A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

开始日期2009-08-01

申办/合作机构-

100 项与 Diphtheria, tetanus, pertussis, Haemophilus influenzae b vaccine(Novartis Pharma AG) 相关的临床结果

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100 项与 Diphtheria, tetanus, pertussis, Haemophilus influenzae b vaccine(Novartis Pharma AG) 相关的转化医学

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100 项与 Diphtheria, tetanus, pertussis, Haemophilus influenzae b vaccine(Novartis Pharma AG) 相关的专利（医药）

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项与 Diphtheria, tetanus, pertussis, Haemophilus influenzae b vaccine(Novartis Pharma AG) 相关的文献（医药）

2016-08-02·Human Vaccines & Immunotherapeutics3区 · 医学

What timing of vaccination is potentially dangerous for children younger than 2 years?

3区 · 医学

Article

作者: Martinot, Alain ; Gras, Pauline ; Dervaux, Benoit ; Bailly, Anne-Charlotte ; Dubos, François ; Lagrée, Marion

Vaccine-preventable diseases still occur although measured coverage rates at 2 y of age are high. The occurrence of these diseases may be explained in part by untimely, that is, late vaccination. Our objective was to identify potentially dangerous vaccination delays for each dose of each vaccine in children younger than 2 y. A 3-round Delphi process was conducted by e-mail. We recruited 37 French experts in vaccines for children: 16 from the Infovac-France group and 21 from the French study group for pediatric infectious diseases. Items were generated by a literature review for the 10 vaccine doses recommended before 2 y of age. Item reduction in round 1 and 2 and any consensus in round 3 used a 70% consensus cutoff. The mean participation rate was 79%. Delays that should not be exceeded were identified for all vaccine doses. The 70% consensus was reached for 6 of the 10 vaccine doses: 15 d after the recommended date for the first 2 doses of the diphtheria-tetanus-acellular pertussis-inactivated polio vaccine/Haemophilus influenzae b vaccine and for the second dose of the pneumococcal conjugate vaccine, 1 month for the meningococcal C vaccine and for the first dose of the measles-mumps-rubella vaccine, and 11 y of age for completion of the hepatitis B vaccination. This Delphi process identified potentially dangerous vaccination delays for children to the age of 2 y. These can be used as new indicators in further studies of vaccine effectiveness and can help to improve the quality of vaccine protection in children.

2012-02-01·Vaccine3区 · 医学

Measles control in Sub-Saharan Africa: South Africa as a case study

3区 · 医学

Article

作者: Waasila Jassat ; Stephen Tollman ; Calle Hedberg ; Dean T. Jamison ; Stéphane Verguet ; Karen J. Hofman

BACKGROUNDDue to intensified measles immunization efforts, measles mortality has decreased substantially worldwide, particularly in Sub-Saharan Africa (SSA). The World Health Organization (WHO) estimated a 92% decrease in measles-related deaths in the WHO AFRO region for the period 2000-2008. Recently, the AFRO region established a measles pre-elimination goal and experts have suggested engaging in a measles eradication campaign at the global level. However, recent large-scale outbreaks in many Sub-Saharan African countries present a challenge to measles control efforts. This paper examines measles immunization and the impact of measles supplemental immunization activities (SIAs) on routine immunization coverage in South Africa (SA).METHODSWe reported on immunization coverage trends in SA for the period 2001-2010 at the province and district levels. The data included routine immunization for 1st and 2nd doses of measles vaccine (MCV1, MCV2), SIAs, 1st dose of Bacille Calmette-Guérin vaccine, 1st and 3rd doses of oral polio vaccine (OPV1, OPV3), 3rd dose of Diphtheria-Tetanus-Pertussis-Haemophilus-influenzae-B vaccine (DTP-Hib3), and the number of under-one-year-olds having completed a primary course of immunization (Imm1). A regression model looked at the SIA impact on routine coverage.RESULTSOver the past decade, MCV1 and MCV2 coverage have increased nationally from 68% and 57% in 2001 to 95% and 83% in 2010, respectively. SIA coverage has remained at high levels, around 90%, over the same period. Substantial heterogeneity in MCV1 and MCV2 coverage is present across SA districts, with differences in coverage of 56% (MCV1) and 51% (MCV2) in 2010. In any given year, occurrence of SIAs was associated with a decrease in routine immunization coverage of MCV1, MCV2, OPV1, OPV3, DTP-Hib3, and Imm1, at the district level.CONCLUSIONSThe heterogeneity in measles vaccination coverage across SA districts challenges the goal of measles elimination in SA and SSA. The reduction in routine immunization coverage associated with the occurrence of SIAs raises the legitimate concern that SIAs may negatively impact health systems' functioning.

2011-10-01·Vaccine3区 · 医学

Immunogenicity and safety of a Haemophilus influenzae B (Hib)–hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants

3区 · 医学

Article

作者: Christopher L. Gilbert ; Stephanie O. Klopfer ; Florian P. Schödel ; Timo Vesikari ; Andrew W. Lee ; Prakash K. Bhuyan

BACKGROUNDA hepatitis B vaccine was manufactured with a modified process (mpHBV) that incorporated double the usual amount of phosphate. Following a study in young adults, the mpHBV was evaluated in infants in a combination hepatitis B and Haemophilus influenzae B vaccine (mpHBV-Hib).METHODSThe mpHBV-Hib was compared with the licensed bivalent HBV-Hib vaccine Comvax™ for immunogenicity and safety. Both vaccines contained 5 μg/0.5 mL of hepatitis B surface antigen (HBsAg) and 7.5 μg/0.5 mL of PRP-OMPC (polyribosylribitol phosphate outer membrane protein complex). A total of 543 infants were randomized 1:1 to receive either vaccine at 2, 4 and 12 months of age. A pneumococcal conjugate vaccine (PCV) was given concomitantly. Immunogenicity was assessed at 1-month post-dose 3.RESULTSSeroprotection rates [% subjects with anti-hepatitis B surface antigen antibody titers (anti-HBs) ≥10 mIU/mL)] were 100% and 99% for mpHBV-Hib and the licensed control (Comvax™), respectively. Anti-HBs geometric mean titers (GMTs) were 4204 (95% CI, 3411-5182) and 1683 (95% CI, 1350-2099) mIU/mL, respectively. Anti-PRP seroprotection rates (SPR) at ≥0.15 μg/mL and at ≥1.0 μg/mL were 97% and 94%, respectively, for mpHBV-Hib and 96% and 92%, respectively, for the control. Anti-PRP GMTs were 7.1 μg/mL for mpHBV-Hib and 8.0 μg/mL for the control. Reactogenicity of the two vaccines was similar.CONCLUSIONSThe mpHBV in combination with Hib and with co-administered PCV was highly immunogenic. The safety profile of mpHBV-Hib was comparable to the licensed control. Both the control and mpHBV-Hib met acceptability criteria for seroprotection rates to hepatitis B, with higher anti-HBs GMTs noted for mpHBV-Hib.

100 项与 Diphtheria, tetanus, pertussis, Haemophilus influenzae b vaccine(Novartis Pharma AG) 相关的药物交易

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