A Randomized, Comparative, Open Labeled, Multicentric, Phase I Study To Evaluate And Compare The Safety, Tolerability And Immunogenicity Of Two Formulations (With And Without Preservative) Of 10-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NucovacÂ® Of Panacea Biotec Ltd. With SynflorixÂ® Of Glaxosmithkline Ltd. In Healthy Infants - Nucovac Infant

开始日期2014-04-19

申办/合作机构

Panacea Biotec Ltd.

CTRI/2013/05/003711

/ Active, not recruiting临床1/2期

A Randomized, Open Label, Comparative, Single Dose Phase I/II Study to Evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVACÂ® in Healthy Adults - NUCOVAC

开始日期2013-06-04

申办/合作机构

Panacea Biotec Ltd.

100 项与 Pneumococcal vaccine conjugate 10-valent(Panacea Biotec Ltd.) 相关的临床结果

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100 项与 Pneumococcal vaccine conjugate 10-valent(Panacea Biotec Ltd.) 相关的转化医学

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项与 Pneumococcal vaccine conjugate 10-valent(Panacea Biotec Ltd.) 相关的文献（医药）

2021-06-01·The Lancet Infectious Diseases1区 · 医学

Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial

1区 · 医学

Article

作者: Saidy-Jah, Ebrima ; Umesi, Ama ; Ochoge, Magnus ; Innis, Bruce L ; Adigweme, Ikechukwu ; Badjie Hydara, Mariama ; Clarke, Ed ; Alderson, Mark R ; Obayemi, Dolapo ; Andi-Lolo, Indah ; Antony, Kalpana ; Futa, Ahmed ; Onwuchekwa, Chukwuemeka ; Dhere, Rajeev ; Hosken, Nancy ; Edem, Bassey ; Taylor, Douglas ; Goldblatt, David ; Sethna, Vistasp ; Kampmann, Beate ; Bashorun, Adedapo ; Lamola, Steve

