Clinical trial NCT01250249: A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.
Official title: A Randomized, Open Label, Single-period, Single-treatment, Controlled Multi Center Phase Iii Study of Comparing Safety and Reactogenecity of Lyophilized BCG Vaccine ip (0.1 mg in 0.1 ml) of Green Signal Bio Pharma Private Limited India With BCG Vaccine (0.1 mg in 0.1 ml) of Serum Institute of India Limited (SIIL),India in 120 Healthy Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited with BCG vaccine of serum institute of India limited
Lead sponsor: Green Signal Biopharma Private Limited
Sponsor class: INDUSTRY
First posted: 2010-11-30
Enrollment: 120
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy children.

Detailed description: The study was conducted in the objective to compare the safety and reactogenecity of BCG Vaccine of Green Signal Bio pharma Private Limited India(Test) with BCG vaccine of Serum Institute of India(Reference) in 120 healthy children.

The above study was conducted in multi centers(2 centers - Chennai \& Bangalore). The study was conducted as per the protocol approved by DCGI and Madras ethical Committee.

A single dose was administedred to all the subjects and it was inferred that all the 120 subjects vaccinated were safe. Further, the reactogenecity was confirmed after 90th day by PPD administration to all the subjects. Based on the above observations it was well identified that test vaccine can be safely administered to children and it is well tolerated and accepted by the subjects. More over statistically it is inferred that there is no significant variation between the test and reference vaccine.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be in the age group of 0 - 14 years of age.
2. Subject's parent should be able to understand and have to sign the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects and risks.
3. Ability to comply with the schedule of treatment and follow-up.
4. Absence of BCG scar
5. Tuberculin negative
6. No evidence of any other infection
7. No evidence of skin disease -

Exclusion Criteria:

History or presence of significant:

Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.

More specifically, history or presence of significant:

Low birth weight babies (\<2.5 Kg),

Malignancy,

Tuberculin positive,

Hodgkin's disease,

Corticosteroid therapy,

Generalised Eczema,

Infective dermatosis,

Hypogammaglobulinemia,

Immunosuppressed,

Above 14 years of age,

On anti-tubercular drugs,

Chest X ray evidence of TB.

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Arya vysya maternity home & child welfare centre
state: Tamilnadu
Study officials:
affiliation: KC General Hospital, Malleswaram, Bangalore
name: SR Lakshimipathy, MBBS, DCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Arya vysya maternity home & child welfare centre
name: Mohamed Kizhar Irshat, MBBS, DCH
role: PRINCIPAL_INVESTIGATOR
References: