吸附无细胞百白破、灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗(DTaP．IPV／Hib联疫苗)应用技术指南

百日咳、白喉、破伤风、脊髓灰质炎(脊灰)、b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)引起的感染性疾病是常见的严重危害人类健康,特别是儿童健康的传染病.预防接种是控制这五种疾病最经济、有效的措施,通常预防儿童这五种疾病需要分别接种吸附百白破联合疫苗(DPT)、口服脊灰减毒活疫苗(OPV)和Hib疫苗,幼儿完成全程免疫累计需要接种11剂次[1,2].儿童接种疫苗剂次的增加,不但增加服务的成本,且还会增加疑似预防接种异常反应的风险.国家食品药品监督管理局已于2010年批准吸附无细胞百白破(DTaP)、灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗(DTaP-IPV/Hib五联疫苗,简称五联疫苗)在中国上市.接种五联疫苗预防上述五种疾病,幼儿完成全程免疫累计仅需接种4剂次[3].     

1例预防接种偶合血小板减少性紫癜的调查

2015年5月26日,无锡市北塘区疾控中心接到黄巷预防接种门诊报告,1名婴儿在接种吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗后出现血小板减少性紫癜。经流行病学调查,结合实验室检测,北塘区预防接种异常反应调查诊断专家组诊断该例预防接种反应与病毒感染有关,属于接种偶合症。     

1例预防接种事故引起纠纷的司法鉴定思考

本文报道1例同时接种b型流感嗜血杆菌结合疫苗(Hib疫苗)、吸附无细胞百日咳、白喉、破伤风联合疫苗(简称无细胞百白破疫苗)、口服脊髓灰质炎减毒疫苗糖丸(脊灰减毒活疫苗)后致残引起医患纠纷的案例,经2次近13个月的预防接种异常反应调查诊断结论无果,建议医患双方行司法路径解决争议。本文就本例预防接种引起的纠纷涉及司法鉴定谈谈个人观点和体会。     

无锡市北塘区0～2岁儿童第二类疫苗接种现况调查分析

目的了解无锡市北塘区0~2岁儿童第二类疫苗的接种特征,为科学管理第二类疫苗提供依据。方法选取北塘区8 119名0~2岁儿童为研究对象,分析其第二类疫苗接种情况。结果灭活脊髓灰质炎疫苗、吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗、水痘减毒活疫苗、b型流感嗜血杆菌结合疫苗、23价肺炎球菌多糖疫苗、流感疫苗、口服轮状病毒减毒活疫苗的接种率分别为7.24%、5.36%、22.65%、18.92%、0.47%、2.30%、3.81%,平均接种率为8.68%,差异有统计学意义;不同地区、不同年龄组之间疫苗接种率差异均有统计学意义;多剂次免疫程序的第二类疫苗全程接种率较低。结论第二类疫苗的接种率较低,需要进一步采取措施提高接种率,以建立有效的免疫屏障。     

接种吸附无细胞百白破-灭活脊髓灰质炎-b型流感嗜血杆菌联合疫苗后偶合特发性血小板减少性紫癜1例报告

<正>2013年4月浙江省德清县某预防接种门诊报告1例接种吸附无细胞百白破-灭活脊髓灰质炎-b型流感嗜血杆菌联合疫苗(Absorbed DiphtheriaTetanus-Acellular Pertussis-Inactivated PoliomyelitisHaemophilus Influenzae Type b Combined Vaccine,DTa P-IPV-Hib)后出现特发性血小板减少性紫癜(Idiopathic Thrombocytopenic Purpura,ITP)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)病例,经当地预防接种异常反应调查诊断专家组诊断,确定该病例与接种疫苗无因果关联,     

1例联合疫苗接种后偶合特发性血小板减少性紫癜病例调查与思考

正预防接种是预防相应传染病经济有效的手段,然而随着疫苗接种的普及和疫苗接种种类增多,疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)发生也相应增加,如果对发生的AEFI处理不当,将会伤及疫苗预防接种诸多方面[1]。本文介绍了1名儿童接种吸附无细胞百白破-灭活脊髓灰质炎-b型流感嗜血杆菌联合疫苗     

