A Multicentre, Open label, Prospective, Single treatment, Single dose, Post Marketing Surveillance study to evaluate the safety and tolerability of Lyophilized BCG vaccine IP of Green Signal BioPharma Pvt. Ltd, Chennai, India.

Green Signal BioPharma Pvt. Ltd., Chennai, India0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•* Male and female new born babies with the age of less than one month
•- Healthy babies as evaluated by personal & medical history, general and systemic examination
•- Babies with the body weight of more than 2 kgs
•- Babies having minimum 34 weeks of intrauterine gestational period
•- Mother being negative to HIV 1 & 2, Hepatitis B & C
•* Male and female infants with the age of one month, but less than one year
•- Healthy babies as evaluated by personal & medical history, general and systemic examination
•- Babies with the body weight proportionate to the age and judged to be acceptable in view of the physician
•- Mother being negative to HIV 1 & 2, Hepatitis B & C
•* Male and female children with the age of 1 to 14 yrs
•- Healthy children as evaluated by personal & medical history, general and systemic examination
•- Children being negative for Tuberculin test
•- Normal Hematological and urinary parameters and chest X ray (or Clinically insignificant deviations in view of the physician)
•- Negative for HIV 1 & 2, Hepatitis B & C
•* Apart from the age specific inclusion criteria, the following criteria are generally applicable
•- Parents willing to give informed consent and comply with study requirements
•- Absence of BCG vaccine scar
•- In the best interest of the child?s health, the physician may recruit any potential subject who is otherwise likely to get rejected from vaccination.

•* Male and female new born babies with the age of less than one year
•- Babies with prolonged umbilical cord bleeding (only for babies upto one month old)
•- Parents having tuberculosis
•* Male and female children with the age of 1 to 14 yrs
•- Positive Tuberculin test
•- Positive for HIV 1 & 2, Hepatitis B & C
•- Abnormal hematological & urinary parameters and / or chest X ray
•* Apart from the age specific exclusion criteria, the following are applicable generally
•- Babies considered to be very sick (in view of the physician)
•- Having localized or systemic infections
•- History suggestive of or Diagnosed of having Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunological, dermatological, neurological or psychiatric disorders
•- Subjects having acute or chronic febrile conditions
•- Receiving immunosuppressants including corticosteroids and anti tubercular drugs
•- Hypersensitivity reaction to the vaccine
•- In the best interest of the child?s health, the physician may reject any potential subject who is otherwise eligible for vaccination.

发起方

Green Signal BioPharma Pvt. Ltd., Chennai, India