

Postmarketing Reports:  bronchitis, respiratory tract infection, anaphylactic reaction, hypersensitivity, encephalopathy, headache, hypotonia syncope, ear pain, cyanosis, apnea, cough, angioedema, erythema, pruritus, rash, urticaria, fatigue, injection site reaction, Sudden Infant Death Syndrome. (p. 12)

“The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no well established serological correlate of protection for pertussis.” (page 14-15)

INFANRIX Ingredients: Fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80)

Pediarix (DTaP, IPV, Hep B)

Pediarix (DTaP, IPV, Hep B) – GlaxoSmithKline – Package Insert

Warnings: “Administration of PEDIARIX is associated with higher rates of fever relative to separately administered vaccines.” (Page 4)

“Syncope (fainting) can occur in association with administration of injectable vaccines, including PEDIARIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.” (Page 4)

“If any of the following events occur in temporal relation to receipt of a vaccine containing a pertussis component, the decision to give any pertussis-containing vaccine, including PEDIARIX, should be based on careful consideration of the potential benefits and possible risks:

 • Temperature of ≥40.5o C (105o F) within 48 hours not due to another identifiable cause
 • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours 
 • Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours
 • Seizures with or without fever occurring within 3 days”

A German safety study compared infants receiving Pediarix and Hib to infants receiving Hib and OPV.  A U.S. study compared infants receiving Pediarix (DTaP, Hep B, IPV) to infants receiving Infanrix (DTaP) and Engerix B (Hep B).  In addition both groups also received Hib and PCV.

There were 5 deaths in the clinical trials in the Pediarix groups including 2 cases of SIDS.  They compared the rates of SIDS in their trials to the rates of SIDS in the U.S., and stated that “By chance alone, some cases of SIDS can be expected to follow receipts of pertussis-containing vaccines.  (Of course kids in the U.S. are the most highly vaccinated population in the world – which is the worst “control group” that you could compare to.)

In addition to seizures in both the U.S. and German studies, in the U.S. study they noted a significant onset of chronic illness in both the test and control groups (4% and 3% respectively) which included asthma and diabetes. 

Adverse Reactions: See pages 5-11 of Product insert.  Many of the reactions were listed above under INFANRIX and ENGERIX, with additional reactions.

Pediarix Ingredients: formaldehyde, glutaraldehyde, aluminum hydroxide, aluminum phosphate, lactalbumin hydrolysate, polysorbate 80, neomycin sulfate, polymyxin B, yeast protein, calf serum, Fenton medium (containing bovine extract), modified Latham medium (derived from bovine casein), modified Stainer-Scholte liquid medium, Vero (monkey kidney) cells

Pentacel (DTaP, IPOL, HIB)

Pentacel (Pentavalent vaccine) – DTaP-IPOL/Hib – Sanofi Pasteur

Package Insert

Encephalopathy (eg, 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 Pentacel vaccine. (p.6)
(In other words, if a DTaP containing shot caused brain damage, don’t give the child another one).

The most frequent (>50% of participants) systemic reactions following any dose were fussiness/irritability and inconsolable crying. The most frequent (>30% of participants) injection site reactions following any dose were tenderness and increased circumference of the injected arm. (Adverse Reactions – p.8)

Safety Studies used vaccine control groups and/or concomitantly administered vaccines. (Table 1 – p.10)

Pentacel ingredients: aluminum phosphate, polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxethanol, neomycin, polymyxin B sulfate, Mueller’s Growth Medium, Mueller-Miller casamino acid medium (without beef heart infusion), Stainer-Scholte medium (modified by the addition of casamino acids and dimethyl-beta-cyclodextrin), MRC-5 (human diploid) cells, CMRL 1969 medium (supplemented with calf serum), ammonium sulfate, and medium 199              


Pentavalent Vaccine – DTaP-IPOL-Hib

Bhutan – Introduced July 2009, withdrawn in 2 months following 8 deaths.

Pakistan – Introduced Nov. 2008 – 3 deaths (1 within ½ hour, 2 within 12-14 hrs.)


Sri Lanka – Introduced Jan. 2008, withdrawn April 2008 after 5 deaths.

Kerala - 2012 - 3 deaths

Haryana - 2012 -1 death

Vietnam - November 2012 - 3 deaths - PV vaccine use terminated


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