候选无细胞百白破-Sabin株灭活脊髓灰质炎联合疫苗免疫小鼠的效果研究

目的观察候选无细胞百白破-Sabin株灭活脊髓灰质炎联合疫苗(DTaP-sIPV)在小鼠中的免疫原性,为疫苗临床前研究提供依据。方法将候选疫苗分别稀释成5倍、10倍、20倍三组,以相应稀释的无细胞百白破-灭活脊髓灰质炎-b型流感嗜血杆菌联合疫苗(DTaP-IPV/Hib)、无细胞百白破联合疫苗(DTaP)为对照组,每组按0、4、8周3剂免疫程序免疫NIH小鼠(10只/组),检测各组小鼠每剂免疫后28d的血清百白破组分抗体水平。结果候选疫苗三个组完成3剂次免疫后PT抗体的几何平均浓度(GMC)(IU/mL)分别为2 157.29、2 142.51、2 135.17;FHA抗体GMC分别为10 098.30、10 068.33、9 143.30;PRN抗体GMC分别为1 683.86、1 130.29、193.00;DT抗体几何平均滴度(GMT)(1∶)分别为23.48、22.44、22.44;TT抗体GMT分别为22.31、21.24、21.34。候选疫苗三个组PT、FHA、DT、TT抗体水平均高于两种疫苗对照组或者与其无显著性差异,但PRN抗体水平低于DTaP对照组。结论候选疫苗免疫小鼠具有良好的免疫原性。     

北京市DTaP-IPV/Hib五联疫苗接种率调查及影响因素分析

目的 了解北京市0～3岁儿童DTaP-IPV/Hib五联疫苗,即吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗接种率及影响因素,为制定免疫策略提供建议.方法 采用与人口规模大小成比例的概率抽样及简单随机抽样相结合的方法抽取北京市480名儿童监护人为调查对象,填写《儿童监护人预防接种知识、态度和行为的问...     

联合疫苗的4个关键问题

<正>我们以前提到过联合疫苗是疫苗发展的必然趋势。联合疫苗,是指将两种或两种以上不同病原的抗原,按特定比例混合制成的可以预防多种疾病的疫苗。联合疫苗的概念始于上世纪30年代,如今全球已有100多个国家使用联合疫苗了。Q目前我国常用的联合疫苗有哪些?A国内常用的含两种以上不同病原抗原的联合疫苗有3种。包括百白破联合疫苗、麻腮风联合减毒活疫苗、灭活脊髓灰质炎百白破b型流感嗜血杆菌联合疫苗,     

2017-2019年天津市某区含无细胞百白破联合疫苗预防接种安全性评价

目的 评价天津市滨海新区含无细胞百日咳、白喉和破伤风联合疫苗(DTaP)成分的联合疫苗预防接种安全性.方法 通过中国免疫规划信息管理系统AEFI信息管理系统收集2017-2019年天津市滨海新区报告的DTaP、DTaP-b型流感嗜血杆菌联合疫苗(DTaP-Hib)和DTaP-灭活脊髓灰质炎-Hib联合疫苗(DTaP-I...     

Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China

The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim^®) compared to individual vaccines in infants in the People's Republic of China. Infants (N = 792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib^®) and IPV (Imovax^® Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.     

Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, and haemophilus B conjugate vaccine and guidance for use in infants and children

On June 20, 2008 the Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus vaccine (IPV), and Haemophilus influenzae type b conjugate (tetanus toxoid [TT] conjugate) vaccine, DTaP-IPV/Hib (Pentacel, Sanofi Pasteur, Swiftwater, Pennsylvania), for use as a four-dose series in infants and children at ages 2, 4, 6, and 15-18 months. This report summarizes the indications for Pentacel and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.     

Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea

This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim™) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately. Immunogenicity was high in both groups; seroprotection and seroconversion rates of the combined vaccine (Group A) were non-inferior to the control vaccines (Group B). All subjects were seroprotected against poliovirus types 1, 2 and 3 (≥8 1/dil) and anti-diphtheria (≥0.01 IU/mL); 99.0% were seroprotected against tetanus (≥0.1 IU/mL). At least 93.6% had anti-diphtheria antibody titers ≥0.1 IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (≥4-fold increase in antibody titer) rates were 96.6% and 94.4% for Group A, 92.2% and 78.4% for Group B. Most solicited reactions occurred within 4 days of vaccination, resolved within 3 days and were mild. Severe solicited reactions occurred after ≤0.5% of doses in Group A and ≤0.9% in Group B. No withdrawals occurred because of adverse events. The DTaP-IPV combined vaccine given at 2, 4, and 6 months of age was well tolerated; immunogenicity was similar to the control vaccines.     

