Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.)(Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.))

概要

基本信息

药物类型

联合疫苗、预防性疫苗、类毒素疫苗

别名

DTwP-Hib-IPV vaccine、DTwP-Hib-poliovirus vaccine、Easyfour Pol

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病呼吸系统疾病+ [1]

在研适应症-

非在研适应症

白喉嗜血杆菌感染脊髓灰质炎+ [2]

原研机构

Panacea Biotec Ltd.

在研机构-

非在研机构

Panacea Biotec Ltd.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.) 相关的临床试验

CTRI/2014/12/005326 / Completed临床3期

An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of DTwP-Hib vaccine (Easyfour-TT, Panacea Biotec Ltd.) with QuadrovaxÂ® (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd.) in Healthy Infants. - Easyfour-TT

开始日期2014-12-29

申办/合作机构

Panacea Biotec Ltd.

CTRI/2010/091/001261 / Completed临床1期

An Open Labeled, Noncomparative, Phase I Study to Evaluate the Safety and Tolerability of a Fully Liquid Pentavalent DTwP-Hib-IPV Vaccine (EasyfourpolTM) of Panacea Biotec Ltd. Administered in Healthy Children 15- 18 Months of age. - EasySix Phase I

开始日期2010-09-06

申办/合作机构

Panacea Biotec Ltd.

100 项与 Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.) 相关的临床结果

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100 项与 Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.) 相关的转化医学

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100 项与 Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.) 相关的专利（医药）

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23

项与 Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.) 相关的文献（医药）

2023-12-01·Pediatric Infectious Disease Journal

Antibody Persistence Following Administration of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T and IPV Vaccines and Safety and Immunogenicity of a Booster Dose of DTwP-IPV-HB-PRP~T Administered With an MMR Vaccine in Healthy Infants in India

Article

作者: Palvi, Kudyar ; Kandukuri, Sreeramulu Reddy ; Mitra, Monjori ; Palkar, Sonali ; Mangarule, Somnath ; Leclercq, Julie ; Siddaiah, Prashanth ; Noriega, Fernando ; Singh, Raghvendra ; Shetty, Ranjitha ; Varghese, Kucku ; Kukian, Darshna ; Padmavathi, Inumarthi Vara ; Midde, Venkata Jayanth ; Tripathi, Virendranath ; Kawade, Anand ; Dhati, Ravi Mandyam

Background:Antibody persistence of a whole-cell pertussis-containing hexavalent vaccine (DTwP-IPV-HB-PRP~T) and its co- or sequential administration with measles, mumps, rubella (MMR) vaccine were evaluated.Methods:Phase III, open-label, randomized, multicenter study in India. Healthy toddlers 12–24 months of age who had received DTwP-IPV-HB-PRP~T or separate DTwP-HB-PRP~T+IPV primary vaccination at 6–8, 10–12 and 14–16 weeks of age received a DTwP-IPV-HB-PRP~T booster concomitantly with MMR (N = 336) or 28 days before MMR (N = 340). Participants had received a first dose of measles vaccine. Immunogenicity assessment used validated assays and safety was by parental reports. All analyses were descriptive.Results:All participants had prebooster anti-T ≥0.01 IU/mL and anti-polio 1 and 3 ≥8 1/dil, and ≥96.5% had anti-D ≥0.01 IU/mL, anti-HBs ≥10 mIU/mL, anti-polio 2 ≥8 1/dil and anti-PRP ≥0.15 µg/mL; for pertussis, antibody persistence was similar in each group. Postbooster immunogenicity for DTwP-IPV-HB-PRP~T was similar for each antigen in each group: ≥99.5% of participants had anti-D ≥0.01 IU/mL, anti-T ≥0.01 IU/mL, anti-polio 1, 2 and 3 >8 1/dil, anti-HBs ≥10 mIU/mL and anti-PRP ≥1 µg/mL; for pertussis, vaccine response was similar in each group [72.0%–75.9% (anti-PT), 80.8%–81.4% (anti-FIM), 77.6%–79.5% (anti-PRN), 78.2%–80.8% (anti-FHA)]. There was no difference in MMR immunogenicity between groups, and no difference in DTwP-IPV-HB-PRP~T booster immunogenicity based on the primary series. There were no safety concerns.Conclusions:DTwP-IPV-HB-PRP~T antibody persistence was similar to licensed comparators. Booster immunogenicity was robust after DTwP-IPV-HB-PRP~T with or without MMR, and MMR immunogenicity was not affected by coadministration with DTwP-IPV-HB-PRP~T.Clinical Trials Registry India Number:CTRI/2020/04/024843.

