未经评估:组合疫苗减少了儿科注射的次数,但必须是安全的,免疫原性,并且作为单独给予的每种疫苗有效。此外,制造批次的一致性对于世卫组织资格预审至关重要。本研究旨在建立完全液体的批次间一致性,六价白喉(D)-破伤风(T)-全细胞百日咳(wP)-灭活脊髓灰质炎病毒(IPV)-乙型肝炎(HB)-流感嗜血杆菌b(PRP-T)(DTwP-IPV-HB-PRP~T)疫苗,并证明其与许可的DTP-HB-PRP~T和IPV疫苗的非劣效性。
未经批准:第三阶段,随机化,主动控制,开放标签研究在印度的多个中心进行。接受口服脊髓灰质炎病毒疫苗和乙肝疫苗出生剂量的健康婴儿在6-8、10-12和14-16周龄时接受了三批DTwP-IPV-HB-PRP~T或单独的DTwP-HB-PRP~T和IPV疫苗之一。口服轮状病毒疫苗在6-8周龄和10-12/14-16周龄共同施用。使用血清保护率(抗D,反T,抗HBs,反PRP,抗脊髓灰质炎1、2、3)和调整后的几何平均浓度(抗PT,反FIM)。通过父母报告评估安全性。
UNASSIGNED:DTwP-IPV-HB-PRP~T证明了批次与批次之间的一致性,并且对于血清保护率差异和调整后的几何平均浓度比,在预定义的临床范围内,以95%CIs证实了DTwP-HB-PRP~T和IPV的非劣效性。抗D≥0.01IU/mL的集合血清保护率≥99.7%,抗T≥0.01IU/mL,抗-HBs≥10mIU/mL,抗PRP≥0.15µg/mL,抗脊髓灰质炎1、2和3≥8(1/dil),抗PT疫苗应答率为83.9%,抗FIM疫苗应答率为97.7%。没有安全问题。
UNASSIGNED:在6-8、10-12和14-16周龄接种后,三批完全液体的DTwP-IPV-HB-PRP~T疫苗的免疫原性是一致的,并且不劣于许可比较。没有安全性问题,也没有证据表明与轮状病毒疫苗共同施用有任何效果。
UNASSIGNED: Combination vaccines reduce the number of pediatric injections but must be as safe, immunogenic, and effective as each of the individual vaccines given separately. Additionally, consistency in manufacturing lots is essential for WHO prequalification. This study aimed to establish the lot-to-lot consistency of a fully liquid, hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) (DTwP-IPV-HB-PRP∼T) vaccine and to demonstrate non-inferiority to licensed DTwP-HB-PRP∼T and IPV vaccines.
UNASSIGNED: A Phase III, randomized, active-controlled, and open-label study was conducted at multiple centers across India. Healthy infants who had received a birth dose of oral poliovirus vaccine and hepatitis B vaccine received one of three lots of DTwP-IPV-HB-PRP∼T or separate DTwP-HB-PRP∼T and IPV vaccines at 6-8, 10-12, and 14-16 weeks of age. Oral rotavirus vaccine was co-administered at 6-8 weeks of age and 10-12/14-16 weeks of age. DTwP-IPV-HB-PRP∼T lot-to-lot consistency and non-inferiority (pooled DTwP-IPV-HB-PRP∼T) versus DTwP-HB-PRP∼T and IPV post-third dose were assessed using seroprotection rates (anti-D, anti-T, anti-HBs, anti-PRP, anti-polio 1, 2, 3) and adjusted geometric mean concentrations (anti-PT, anti-FIM). Safety was assessed by parental reports.
UNASSIGNED: Lot-to-lot consistency was demonstrated for DTwP-IPV-HB-PRP∼T and non-inferiority versus DTwP-HB-PRP∼T and IPV was confirmed with 95% CIs for seroprotection rate differences and adjusted geometric mean concentration ratios within pre-defined clinical margins. Pooled seroprotection rate was ≥ 99.7% for anti-D ≥ 0.01 IU/mL, anti-T ≥ 0.01 IU/mL, anti-HBs ≥ 10 mIU/mL, anti-PRP ≥ 0.15 µg/mL, and anti-polio 1, 2, and 3 ≥ 8 (1/dil) and vaccine response rate was 83.9% for anti-PT and 97.7% for anti-FIM. There were no safety concerns.
UNASSIGNED: Immunogenicity of three lots of the fully liquid DTwP-IPV-HB-PRP∼T vaccine was consistent and non-inferior to licensed comparators following vaccination at 6-8, 10-12, and 14-16 weeks of age. There were no safety concerns and no evidence of any effect of co-administration with rotavirus vaccine.