CTRI/2012/07/002820已完成1/2 期
A Phase I/II Study of the All In One Liquid Formulation of a Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) to Sequentially Evaluate the Safety and Tolerability of a Single Dose in Healthy Adult Volunteers Followed by Evaluation of the Safety, Tolerability and Immunogenicity (Dose Response) of a Three Administration Series in Healthy Infants in India.
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Cohort 1 (Healthy Adults)
研究概览
简要总结
This study would be conducted sequentially in two cohorts. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Cohort 1 would be of 20 healthy adults administered a single dose of highest dose planned of the Live Attenuated Tetravalent Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) or placebo. The volunteers would be randomized in ratio of 3:1 to receive either a single dose of the BRV-TV vaccine or placebo and will be followed for 10 days for any AE/SAEs.
Cohort 2 would be a Phase I/II, randomized controlled, single-blind, dosage selection and comparative study to describe the safety, tolerability, and immunogenicity of a 3-dose series of either the Live Attenuated Tetravalent Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) or RotaTeq or Placebo administered along with the routine childhood vaccines in healthy Indian infants and will be followed for 28 days after each dose for any event of AE/SAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.50 Month(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Adults: •Healthy Indian adult volunteers between 18 to 55 years of age.
- •â€¢No apparent signs or symptoms of ill health.
- •â€¢Properly informed about the study and having signed the informed consent form (ICF).
- •In case of the volunteer being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF; •Subject available for the entire period of the study and reachable by study staff for post vaccination follow-up.
- •Healthy Infants: •Healthy infants, of either sex, 6-8 weeks of age at time of enrollment; •Born after a gestational period of 36-42 weeks with birth weight ≥2kg; •Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).
- •In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF; •Infant/Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
排除标准
- •Healthy adults: •Known or suspected impairment of immunological function; •Known hypersensitivity to any component of the rotavirus vaccine; •Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
- •â€¢History of chronic diarrhea; •Clinical evidence of active gastrointestinal illness; •Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days •Subjects suspected to be HIV, HBV or HCV positive from the available clinical history •Any subject who cannot be adequately followed for safety; •Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •â€¢Subject unable to maintain diary card •Participation in another clinical trial investigating a vaccine, drug, medical device or medicinal procedure in the 4 weeks preceding the trial vaccination.
- •â€¢Planned participation in another clinical trial during the present trial period.
- •â€¢Volunteers identified as employees of the investigator or study center, with direct involvement in the proposed study or studies under the direction of that investigator or study center as well as children, adopted or natural, of the employees or Investigator.
- •Healthy Infants: •History of congenital abdominal disorders, intussusception, or abdominal surgery; •Infants exhibiting signs of severe malnutrition Known or suspected impairment of immunological function in subject or immediate family; •Developmental delay or Neurological disorder •Known hypersensitivity to any component of the rotavirus vaccine; •Prior receipt of any rotavirus vaccine; •Prior receipt of any dose of Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib or polio virus containing vaccine(s).
- •Birth dose of Hepatitis B and Oral Polio Vaccine is allowed to be administered to the infants as per the local immunization practices.
- •Oral Polio Vaccines administered as a part of the National Pulse Polio Program are allowed to be administered to the infants.
- •â€¢Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
- •â€¢History of known rotavirus disease, chronic diarrhea, or failure to thrive; •Baseline level of ALT or AST 2.5 times the upper limit of normal; •Clinical evidence of active gastrointestinal illness including ongoing diarrheal episode (infants with GERD can participate in the study so long as this condition is well controlled with or without medication); •Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study); •Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephritic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids); •Infants already laboratory confirmed or suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive.(no specific screening for the purpose of the study would be carried out) •Prior receipt of a blood transfusion or blood products, including immunoglobulins, in the past 4 weeks which might interfere with the assessment of the immune response; •Any infants who cannot be adequately followed for safety by a home visit; •Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •â€¢Parent/s or guardian of infant unable to maintain symptom diary •Participation in another clinical trial investigating a vaccine, drug, medical device or medicinal procedure in the 4 weeks preceding the trial vaccination.
- •â€¢Parents/ Guardians/ Legally Accepted Representatives identified as employees of the investigator or study center, with direct involvement in the proposed study or studies under the direction of that investigator or study center as well as children, adopted or natural, of the employees or Investigator.
结局指标
主要结局
Cohort 1 (Healthy Adults)
时间窗: Cohort 1 (Healthy Adults) | 1O days post vaccination | Cohort 2 (Healthy Infants) | 28 days post 3rd dose of vaccination
Frequency, severity, and causality of REs and other AEs following the dose of Investigational Rotavirus Vaccine as compared to REs and AEs reported for adults administered a single dose of Placebo.
时间窗: Cohort 1 (Healthy Adults) | 1O days post vaccination | Cohort 2 (Healthy Infants) | 28 days post 3rd dose of vaccination
Cohort 2 (Healthy Infants)
时间窗: Cohort 1 (Healthy Adults) | 1O days post vaccination | Cohort 2 (Healthy Infants) | 28 days post 3rd dose of vaccination
Sero-response rate at each antigen concentration level of Investigational Rotavirus vaccine/ Rotateq/Placebo
时间窗: Cohort 1 (Healthy Adults) | 1O days post vaccination | Cohort 2 (Healthy Infants) | 28 days post 3rd dose of vaccination
次要结局
- Cohort 2 (Healthy Infants)(•Frequency, severity, and causality of REs and other AEs following the dose of Investigational Rotavirus Vaccine /Rotateq/Placebo)
研究者
研究点 (3)
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