2023-08-01·Pediatric Infectious Disease Journal

Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand

Article

作者: Sanchez, Leilani ; Jantarabenjakul, Watsamon ; Midde, Venkata Jayanth ; Mangarule, Somnath ; Yaiprayoon, Yuvadee ; Leclercq, Julie ; Varghese, Kucku ; Noriega, Fernando ; Kosalaraksa, Pope ; Rungmaitree, Supattra

Background:This study investigated the immunogenicity and safety of a fully liquid, hexavalent, diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) vaccine compared to licensed DTwP-HB-PRP~T, IPV, and bivalent oral poliovirus (bOPV) vaccines following co-administration with other pediatric vaccines [pneumococcal conjugate vaccine (PCV13) and rotavirus vaccine].Methods:Phase III, randomized, open-label study in Thailand. Healthy infants received DTwP-IPV-HB-PRP~T at 2, 4 and 6 months of age (N = 228), or DTwP-HB-PRP~T and bOPV (2, 4 and 6 months of age) and IPV (4 months of age) (N = 231). All participants received PCV13 (2, 4 and 6 months of age) and rotavirus vaccine (2 and 4 months of age). Immunogenicity for all antigens was assessed using validated assays, and noninferiority post-third dose was evaluated for anti-D, anti-T, anti-pertussis [anti-pertussis toxin (anti-PT) and anti-fimbriae 2/3 (anti-FIM)], anti-polio 1, 2, 3, anti-HB, and anti-PRP~T. Safety was assessed using parental reports.Results:Noninferiority was demonstrated for each antigen, and overall noninferiority of DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV was concluded. Similarity in each group was observed for the GMC ratio for antirotavirus antibodies (20.9 and 17.3, respectively) and anti-PCV13 antibodies (range: 8.46–32.6 and 7.53–33.1, respectively). Two serious adverse events were related to DTwP-IPV-HB-PRP~T (febrile convulsion and acute febrile illness) and 1 was related to DTwP-HB-PRP~T+bOPV+IPV (febrile seizure), but overall there were no safety concerns with similar rates of participants experiencing solicited (99.1% and 98.3%) and unsolicited (19.3% and 19.5%) adverse events in each group.Conclusions:This study confirmed the suitability of DTwP-IPV-HB-PRP~T primary series vaccination in combination with rotavirus and PCV13 vaccines.

2023-01-02·Human Vaccines & Immunotherapeutics

Reduced reactogenicity of primary vaccination with DT3aP-HBV-IPV/Hib compared with DT2aP-HBV-IPV-Hib among infants: Mathematical projections in six countries

Article

作者: Berlaimont, Valerie ; AbdelGhany, Mohammad ; Ruiz Garcia, Yara ; Turriani, Elisa ; George, Marina ; Kosse, Richelle C. ; Gkalapi, Foteini ; Perez Martin, Jaime ; Jamet, Nicolas

The hexavalent vaccines DT3aP-HBV-IPV/Hib and DT2aP-HBV-IPV-Hib are routinely used for primary immunization of infants against diphtheria, tetanus, pertussis, hepatitis B virus, poliomyelitis, and Haemophilus influenzae type b. A recent publication showed that after primary immunization with these vaccines, the odds ratios of adverse reactions (ARs) were significantly lower for DT3aP-HBV-IPV/Hib than for DT2aP-HBV-IPV-Hib. Our aim is to understand the impact of the various reactogenicity profiles at country level by comparing the ARs induced by one dose of DT3aP-HBV-IPV/Hib versus DT2aP-HBV-IPV-Hib in the primary infant immunization course. A mathematical projection tool was developed to simulate vaccination of infants with both vaccines in six countries: Austria, the Czech Republic, France, Jordan, Spain, and the Netherlands. Proportions of three local and five systemic ARs of interest for both vaccines were based on findings from a previous meta-analysis of ARs in infants. The absolute risk reductions calculated ranged from 3.0% (95% confidence interval [CI]: 2.8%-3.2%) for "Swelling at the injection site, any grade" to 10.0% (95% CI: 9.5%-10.5%) for "Fever, any grade." The difference in occurrence of the AR "Fever, any grade" between vaccines in 2020 ranged from over 7,000 in Austria to over 62,000 in France. Over 5 years, this would amount to a reduction of over 150,000 ARs in Austria and over 1.4 million ARs in France when using DT3aP-HBV-IPV/Hib instead of DT2aP-HBV-IPV-Hib. In conclusion, the estimated numbers of ARs following hexavalent vaccination in six countries showed that vaccination of infants with DT3aP-HBV-IPV/Hib could lead to fewer ARs than vaccination with DT2aP-HBV-IPV-Hib.

100 项与 Hib-DTP-poliovirus vaccine(Panacea Biotec Ltd.) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
白喉	临床3期	印度	Panacea Biotec Ltd.	-
嗜血杆菌感染	临床3期	印度	Panacea Biotec Ltd.	-
脊髓灰质炎	临床3期	印度	Panacea Biotec Ltd.	-
破伤风	临床3期	印度	Panacea Biotec Ltd.	-
百日咳	临床3期	印度	Panacea Biotec Ltd.	-