A clinical trial to evaluate immunogenicity and safety of Live Varicella vaccine (Oka Strain) in Indian children.

"Multicentric, Phase II/III clinical trial study for evaluation of safety and immunogenicity of Live Varicella vaccine (Oka Strain) versus reference vaccine in Indian children". - PROTOCOL STUDY NO BM/BIOPOX/CT/01

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/03/004445

Enrollment

252

Registered

2014-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Varicella Vaccine,Live,I.P., BIOPOX?: 0.5ml/dose administered subcutaneously as a single dose to the subjects Control Intervention1: VHB Life Sciences Ltd.,Varivax: 0.5ml/dose administe

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject should be a healthy child as assessed by history, physical examination and clinical judgment of the investigator. 2.Age of subject should be between one to twelve years. 3.Subject should be of Indian origin and will remain in the study area for the length of the trial. 4.Subject should give written inform consent. 5.Subject should be aware of full information regarding the vaccine and clinical trial.

Exclusion criteria

Exclusion criteria: 1.History of chicken pox disease. 2.Subject is suffering from fever, diarrhoea and sign of acute infection. 3.Subject is having a history of vaccination with chicken pox vaccine. 4.Subject is having a history of disease, drug intake (like anti-malarial, steroids, phenytoin, anti-inflammatory drugs or immunosuppressive drugs) in the past two weeks of proposed vaccination date. 5.Subject is having a history of allergy or hypersensitivity to any component of the vaccine. 6.Subject is having immunodeficiency or an auto-immune disease. 7.Subject is having a history of adverse reactions during previous vaccination. 8.Subject is participating in any other study at the same time or during the past three months. 9.Subject is planning surgery during the study period. 10.Subject is likely to move out of station during the study period.

Design outcomes

Primary

Measure	Time frame
Evaluation of seroconversion in subjects (Seroconversion is defined as the rise in post vaccination antibody titre in comparision to the pre-vaccination antibody titre.Timepoint: 42Â±7 days	—

Secondary

Measure	Time frame
Evaluation of the safety aspects of the vaccineTimepoint: 42Â±7 days	—

Countries

India

Contacts

Public ContactDr S P Garg

Biomed Private Limited

bmvaccine@yahoo.com0120-6451780

Outcome results