BACKGROUNDAn affordable pneumococcal conjugate vaccine (PCV) is needed to ensure sustainable access in low-income and middle-income countries. This trial examined the immunogenicity and safety of a novel ten-valent PCV (SIIPL-PCV) containing serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F compared with the pneumococcal polysaccharide protein D-conjugate vaccine (PHiD-CV; Synflorix; GlaxoSmithKline; Brentford, UK).METHODSIn this single-centre, randomised, double-blind, phase 3, non-inferiority trial in The Gambia, healthy, PCV-naive infants aged 6-8 weeks were enrolled and assigned using permuted block randomisation to receive one of three lots of SIIPL-PCV or to PHiD-CV in a ratio of 2:2:2:3. Parents and all staff assessing study outcomes were masked to group assignment. Vaccines (0·5 mL SIIPL-PCV or 0·5 mL PHiD-CV) were administered at ages 6, 10, and 14 weeks by intramuscular injection. Primary immunogenicity outcomes, measured at age 18 weeks, were serotype-specific IgG geometric mean concentrations (GMCs) and seroresponse rates (IgG ≥ 0·35 μg/mL). Lot-to-lot equivalence (objective 1) was shown if the upper and lower bounds of the two-sided 95% CI around the GMC ratio for each pairwise lot-to-lot comparison was between the 0·5 and 2·0 equivalence margins for all ten serotypes. The immunogenicity of SIIPL-PCV was defined as being non-inferior to that of PHiD-CV (objective 2) if, for at least seven of the ten serotypes in SIIPL-PCV, the lower bound of the 97·5% CI for the GMC ratio was greater than 0·5, or the lower bound of the 97·5% CI for differences in seroresponse rate was greater than -10%. The GMC and seroresponse rates to serotypes 6A and 19A, which are not in PHiD-CV, were compared with those of the serotype in PHiD-CV that had the lowest seroresponse rate. Non-inferiority of the immune responses to antigens in the co-administered Expanded Programme on Immunization (EPI) vaccines (objective 3) was declared if the lower bound of the 95% CI for the difference between SIIPL-PCV and PHiD-CV in seroresponse rates, or GMC ratios for pertussis antigens, was greater than -10% (or 0·5 for pertussis antigens) for all vaccine antigens. Safety data were assessed according to treatment received at the first visit in infants who received at least one dose of study vaccine and for whom at least some post-vaccination safety data were available. The primary immunogenicity analysis was in the per-protocol immunogenicity population, which included infants who received all study vaccines and had immunogenicity measurements after vaccination and no major protocol deviations. This trial is registered at ClinicalTrials.gov (NCT03197376).FINDINGSBetween June 21, 2017, and Jan 29, 2018, 2250 infants were enrolled and randomly assigned to receive SIIPL-PCV (n=1503; 502 to lot 1, 501 to lot 2, and 500 to lot 3) or PHiD-CV (n=747). 1458 (97·0%) infants assigned to SIIPL-PCV and 724 (96·9%) assigned to PHiD-CV were included in the per-protocol primary immunogenicity analysis. Lot-to-lot equivalence was shown, with the lowest lower bound of the 95% CI for the GMC ratio being 0·52 (for serotype 6B in lot 2 vs lot 3) and the highest upper bound being 1·69 (for serotype 6B in lot 1 vs lot 2). SIIPL-PCV was non-inferior to PHiD-CV in terms of immunogenicity: the lower bound of the 97·5% CI for the GMC ratio was greater than 0·5 (the lowest being 0·67 for serotype 19F) and the lower bound of the 97·5% CI for the difference in seroresponse rate was greater than -10% (the lowest being -2·2% for serotype 6B) for all ten serotypes in SIIPL-PCV. The lowest seroresponse rate after PHiD-CV was to serotype 6B (76·7% [95% CI 73·4-79·7]). This serotype was therefore used for the comparisons with serotype 6A and 19A in SIIPL-PCV. Non-inferiority of immune responses to the EPI vaccines after co-administration with SIIPL-PCV compared with after co-administration with PHiD-CV was shown for all vaccine antigens included in the primary series. The lowest lower bound of the 95% CI for the difference in seroresponse rates was -7·1% for rotavirus antibody and for the GMC ratio for pertussis antigens was 0·62 for anti-pertussis toxoid. 1131 (75·2%) of 1503 infants in the SIIPL-PCV group and 572 (76·6%) of 747 in the PHiD-CV group had at least one unsolicited adverse event. 36 (2·4%) participants in the SIIPL-PCV group and 18 (2·4%) in the PHiD-CV group had a serious adverse event; none were considered related to vaccination. In infants who were selected to have solicited adverse events recorded, injection-site induration after primary vaccinations occurred in 27 (4·9%) of 751 infants who received SIIPL-PCV versus 34 (9·4%) of 364 who received PHiD-CV (p=0·0032). There were no other notable differences in the safety profiles of the two vaccines. One infant in the SIIPL-PCV group and two in the PHiD-CV group died during the study. The deaths were not considered to be related to study vaccination or study participation.INTERPRETATIONThe immunogenicity of SIIPL-PCV was non-inferior to that of PHiD-CV, for which efficacy and effectiveness data against pneumococcal disease are available. The vaccine is safe and can be co-administered with routine EPI vaccines. The data generated in this trial have supported the licensure and pre-qualification of SIIPL-PCV, making the vaccine available for introduction into national immunisation programmes. Generating post-implementation data confirming vaccine impact remains important.FUNDINGBill & Melinda Gates Foundation.

2020-07-01·The Brazilian Journal of Infectious Diseases4区 · 医学

Pediatric bacterial meningitis and meningococcal disease profile in a Brazilian General Hospital

4区 · 医学

ArticleOA

作者: Ferronato, Angela E ; Blanco, Bruna P ; Yoshioka, Cristina R M ; Branas, Priscila C A A

