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Kinrix

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Kinrix

Kinrix

SIDE EFFECTS

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 3,537 children were vaccinated with a single dose of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) in 3 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (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 (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (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 (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) 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 (Study 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 (Study 047 and 048), parents/guardians were actively queried about changes in the child's the occurrence of serious adverse events, throughhealth status, 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 Vaccination* With KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or Separate Concomitant Administration of INFANRIX and IPV When Coadministered With MMR Vaccine (Study 048) (Total Vaccinated Cohort)

  KINRIX INFANRIX + IPV
Local N = 3,121-3,128 N = 1,039-1,043
Pain, any 57.0 53.3
Pain, grade 2 or 3 13.7 12.0
Pain, grade 3 1.6 0.6
Redness, any 36.6 36.6
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, any 26.0 27.0
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, any 19.1 17.5
Drowsiness, grade 3|| 0.8 0.8
Fever, ≥ 99.5° F 16.0 14.8
Fever, >100.4° F 6.54.4
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 3 0.8 0.6
IPV manufactured by Sanofi Pasteur SA. MMR vaccine manufactured by 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.
*Within 4 days of vaccination defined as day of vaccination and the next 3 days.
Local reactions at the injection site for KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or INFANRIX.
Statistically higher than comparator group (p < 0.05).
Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing normal daily activities.
|| Grade 3 defined as preventing normal daily activities.
Grade 3 defined as not eating at all.

In Study 048, KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) 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 (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [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 (Study 046, 047, and 048), in which all subjects received concomitant MMR vaccine (US licensed MMR vaccine [Merck & Co., Inc.] in Study 047 and 048; non-US licensed MMR vaccine in Study 046), 3 subjects (0.1% [3/3,537]) who received KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) reported serious adverse events (dehydration and hypernatremia; cerebrovascular accident; dehydration and gastroenteritis) and 4 subjects (0.3% [4/1,434]) who received INFANRIX and IPV (Sanofi Pasteur SA) reported serious adverse events (cellulitis; constipation; foreign body trauma; fever without identified etiology).

Postmarketing Experience

In addition to reports in clinical trials, the following adverse events, for which a causal relationship to components of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is plausible, have been reported since market introduction of DTaP-IPV manufactured by GlaxoSmithKline outside the U.S. 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.

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

DRUG INTERACTIONS

Concomitant Vaccine Administration

In clinical trials, KINRIX was administered concomitantly with the second dose of MMR vaccine [see Clinical Studies].

Data are not available on concomitant use of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) and varicella vaccine.

When KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is administered concomitantly with other injectable vaccines, they should be given with separate syringes. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) should not be mixed with any other vaccine in the same syringe or vial.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) .

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

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