Medical Editor: John P. Cunha, DO, FACOEP
Kinrix (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is a vaccine used to help prevent the diseases of diphtheria, pertussis, tetanus, and polio in children who are ages 4 through 6 years (before the 7th birthday) who have received prior vaccination with a DTaP and IPV series. Common side effects of Kinrix include injection site reactions (pain, swelling, tenderness, or redness), mild fever, drowsiness, tiredness, headache, fussiness or crying, nausea, and loss of appetite.
Kinrix vaccine is administered as a 0.5-mL dose by intramuscular injection, usually into the deltoid muscle of the upper arm. Kinrix may interact with steroids, medicines to treat or prevent organ transplant rejection, and medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you or your child use and all other vaccines recently received. During pregnancy, Kinrix should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Our Kinrix (diptheria 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.
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. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots 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. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these 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 any of these serious side effects:
- extreme drowsiness, fainting;
- fussiness, irritability, crying for an hour or longer;
- seizure (black-out or convulsions); or
- high fever.
Less serious side effects may include:
- redness, pain, tenderness, or swelling where the shot was given;
- mild fussiness or crying;
- low fever; or
- loss of appetite.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
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 with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.
A total of 4,013 children were vaccinated with a single dose of KINRIX in 4 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (containing ≤ 2.5 mg 2-phenoxyethanol per dose as preservative).
The primary study (Study 048), conducted in the United States, was a randomized, controlled clinical trial in which children 4 to 6 years of age were vaccinated with KINRIX (N = 3,156) or control vaccines (INFANRIX and IPOL® vaccine [IPV, Sanofi Pasteur SA]; N = 1,053) as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses of IPOL. Subjects also received the second dose of US-licensed measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.) administered concomitantly, at separate sites.
Data on adverse events were collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with KINRIX or control vaccines (i.e., day of vaccination and the next 3 days). The reported frequencies of solicited local reactions and general adverse events in Study 048 are presented in Table 1.
In 3 studies (Studies 046, 047, and 048), children were monitored for unsolicited adverse events, including serious adverse events, that occurred in the 31-day period following vaccination and in 2 studies (Studies 047 and 048), parents/guardians were actively queried about changes in the child's health status, including the occurrence of serious adverse events, through 6 months post-vaccination.
Table 1: Percentage of Children 4 to 6 Years of Age
Reporting Solicited Local Reactions or General Adverse Events Within 4 Days of
Vaccinationa With KINRIX or Separate Concomitant Administration of
INFANRIX and IPV When Coadministered With MMR Vaccine (Study 048) (Total
N = 3,121-3,128
|INFANRIX + IPV
N = 1,039-1,043
|Pain, grade 2 or 3||13.7||12.0|
|Pain, grade 3 d||1.6c||0.6|
|Redness, ≥ 50 mm||17.6||20.0|
|Redness, ≥ 110 mm||2.9||4.1|
|Arm circumference increase, any||36.0||37.8|
|Arm circumference increase, > 20 mm||6.9||7.4|
|Arm circumference increase, > 30 mm||2.4||3.2|
|Swelling, ≥ 50 mm||10.2||11.5|
|Swelling, ≥ 110 mm||1.4||1.8|
|General||N = 3,037-3,120||N = 993-1,036|
|Drowsiness, grade 3e||0.8||0.8|
|Fever, ≥ 99.5 °F||16.0||14.8|
|Fever, > 100.4°F||c .5 6.||4.4|
|Fever, > 102.2°F||1.1||1.1|
|Fever, > 104°F||0.1||0.0|
|Loss of appetite, any||15.5||16.0|
|Loss of appetite, grade 3f||0.8||0.6|
|IPV = inactivated poliovirus vaccine (Sanofi Pasteur SA);
MMR = measles, mumps, and rubella vaccine (Merck & Co., Inc.).
Total Vaccinated Cohort = all vaccinated subjects for whom safety data were available.
N = number of children with evaluable data for the events listed.
a Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b Local reactions at the injection site for KINRIX or INFANRIX.
c Statistically higher than comparator group (P < 0.05).
d Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing normal daily activities.
e Grade 3 defined as preventing normal daily activities.
f Grade 3 defined as not eating at all.
In Study 048, KINRIX was non-inferior to INFANRIX with regard to swelling that involved > 50% of the injected upper arm length and that was associated with a > 30 mm increase in mid-upper arm circumference within 4 days following vaccination (upper limit of two-sided 95% Confidence Interval for difference in percentage of KINRIX [0.6%, n = 20] minus INFANRIX [1.0%, n = 11] ≤ 2%).
Serious Adverse Events
Within the 31-day period following study vaccination in 3 studies (Studies 046, 047, and 048), in which all subjects received concomitant MMR vaccine (US-licensed MMR vaccine [Merck & Co., Inc.] in Studies 047 and 048; non-US-licensed MMR vaccine in Study 046), 3 subjects (0.1% [3/3,537]) who received KINRIX reported serious adverse events (dehydration and hypernatremia; cerebrovascular accident; dehydration and gastroenteritis) and 4 subjects (0.3% [4/1,434]) who received INFANRIX and inactivated poliovirus vaccine (Sanofi Pasteur SA) reported serious adverse events (cellulitis, constipation, foreign body trauma, fever without identified etiology).
In addition to reports in clinical trials, the following adverse events, for which a causal relationship to components of KINRIX is plausible, have been reported since market introduction. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.
General Disorders and Administration Site Conditions: Injection site vesicles.
Nervous System Disorders: Syncope.
Skin and Subcutaneous Tissue Disorders: Pruritus.
Additional adverse events reported following postmarketing use of INFANRIX, for which a causal relationship to vaccination is plausible, are: Allergic reactions, including anaphylactoid reactions, anaphylaxis, angioedema, and urticaria; apnea; collapse or shock-like state (hypotonic-hyporesponsive episode); convulsions (with or without fever); lymphadenopathy; and thrombocytopenia.
Read the entire FDA prescribing information for Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)