2015年3月26日,赛诺菲巴斯德(Sanofi Pasteur)近日宣布，FDA已批准四联疫苗Quadracel（吸附无细胞百白破-灭活脊髓灰质炎，DTaP-IPV）用于4-6岁儿童的主动免疫，预防严重威胁健康的4大疾病：百日咳、白喉、破伤风、脊髓灰质炎。
赛诺菲巴斯德美国科学和医疗事务部副总裁David P. Greenberg医师表示，Quadracel此次获FDA批准，为医疗保健机构提供了一种新的联合疫苗，将潜在减少4-6岁儿童疫苗注射次数。
为保护婴儿和儿童免受这几种严重威胁健康的疾病，美国疾病控制和预防中心（CDC）推荐4-6岁儿童接种第5针百白破（DTaP）疫苗系列以及第4针灭活脊髓灰质炎病毒（IPV）疫苗系列。Quadracel疫苗可用于DTaP系列的第5针接种及IPV系列的第4或第5针。（附件：美国疾病控制和预防中心（CDC）发布的2015年美国《0-18岁人群免疫接种建议》）
Quadracel的获批，是基于一项关键性多中心随机对照III期研究的数据，该研究在此前已接种DAPTACEL和/或Pentacel（DTaP-IPV/Hib）的4-6岁儿童中开展，比较了Quadracel疫苗（DTaP-IPV）与DAPTACEL（DTaP）联合IPOL（IPV）疫苗的免疫原性和安全性。结果表明，Quadracel疫苗与分别单独接种DAPTACEL及IPOL疫苗具有相似的安全性及免疫原性。
关于Quadracel疫苗
Quadracel疫苗用于预防白喉，破伤风，百日咳，脊髓灰质炎和主动免疫。Quadracel疫苗的单剂量被批准用于4至6岁儿童使用
批准日期: 2015年3月25日；公司: Sanofi Pasteur
Quadracel(白喉和破伤风类毒素和无细胞的百日咳被吸附的和灭活的脊髓灰质炎病毒疫苗) 为肌肉注射悬液说明
美国初次批准: 20XX
适应证和用途
Quadracel是一种疫苗适用为对白喉，破伤风，百日咳和脊髓灰质炎主动免疫。Quadracel的单剂量被批准在4至6岁儿童中使用作为一个在白喉，破伤风，百日咳疫苗接种(DTaP)系列中第5剂，和作为在灭活的脊髓灰质炎病毒疫苗接种(IPV)系列，在接受4剂的Pentacel和/或DAPTACEL疫苗儿童中第4或第5剂。
剂量和给药方法
一个单次肌肉注射0.5mL。
剂型和规格
注射用悬液 ，在单剂量(0.5mL)小瓶中供应。
禁忌证
⑴ 对Quadracel任何组分，或任何白喉类毒素，破伤风类毒素，百日咳-含疫苗或灭活的脊髓灰质炎病毒疫苗后严重过敏反应(如，过敏反应)。
⑵ 一个以前百日咳-含疫苗的7天内脑病变与无其他可鉴定的原因。
⑶ 进行性神经疾病直至已确定一个治疗方案和条件已稳定化。
警告和注意事项
① 对有以下病史人们给予Quadracel 前仔细考虑获益和风险：
① 一个以前百日咳-含疫苗后48小时内发热 ≥40.5°C(≥105°F)，低渗-低反应性发作(HHE)或持续的，伤心欲绝的哭泣持续≥3小时。
② 一个以前百日咳-含疫苗后3天内癫痫发作。
⑵ 如一个以前含破伤风类毒素疫苗的接受者6周内发生Guillain-Barré综合征，给予任何破伤风类毒素-含疫苗，包括Quadracel的决定，应被根据潜在获益和可能风险仔细考虑.
不良反应
在临床研究中，最常见征求的注射部位反应是疼痛(>75%)，增加臂围(>65%)，红斑(>55%),和肿胀(>40%)。常见征求的全身反应是肌痛(>50%)，全身乏力(>35%)，和头痛(>15%)。
Quadracel 
Quadracel (Quad) protects against pertussis, diphtheria, tetanus and polio (cPDT polio)
Pertussis
•Children who get this disease have spells of violent coughing
•This cough can cause them to throw up or stop breathing for a short period of time
•The cough can last for weeks and make it hard for a child to eat, drink or even breathe
•Pertussis can cause pneumonia, brain damage and death
•Pertussis spreads very easily from infected person to others through coughing or sneezing
•Each year 1-3 deaths occur in Canada, mostly in young infants
Diptheria
•A serious disease of the nose, throat and skin
•Causes sore throat, fever and chills
•Can be complicated by breathing problems, heart failure and nerve damage
•It is passed to others through coughing and sneezing  
Tetanus
•Causes painful muscle cramping and convulsions (muscle spasms)
•Kills 2 out of 10 people who get it
•Can happen if dirt with the tetanus germ gets into a cut in the skin
•It does not spread from person to person
Polio
•Can cause nerve damage and paralysis (loss of function) in muscles used for breathing, talking, eating and walking
•Can make someone unable to walk and can even cause death
•Spread by coughing, sneezing or eating food or drinking water with the polio germ in it
Who should get Quadracel?
•Children should get the vaccine at 4-6 years of age, before starting school
Who should not get Quadracel?
•Children over 7 years of age
•People who have had a bad reaction to a vaccine or an ingredient in the vaccine
•If your child is taking medications or has any diseases that lower the immune system or increase bleeding, talk to your doctor or Public Health Nurse
•People with a history of Guillain- Barré Syndrome (muscle pain and weakness, or loss of muscle function)
•People who have had a bad reaction to an antibiotic called neomycin or polymyxin B 
Is Quadracel safe?
•Yes. You may have redness, swelling and warmth where the needle went in.
•Serious reactions to the vaccine are rare (e.g. hives, swelling of the mouth or throat or trouble breathing)
•Call your doctor if you or your child have any of these problems within 3 days of getting the needle:
◦Hives
◦Crying for more than 3 hours
◦Swelling of your face or mouth
◦Trouble breathing
◦Very pale color and tiredness
◦High fever (over 39° C or 102.2° F)
◦Convulsions (muscle spasms) or seizures
◦Other serious problems