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临床试验/CTRI/2014/04/004532
CTRI/2014/04/004532已完成4 期

A Phase IV, Randomized, factorial assigned, Open labelled, study to evaluatethe non- interference in immune response of Typhoid Vi Capsular Polysaccharide - Tetanus Toxoid Conjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measles vaccine given concomitantly

Bharat Biotech International Ltd6 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年4月15日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
500
试验地点
6
主要终点
To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the

研究概览

简要总结

Typhoidfever continues to be important causes of illness and death, particularly amongchildren and adolescents in south-central and Southeast Asia, where enteric fever is associated with poor sanitation andunsafe food and water. High-quality incidence data from Asiaare underpinning efforts to expand access to typhoid vaccines. Efforts areunderway to develop vaccines that are immunogenic in infants after a singledose and that can be produced locally in countries of endemicity. Antimicrobialresistance has sequentially emerged to traditional first-line drugs, fluoroquinolones,and third-generation cephalosporins, posing patient treatment challenges. The Viconjugate typhoid vaccine, Typbar-TCV under clinical trial have been found tobe highly immunogenic in infants and children less than 2 years of age in whichunconjugated Vi polysaccharide typhoid vaccine is known to induce very low ornil immunogenic response.

EarlyImmunizations not only prevent mortality and morbidity but also reduce the expenditureof public and private resources. Introduction of Typhoid vaccine with measles vaccineat 9 months of age in routine EPI programs will not substantially interfere withmeasles elimination programs and will eliminate the need of an additionaltyphoid vaccination visit in the already clustered initial EPI Immunizationvisits. The current study proposed to evaluate immunogenicity and safety whenco-administered with measles vaccine. The objectiveis to determine whether TCV can be successfully co-administered with Measleswithout interfering with the immune response to each of these antigens.

This openlabeled, randomized, parallel study to evaluate the non- interference in immuneresponse of one dose of Typhoid Vi Capsular Polysaccharide-Tetanus ToxoidConjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measlesvaccine given concomitantly.

Thesubjects will be screened for eligibility in to the study after obtainingwritten informed consent from the subject. Screening period might last for 7days. Screening includes obtaining medical history, physical examination,demographic details (weight, height & gender), Vital signs (Heart rate,respiratory rate, body temperature-oral or axillary) and clinical evaluations.

Aftercompletion of the screening process, the eligible, subjects shall be enrolledinto the study groups. Subjects shall be observed for 30 minutes aftervaccination, and for the next 7 days, recorded in the subject diary cards.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
8.00 Month(s) 至 10.00 Month(s)(—)
性别
All

入选标准

  • 1.Parents or Legally Acceptable Representative willing to give signed Informed Consent.
  • Infants aged 8 to 10 months.
  • Subjects should be available for the next 2 years for followup.
  • Subject, who has not received Measles vaccine or Typhoid vaccine.
  • Subjects are not currently participating in any other clinical trial or are in receipt of any other Investigational product in the last 06 months.

排除标准

  • 1.Presence of any illness requiring hospital referral on the day of Vaccine administration, temporary exclusion.
  • Known immunodeficiency.
  • Receipt of Blood products in the last 06 months.
  • 4.Known case of HIV or other major Immunological abnormalities.
  • In receipt of Systemic Immunosuppressant or systemic cortico-steroids.
  • Any household contact on Immunosuppressant.
  • Known allergy to any component of the Vaccine.

结局指标

主要结局

To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the

时间窗: To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the | immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) | 2.To determine the effect (anti-Vi antibodies) of booster dose | administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)

immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B)

时间窗: To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the | immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) | 2.To determine the effect (anti-Vi antibodies) of booster dose | administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)

2.To determine the effect (anti-Vi antibodies) of booster dose

时间窗: To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the | immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) | 2.To determine the effect (anti-Vi antibodies) of booster dose | administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)

administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)

时间窗: To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the | immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) | 2.To determine the effect (anti-Vi antibodies) of booster dose | administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)

次要结局

  • GMTs of serum Vi antibodies and proportion that seroconvert((four fold rise in titres to serum Vi antibodies))

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (6)

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