更新于：2024-11-02
Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.)
更新于：2024-11-02
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1
项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的临床试验A Phase-III multicentric randomized open label, active Controlled study to evaluate the Immunogenicity and Safety of BBILs combination of DTwPHib (Comvac4) vaccine in comparison with Reference Vaccine Comvac3â?¢ BioHib in healthy infants of 6 to 7 weeks age - Comvac4
100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的临床结果
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100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的转化医学
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100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的专利（医药）
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15
项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的文献（医药）2018-04-01Vaccine3区 · 医学
A randomized, open label trial to evaluate and compare the immunogenicity and safety of a novel liquid hexavalent DTwP-Hib/Hep B-IPV (EasySix™) to licensed combination vaccines in healthy infants
3区 · 医学
Article
作者: Panwar, Sachin ; Mohanty, Lalitendu ; Paliwal, Charu ; Gupta, Anu ; Chilkoti, Deepak Chandra ; Behera, Beauty ; Sharma, Sunil ; Singh, Anit
CLINICAL TRIAL REGISTRATION:
CTRI/2015/02/005578.
2015-09-01Biologicals : journal of the International Association of Biological Standardization4区 · 生物学
Patterns of binding of aluminum-containing adjuvants to Haemophilus influenzae type b and meningococcal group C conjugate vaccines and components
4区 · 生物学
Article
作者: Otto, Robert B D ; Crane, Dennis T ; Burkin, Karena ; Bolgiano, Barbara ; Amir, Saba Erum
The basis of Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroup C (MenC) glycoconjugates binding to aluminum-containing adjuvants was studied. By measuring the amount of polysaccharide and protein in the non-adsorbed supernatant, the adjuvant, aluminum phosphate, AlPO4, was found to be less efficient than aluminum hydroxide, Al(OH)3 at binding to the conjugates, at concentrations relevant to licensed vaccine formulations and when equimolar. At neutral pH, binding of TT conjugates to AlPO4 was facilitated through the carrier protein, with only weak binding of AlPO4 to CRM197 being observed. There was slightly higher binding of either adjuvant to tetanus toxoid conjugates, than to CRM197 conjugates. This was verified in AlPO4 formulations containing DTwP-Hib, where the adsorption of TT-conjugated Hib was higher than CRM197-conjugated Hib. At neutral pH, the anionic Hib and MenC polysaccharides did not appreciably bind to AlPO4, but did bind to Al(OH)3, due to electrostatic interactions. Phosphate ions reduced the binding of the conjugates to the adjuvants. These patterns of adjuvant adsorption can form the basis for future formulation studies with individual and combination vaccines containing saccharide-protein conjugates.
2013-08-01The Pediatric infectious disease journal4区 · 医学
Antibody Persistence and Booster Vaccination of a Fully Liquid Hexavalent Vaccine Coadministered With Measles/Mumps/Rubella and Varicella Vaccines at 15–18 Months of Age in Healthy South African Infants
4区 · 医学
Article
作者: Koen, Anthonet ; Cutland, Clare ; Groome, Michelle ; Santos-Lima, Eduardo ; Madhi, Shabir A
OBJECTIVE:
To assess antibody persistence and booster immunogenicity and safety of a new, fully liquid, hexavalent DTaP-IPV-Hep B-PRP-T vaccine.
METHODS:
Phase III, open-label, 2-center trial. Infants previously primed at 6, 10, 14 weeks of age with DTaP-IPV-Hep B-PRP-T either without (group 1: N = 218) or with hepatitis B at birth (group 3: N = 130) or control DTwP-Hib, hepatitis B and oral poliovirus vaccine vaccines (group 2: N = 219) received the same vaccine(s) as booster (except hepatitis B for group 2) at 15-18 months of age, coadministered with measles/mumps/rubella and varicella vaccines (MMR+V). All participants had received measles vaccine at 9 months of age. Antibodies were measured prebooster and 1 month postbooster vaccination. Safety was evaluated from parental reports. Analyses were descriptive.
RESULTS:
Antibody persistence (seroprotection and concentration) at 15-18 months of age was high for each valence and similar in each group, except for Hep B (highest in group 3 [extra dose of hepatitis B]) and PRP (highest in group 2). Postbooster seroprotection (D, T, IPV, Hep B, PRP) and seroconversion (pertussis toxin and filamentous hemagglutinin) rates were high and similar in each group (excluding Hep B in group 2 [no booster]); geometric mean antibody levels increased markedly in all groups. The response to MMR+V was similar in each group. All vaccines were well tolerated.
CONCLUSIONS:
A booster dose of the new DTaP-IPV-Hep B-PRP-T vaccine at 15-18 months of age is highly immunogenic and safe compared with licensed comparators, following primary series administration in the Expanded Program on Immunization schedule, with or without a hepatitis B vaccine at birth and coadministered with MMR+V.
1
项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的新闻（医药）2024-01-30
100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
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| 白喉 | 印度 | 2016-02-19 | |
| 乙型肝炎 | 印度 | 2016-02-19 | |
| 破伤风 | 印度 | 2016-02-19 | |
| 百日咳 | 印度 | 2016-02-19 |
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