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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 Kinrix (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) Side Effects Center for a complete guide to possible side effects
Concomitant Vaccine Administration
In US clinical trials, KINRIX was administered concomitantly with the second dose of MMR vaccine (Merck & Co., Inc.); in one of these trials (Study 055), KINRIX was also administered concomitantly with varicella vaccine (Merck & Co., Inc.) [see Clinical Studies].
When KINRIX is administered concomitantly with other injectable vaccines, they should be given with separate syringes. KINRIX should not be mixed with any other vaccine in the same syringe or vial.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to KINRIX.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/19/2015
Additional Kinrix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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