None listed
Conditions
Interventions
Intervention1: vaccination: single dose
Control Intervention1: Nil: Nil
Sponsors
Green Signal BioPharma Pvt. Ltd., Chennai, India
Azidus Laboratories Ltd, Chennai, India
Eligibility
Inclusion criteria
Inclusion criteria: * 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.
Exclusion criteria
Exclusion criteria: * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityTimepoint: at 30 minutes, 3rd day and during 6th week after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of vaccination site wound healingTimepoint: at 30 minutes, 3rd day and during 6th week after vaccination | — |
Countries
India
Contacts
Public ContactArunkumar
Outcome results
None listed