美国FDA批准葛兰素史克公司的儿童新复方疫苗Kinrix（白喉、破伤风类毒素和吸附的无细胞百日咳以及灭活的脊髓灰质病毒疫苗）上市。本品是首个预防白喉、伤风、百日咳和脊髓灰质炎多种疫苗结合在一剂的疫苗。
临床研究显示，本品与分别接种白喉、破伤风类毒素和无细胞百日咳（DTaP）疫苗及灭活的脊髓灰质炎病毒（IPV）疫苗具有相同的防御作用。这些结果在纳入3 156例4～6岁儿童的随机对照的关键性Ⅲ期临床研究中得到证实。所有受试儿童先前接受4剂DTaP（INFANRIX）和3剂IPV（IPOL）接种。所有参加研究的儿童还接受美国已批准的麻疹、流行性腮腺炎和风疹（MMR）疫苗（M-M-RⅡ）接种。
本品含有美国医生使用多年的DTaP和IPV相同组分的疫苗。本品上市使4～6岁儿童只接种1次即可预防4种严重疾病。
在临床研究中，本品常见的不良反应是注射部位反应（疼痛、红肿），倦困，发热和食欲减退。先前对本品中任一成分及新霉素和多粘菌素Ｂ过敏者禁用。
DTaP-IPV vaccine for children
Company: 
GlaxoSmithKline
Vaccine (DTaP + IPV)
Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; may contain trace formaldehyde, neomycin, polymixin B, polysorbate 80.
Immunization against diphtheria, tetanus, pertussis, and polio: As the 5th dose in the DTaP immunization series and the 4th dose in the inactivated poliovirus vaccine (IPV) series in children 4? years of age (before 7th birthday) who previously received Infanrix (DTaP) and/or Pediarix (DTaP, HB, IPV) for the first 3 doses and Infanrix for the 4th dose.
Kinrix is a combination vaccine for children intended to provide protection against diphtheria, tetanus, pertussis and polio in one injection. The diphtheria, tetanus, and pertussis components of Kinrix are the same as those in Infanrix and Pediarix (also from GSK), and the poliovirus component is the same as that in Pediarix.
In a randomized, controlled study conducted in the US, 3,156 children 4 to 6 years of age who were previously immunized with four doses of DTaP and 3 doses of IPOL (from Sanofi Pasteur) were immunized with Kinrix. All children also were given the 2nd dose of MMR II (from Merck) concomitantly administered at separate sites. The control group was given Infanrix and IPOL vaccines. Levels of antibodies to the diphtheria, tetanus, pertussis and poliovirus antigens were measured in sera obtained immediately prior to immunization and one month after vaccination. Kinrix offered similar protection to its component vaccines given separately with a similar safety profile. It was non-inferior to Infanrix and IPV given separately, in terms of booster responses to DTaP antigens and post-vaccination antibody titers for anti-polio antibodies.
Not applicable.
<4 years or ≥7 years: not recommended. 4? years: One dose of 0.5mL in deltoid muscle.
Anaphylaxis associated with previous diphtheria, tetanus, pertussis, or polio vaccine. Encephalopathy within 7 days of previous pertussis vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy).
Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105癋 within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), or seizures (within 3 days) after previous pertussis vaccine: see literature. Seizure risk: may pretreat with antipyretic. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat.C): not applicable.
May give with concomitant vaccines (eg, MMR). Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Injection site pain, redness, local swelling, increase in arm circumference, drowsiness, fever, appetite loss.
Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.
Single-dose vials?0
Single-dose prefilled syringes? (without needles)
