A Post Marketing Surveillance study of BCG vaccine in Indian populatio
- Registration Number
- CTRI/2009/091/000669
- Lead Sponsor
- Green Signal BioPharma Pvt. Ltd., Chennai, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerabilityTimepoint: at 30 minutes, 3rd day and during 6th week after vaccination
- Secondary Outcome Measures
Name Time Method Assessment of vaccination site wound healingTimepoint: at 30 minutes, 3rd day and during 6th week after vaccination