Adis, 41 Centorian Drive, Mairangi Bay, Auckland, New Zealand.
BioDrugs. 2010 Oct 1;24(5):299-302. doi: 10.2165/11206690-000000000-00000.
Infanrix hexa, administered intramuscularly, is a diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine, indicated for primary and booster vaccination of infants. Infanrix hexa should be administered as a two- or three-dose primary vaccination course in infants aged < or =6 months, followed by booster vaccination between 11 and 18 months of age, with an interval of at least 6 months between the last dose of primary vaccination and the booster dose. This spotlight reviews the immunogenicity and protective effectiveness, as well as the reactogenicity and safety of Infanrix hexa. Infanrix hexa as primary and booster vaccination was safe and highly immunogenic for all its component toxoids/antigens in infants aged <2 years, regardless of vaccination schedules. Its immunogenicity and safety profiles were generally similar to those of currently available vaccines, the diphtheria, tetanus and acellular pertussis-based pentavalent vaccines plus monovalent HBV or Hib vaccines. In large clinical studies, Infanrix hexa elicited a strong immune response against vaccine toxoids/antigens, as indicated by high seroprotection/seropositivity/vaccine response rates and geometric mean titers. Moreover, antibodies against vaccine toxoids/antigens persisted for up to a mean of approximately 6 years after booster vaccination, and the vaccine induced long-term immune memory against hepatitis B surface antigen and Hib antigen. A strong immune response against Infanrix hexa toxoids/antigens after primary vaccination was also induced in infants who had received a dose of HBV vaccine at birth and in pre-term infants, although the response in the latter group was somewhat lower than that in full-term infants. In addition, when coadministered with other childhood vaccines, the immunogenicity of Infanrix hexa or that of the concomitantly administered vaccine was generally not altered. Hexavalent vaccines, including Infanrix hexa, were protective against invasive Hib disease; Infanrix hexa is also expected to be protective against pertussis. Most solicited local and general symptoms with Infanrix hexa were mild to moderate in intensity and the vaccine was associated with few unsolicited adverse events. Available clinical data from more than 10 years' experience with the vaccine suggest that Infanrix hexa as primary and booster vaccination is a safe and useful option for providing protection against the common childhood diseases of diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B and invasive Hib disease.
欣福立适（六联疫苗），肌内注射，用于预防白喉、破伤风、无细胞百日咳、乙型肝炎（HBV）、灭活脊髓灰质炎和流感嗜血杆菌 b 型（Hib），适用于婴儿的基础免疫和加强免疫。欣福立适（六联疫苗）应在 < 或 =6 月龄婴儿中进行 2-3 剂基础免疫接种，在 11-18 月龄时进行加强免疫接种，基础免疫最后一剂与加强免疫接种间隔至少 6 个月。本专题述评介绍了欣福立适（六联疫苗）的免疫原性和保护效力、不良反应和安全性。在 <2 岁的婴儿中，无论免疫程序如何，欣福立适（六联疫苗）作为基础免疫和加强免疫，其所有组分的类毒素/抗原均安全且高度具有免疫原性。其免疫原性和安全性概况与目前可获得的疫苗（基于白喉、破伤风和无细胞百日咳的五联疫苗，加单价 HBV 或 Hib 疫苗）相似。在大型临床研究中，欣福立适（六联疫苗）诱导了针对疫苗类毒素/抗原的强烈免疫应答，血清保护率/阳性率/疫苗应答率和几何平均滴度均较高。此外，加强免疫接种后，针对疫苗类毒素/抗原的抗体可持续长达平均约 6 年，并且疫苗诱导了针对乙型肝炎表面抗原和 Hib 抗原的长期免疫记忆。在接受过一剂 HBV 疫苗出生时接种和早产儿接种欣福立适（六联疫苗）的婴儿中，也诱导了针对欣福立适（六联疫苗）类毒素/抗原的强烈免疫应答，尽管后者组的反应略低于足月儿。此外，当与其他儿童疫苗同时给药时，欣福立适（六联疫苗）或同时给药的疫苗的免疫原性通常不会改变。六联疫苗，包括欣福立适（六联疫苗），可预防侵袭性 Hib 病；预计欣福立适（六联疫苗）也可预防百日咳。欣福立适（六联疫苗）最常见的局部和全身症状为轻至中度，疫苗接种后不良反应罕见。基于 10 多年的疫苗应用经验，目前已有足够的临床数据表明，欣福立适（六联疫苗）作为基础免疫和加强免疫接种，是预防白喉、破伤风、脊髓灰质炎、百日咳、乙型肝炎和侵袭性 Hib 病等常见儿童疾病的一种安全且有效的选择。