Immunogenicity and reactogenicity of diphtheria, tetanus and pertussis toxoids combined with inactivated polio vaccine, when administered concomitantly with or as a diluent for a Hib conjugate vaccine

In an open trial, 400 infants were randomized to vaccination with a combined diphtheria-tetanus-pertussis-inactivated polio vaccine (DTaP-IPV) either mixed with a Haemophilus influenzae type b (Hib) tetanus toxoid conjugate immediately before injection (DTaP-IPV/Hib (mix)) or given concurrently with the Hib conjugate at separate injection sites (DTaP-IPV+Hib (sep)). The pertussis component consisted of pertussis toxoid alone. The vaccines were given intramuscularly at 3, 5 and 12 months of age. No vaccine-related serious adverse events occurred. Local reactions were evaluated from diary cards completed by the parents. Infants who received DTaP-IPV/Hib (mix) experienced fewer local reactions. Sera were obtained 28-45 days after the second and third vaccinations. Total Hib capsular antibodies were similar in the two groups after the second injection but lower in the group receiving DTaP-IPV/Hib (mix) than in the group receiving DTaP-IPV+Hib (sep) after the third injection (geometric mean 6.1 vs 10.4 microg/ml). Mixing of the vaccines also led to somewhat lower diphtheria toxin antibodies (5.9 vs. 7.7 IU/ml after the third injection) while tetanus antibodies were higher (3.9 vs. 2.5 IU/ml after the third injection). Antibodies against pertussis toxin and the three polio virus types were similar in the two groups. The moderate impairment of the Hib antibody response caused by mixing of the Hib conjugate with aluminium adsorbed DTaP may be due to physicochemical interference but is probably of little clinical importance because of the ability of the Hib conjugates to induce an immunologic memory.     

Associated or combined vaccination of Brazilian infants with a conjugate Haemophilus influenzae type b (Hib) vaccine, a diphtheria-tetanus-whole-cell pertussis vaccine and IPV or OPV elicits protective levels of antibodies against Hib

This study investigated the immunogenicity and safety of including a Haemophilus influenzae type b vaccine (polyribosylribitol phosphate conjugated to tetanus toxoid, PRP-T) in three different vaccination schemes: (1) PRP-T reconstituted with a combined diphtheria-tetanus-pertussis-inactivated poliovirus vaccine (DTP-IPV//PRP-T); (2) PRP-T reconstituted with DTP and administered concomitantly with an oral poliovirus vaccine (DTP//PRP-T+OPV); and (3) PRP-T administered concomitantly with DTP at a different injection site and OPV (DTP+PRP-T+OPV). Vaccines were given at 2, 4, and 6 months of age. A total of 252 infants were enrolled, and randomly assigned to one of the three vaccination groups (84 infants in each group); 241 infants were followed until the end of the study. Antibody production against PRP, diphtheria, tetanus and pertussis antigens was satisfactory for each vaccination scheme used. A good response to Hib vaccine was elicited in each group, and 3 months after the third vaccine dose, at least 97% of children in each group had levels of PRP antibody considered to be seroprotective (>0.15 microg/ml), and over 90% of children in each group had levels over 1. 0 microg/ml. The solicited local and systemic adverse events following vaccination were mild in all groups and resolved within 4 days without medical intervention. With the exception of fever, which was more common after the second dose in children who received DTP-IPV//PRP-T, local and systemic reactions did not differ between the vaccination groups. Due to the practical advantages of combined vaccines, their use in routine immunization programs in developing countries is highly desirable. Our results show that Hib conjugate vaccine can be included in routine immunization programs that include either OPV or IPV with satisfactory immunogenicity and safety profiles. This flexible approach should facilitate the inclusion of the Hib conjugate vaccine in routine immunization programs on a world-wide scale.     

Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III,randomized, observer-blind,multicenter, parallel-group study

