Dalvi Shashank, Kulkarni Prasad S, Phadke M A, More S S, Lalwani Sanjay K, Jain Dipty, Manglani Mamta, Garg B S, Doibale Mohan K, Deshmukh C T
a Government Medical College ; Aurangabad , Maharashtra , India.
Hum Vaccin Immunother. 2015;11(4):901-7. doi: 10.1080/21645515.2015.1010953.
Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepB+Hib vaccine. Three doses of DTwP-HepB+Hib vaccine (Pentavac, Serum Institute of India Ltd) or Tritanrix-HB+Hib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %-33.6 %; redness 18.1 %-17.2 %; swelling 23.7 %-22.4 %; induration 12.8 % -13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %-2.2 %; drowsiness 3.3 %-3.4 %; fever 14.0 %-11.2 %; irritability 28.1 %-25.4 %; loss of appetite 6.6 %-5.6 %; persistent crying 17.7 %-15.7 %; vomiting 3.5 %-3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepB+Hib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.
乙型肝炎和b型流感嗜血杆菌（Hib）感染是包括印度在内的发展中国家的主要公共卫生问题。因此，已研发出包含白喉、破伤风、百日咳、重组乙型肝炎和Hib结合疫苗的联合疫苗。在此，我们报告一项IV期研究，该研究评估了一种新型白喉、破伤风、百日咳、乙型肝炎和Hib联合疫苗（DTwP-HepB+Hib）的安全性和反应原性。以2:1的比例给6、10和14周龄的婴儿接种三剂DTwP-HepB+Hib疫苗（Pentavac，印度血清研究所）或白百破-乙型肝炎+Hib（葛兰素史克公司）。对受试者进行随访直至第三剂接种后一个月以进行安全性评估。通过结构化日记记录不良事件，并在每次访视时进行体格检查。该研究共纳入1510名婴儿。两种疫苗均引起注射部位局部和全身反应，两组的发生率相似。局部自发反应的发生率为：压痛35.9%-33.6%；发红18.1%-17.2%；肿胀23.7%-22.4%；硬结12.8%-13.7%。全身自发反应的百分比为：腹泻2.2%-2.2%；嗜睡3.3%-3.4%；发热14.0%-11.2%；易激惹28.1%-25.4%；食欲不振6.6%-5.6%；持续性哭闹17.7%-15.7%；呕吐3.5%-3.0%。疫苗未引起严重不良事件。新型DTwP-HepB+Hib联合疫苗在印度婴儿中的安全性与进口疫苗相似。