OBJECTIVETo evaluate the clinical and epidemiological profile of bacterial meningitis and meningococcal disease in pediatric patients admitted to a Brazilian Secondary Public Hospital.METHODSA descriptive observational study was conducted. Microbiologically proven bacterial meningitis or meningococcal disease diagnosed from 2008 to 2018 were included.RESULTSA total of 90 patients were diagnosed with proven bacterial meningitis. There were 64 confirmed cases of meningococcal disease. The prevalence was higher in boys (n = 38), median age 30 months (1-185). The main clinical manifestations were: meningococcal meningitis (n = 27), meningococcemia without meningitis (n = 14), association of meningococcemia with meningitis (n = 13), and fever without a known source in infants (n = 7). Admissions to intensive care unit were necessary for 45 patients. Three deaths were notified. Serogroup C was the most prevalent (n = 32) followed by serogroup B (n = 12). Pneumococcal meningitis was identified in 21 cases; out of the total, 10 were younger than two years. The identified serotypes were: 18C, 6B, 15A, 28, 7F, 12F, 15C, 19A and 14. Pneumococcal conjugate 10-valent vaccine covered four of the nine identified serotypes. Haemophilus influenzae meningitis serotype IIa was identified in three patients, median age 4 months (4-7). All of them needed intensive care. No deaths were notified.CONCLUSIONMorbidity and mortality rates from bacterial meningitis and meningococcal disease remain high, requiring hospitalization and leading to sequelae. Our study observed a reduced incidence of bacterial disease over the last decade, possibly reflecting the impact of vaccination.

2020-04-01·Pediatrics

Efficacy and Effectiveness of the PCV-10 and PCV-13 Vaccines Against Invasive Pneumococcal Disease

Review

作者: Barker, Mackenzie ; Berman-Rosa, Melissa ; Quach, Caroline ; O’Donnell, Shauna

CONTEXT:Pneumococcal conjugate vaccines (PCVs) (pneumococcal 13-valent conjugate vaccine [PCV-13] and pneumococcal 10-valent conjugate vaccine [PCV-10]) are available for prevention of pneumococcal infections in children.OBJECTIVE:To determine the vaccine effectiveness (VE) of PCV-13 and PCV-10 in preventing invasive pneumococcal disease (IPD) and acute otitis media (AOM) in children <5 years.DATA SOURCES:Systematic searches of Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Cochrane.STUDY SELECTION:Eligible studies examined the direct effectiveness and/or efficacy of PCV-10 and PCV-13 in reducing the incidence of disease in healthy children <5 years.DATA EXTRACTION:Two reviewers independently conducted data extraction and methodologic quality assessment.RESULTS:Significant effectiveness against vaccine-type IPD in children ≤5 years was reported for ≥1 dose of PCV-13 in the 3 + 1 (86%–96%) and 2 + 1 schedule (67.2%–86%) and for PCV-10 for the 3 + 1 (72.8%–100%) and 2 + 1 schedules (92%–97%). In children <12 months of age, PCV-13 VE against serotype 19A post–primary series was significant for the 3 + 1 but not the 2 + 1 schedule. PCV-10 crossprotection against 19A was significant in children ≤5 years with ≥1 dose (82.2% and 71%). The majority of studies did not find either PCV to be effective against serotype-3. PCV-13 was effective against AOM (86%; 95% confidence interval [CI]: 61 to 94). PCV-10 was effective against clinically defined (26.9%; 95% CI: 5.9 to 43.3) and bacteriologically confirmed AOM (43.3%; 95% CI: 1.7 to 67.3).LIMITATIONS:Because of the large heterogeneity in studies, a meta-analysis for pooled estimates was not done.CONCLUSIONS:Both PCVs afford protection against pneumococcal infections, with PCV-10 protecting against 19A IPD, but this VE has not been verified in the youngest age groups.

100 项与 Pneumococcal vaccine conjugate 10-valent(Panacea Biotec Ltd.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
乙型流感病毒感染	临床3期	波兰	GSK Plc	2009-08-13
脊髓灰质炎	临床3期	波兰	GSK Plc	2009-08-13
破伤风	临床3期	波兰	GSK Plc	2009-08-13
百日咳	临床3期	波兰	GSK Plc	2009-08-13
甲型肝炎	临床3期	智利	GSK Plc	2006-04-01
链球菌感染	临床3期	法国	GSK Plc	2005-11-01
链球菌感染	临床3期	芬兰	GSK Plc	2005-11-01
链球菌感染	临床3期	波兰	GSK Plc	2005-11-01
肺炎	临床3期	-	Panacea Biotec Ltd.	-