BackgroundBroad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged <1 year. In Japan, PRP conjugated to tetanus toxoid (PRP-T) vaccine has been widely used since the initiation of public funding programs followed by a routine vaccination designation in 2013.MethodsWe compared the immunogenicity and safety of PRP conjugated to a non-toxic diphtheria toxin mutant (PRP-CRM₁₉₇) vaccine with the PRP-T vaccine when administered subcutaneously to healthy Japanese children in a phase III study. Additionally, we evaluated the immunogenicity and safety profiles of a diphtheria–tetanus acellular pertussis (DTaP) combination vaccine when concomitantly administered with either PRP-CRM₁₉₇ or PRP-T vaccines. The primary endpoint was the “long-term seroprotection rate”, defined as the group proportion with anti-PRP antibody titers ⩾1.0 μg/mL, after the primary series.ResultsLong-term seroprotection rates were 99.3% in the PRP-CRM₁₉₇ group and 95.6% in the PRP-T group. The intergroup difference (PRP-CRM₁₉₇ group – PRP-T group) was 3.7% (95% confidence interval: 0.099–7.336), demonstrating that PRP-CRM₁₉₇ vaccine was non-inferior to PRP-T vaccine (p < 0.0001). Furthermore, the “short-term seroprotection rate” (anti-PRP antibody titer ⩾0.15 μg/mL) before booster vaccination was higher in the PRP-CRM₁₉₇ group than in PRP-T. Concomitant administration of PRP-CRM₁₉₇ vaccine with DTaP vaccine showed no differences in terms of immunogenicity compared with concomitant vaccination with PRP-T vaccine and DTaP vaccine. Although CRM₁₉₇ vaccine had higher local reactogenicity, overall, both Hib vaccines had acceptable safety and tolerability profiles.ConclusionThe immunogenicity of PRP-CRM₁₉₇ vaccine administered subcutaneously as a three-dose primary series in children followed by a booster vaccination 1 year after the primary series induced protective levels of Hib antibodies with no safety or tolerability concerns.Clinical trial registry: Registered on ClinicalTrials.gov: NCT01379846     

The effect of reconstitution of an Haemophilus influenzae type b-tentanus toxoid conjugate (PRP-T) vaccine on the immune responses to a diphtheria-tetanus-whole cell pertussis (DTwP) vaccine: a five-year follow-up.

Controversial results have been obtained from previous studies on the combined administration of Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-whole-cell pertussis (DTwP) combination vaccines, with regard to possible reciprocal interference between the constituent antigens. To document the priming effect and possible long-term immunogenic interference of PRP-T and DTwP combination vaccines, a randomized, double-blind, controlled study was conducted in Belgium. A total of 168 healthy infants received, at 3, 4 and 5 months of age, DTwP vaccine mixed just prior to injection either with PRP-T vaccine (group A, DTwP//PRP-T, N = 85) or with placebo (group B, DTwP//Placebo, N = 83). At the age of 14 months, children of both groups were randomized to receive either a dose of DTwP//PRP-T vaccine (subgroups A1 and B1) or a dose of Hib polysaccharide (PRP) vaccine (subgroups A2 and B2). Those children in subgroups A1 and B1 had an additional serum sample taken at the age of 5 years (at the time of a DT booster). The immune response to Hib polysaccharide at the age of 4, 5 and 6 months confirmed the excellent immunogenicity profile of PRP-T in infants. In addition, the vigorous anamnestic response (i.e. a 20-fold increase of GMT) to a booster dose of the plain capsular polysaccharide (PRP) reflected the efficient Hib-priming induced by the combined DTwP//PRP-T vaccine. Reconstitution of PRP-T with DTwP did not affect the immune response to diphtheria toxoid or pertussis agglutinins. Nevertheless, at almost any time point during the five-year follow-up, the tetanus antitoxin GMT values were significantly lower in the DTwP//PRP-T group (A and A1) than in the DTwP//Placebo group (B and B1). Despite the suppressive effect on GMT values, intergroup differences in rates of seroprotection were never significant, except after doses 2 and 3 for which there were lower percentages of children in group A with antitoxin titers > 0.05 IU/mL and > 1.0 IU/mL. In the group primed with the combined DTwP//PRP-T vaccine, (1) a DT booster dose at the age of 5 years provoked a 150-fold increase in tetanus antitoxin GMT, (2) a high tetanus antitoxin GMT value was attained (GMT = 19.3 IU/mL) and (3) all children in this group had tetanus antitoxin titers > 1.0 IU/mL, so it may be concluded that all these children will still be protected against tetanus until at least the age of the next recommended booster dose (i.e. the age of 15 years). No differences in the occurrence of adverse events were observed between the groups who received the DTwP//PRP-T vaccine or the DTwP//Placebo vaccine, both vaccines being associated with events customarily attributable to DTwP (data not shown). Our results indicate (1) that the combination vaccine, DTwP//PRP-T, represents a safe and effective alternative for the existing uncombined vaccines and (2) that the long-term effect of interference between the components of future combination vaccines should be studied with subsequent booster doses, followed by the evaluation of persistence of antibodies over several years.     

Priming effect, immunogenicity and safety of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-acellular pertussis (DTaP) combination vaccine administered to infants in Belgium and Turkey

To evaluate the priming effect, immunogenicity and safety of an Haemophilus influenzae type b (Hib) tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-acellular (two component) pertussis (DTaP) combination vaccine, a randomized, comparative study was conducted in two centers, one in Belgium and one in Turkey. A total of 410 healthy infants, 160 in Belgium and 250 in Turkey, randomly received DTaP and PRP-T vaccines in one of three fashions. One group (N = 138) received DTaP and PRP-T vaccines reconstituted immediately prior to injection at 3, 4 and 5 months of age, and are referred to as the combined, short schedule group (Co-S). A second group (N = 135) received DTaP + PRP-T simultaneously but injected at different sites according to the same schedule, and are referred to as the associated, short schedule group (As-S). The third group (N = 137) also received DTaP + PRP-T at separate sites, but at 2, 4 and 6 months, and are referred to as the associated, long schedule group (As-L). The As-L group allowed for serological bridging with a Senegalese two-component pertussis vaccine efficacy trial, using the same batch of DTaP vaccine. Children of both short-schedule groups (Co-S and As-S) received, at the age of 12-14 months, a booster dose of DTaP vaccine associated with unconjugated PRP vaccine. Mixing of the vaccines did not affect the immune response to the antigens included in the DTaP vaccine. The immune response to Hib capsular polysaccharide, however, was significantly lower after combined administration (Co-S group) than after associated (As-S group) administration (P < 0.0001), with a similar trend among both countries (GMTs, 1.78 microg/ml and 6.19 microg/ml in Belgium, and 5.02 microg/ml and 11.67 microg/ml in Turkey). Booster vaccination with the unconjugated PRP induced a vigorous and similar anamnestic response in both groups. Belgian infants showed a significantly lower immune response to all antigens than Turkish infants (P < or = 0.001 for all antigens), with a similar trend among each study group. In all groups, the incidence of adverse events was lower than that usually reported after DTwP(whole-cell) vaccine. Higher rates of systemic reactions were observed in the Belgian population, possibly due to differences in reporting practice. Our results indicate (1) that the combination vaccine, DTaP//PRP-T, represents an important improvement over the existing uncombined vaccines; (2) that immunogenicity studies should include at least one booster injection to evaluate priming effects by combined vaccines; and (3) that it is feasible and valuable to co-randomize combination vaccine studies in sufficiently different geographical areas and child populations.     

Extensive swelling of the limb and systemic symptoms after a fourth dose of acellular pertussis containing vaccines in England in children aged 3–6 years

Extensive limb swelling (ESL) after a booster dose of acellular pertussis (aP) containing vaccine can cause concern and has the potential to be confused with cellulitis. In the United Kingdom aP-containing vaccine was introduced for primary immunisation at 2, 3 and 4 months of age in 2004, with the first cohorts eligible to receive a fourth dose in 2007 at school entry. We assessed the frequency of ESL (here defined as swelling >100 mms diameter) in 973 children receiving a fourth dose of one of four aP vaccines given combined with inactivated polio, tetanus and either low dose diphtheria (TdaP/IPV) or high dose diphtheria (DTaP/IPV) vaccine; 2 of the 3 DTaP/IPV vaccines also contained Haemophilus influenza b conjugate vaccine (Hib). Post-vaccination symptoms and local reactions were recorded in 7-day diaries or by a telephone follow up if no diary was returned. Local swellings >50 mm diameter were reported by 2.2% TdaP/IPV recipients compared with 6.6–11.1% of DTaP/IPV recipients; the corresponding proportions for redness >50 mms was 7.0% for TdaP/IPV and 13.3–17.7% for DTaP/IPV recipients. Among the latter, the addition of Hib did not affect the frequency or size of local reactions. Pain at the injection site and systemic symptoms did not differ between the four vaccine groups. A history of atopy was not associated with development of local swelling or redness. A total of 13 children (1.3%) experienced an ESL, three after TdaP/IPV. ESLs resolved without systemic upset within a few days and were usually painless; medical advice was only sought for two children. Parents should be informed about the possible occurrence of an ESL with the pre-school aP-containing booster vaccine but can be reassured that it is a benign and transient condition.     

Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine and guidance for use as a booster dose

On June 24, 2008, the Food and Drug Administration licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine, DTaP-IPV (Kinrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Kinrix is licensed for use as the fifth dose of the DTaP vaccine series and the fourth dose of the IPV series in children aged 4-6 years whose previous DTaP vaccine doses were DTaP (Infanrix, GlaxoSmithKline) and/or DTaP-Hepatitis B-IPV (Pediarix, GlaxoSmithKline) for the first 3 doses and DTaP (Infanrix) for the fourth dose. DTaP-IPV administered to children aged 4-6 years would reduce by one the number of injections needed to complete DTaP and IPV immunization. This report summarizes the indications for Kinrix and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.