A Phase-I Clinical Trial to study the Safety and efficacy of Bharat Biotech International Limited Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) in healthy volunteers.
- Registration Number
- CTRI/2010/091/000152
- Lead Sponsor
- Bharat Biotech International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
1.Healthy male or female volunteers aged between 18 to 65 years inclusive
2.Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination
3.The subject must be in good health as determined by medical history, physical examination and laboratory screening tests
4.Subject must be willing and able to comply with planned study procedures and be available for all study visits
5.Subject must provide written informed consent prior to initiation of any study procedures, and subject may provide written assent as appropriate
6.Subjects willing to stay for entire study duration and follow-up period in the current residential address
1.Allergy to components of the vaccine including, thiomersal, and aluminum hydroxide
2.Has a history of previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis
3.Female with positive urine pregnancy test within 24 hours prior to vaccination or breastfeeding or unwilling to undergo pregnancy testing
4.History of smoking 20 pack-years or greater
5.Has received anticancer chemotherapy or radiation therapy (cytotoxic) within the past 36 months
6.Has an active neoplastic disease or a history of any hematologic malignancy
7.Known history of a bleeding disorder contraindicating intramuscular vaccination
8.History of schizophrenia, bipolar disease, suicidal attempt, major psychiatric illness or confinement for danger to self or others
9.History of receiving immunoglobulin, anti-cytokine antibodies, immunosuppressants, immune modifying agents or other blood product within the 3 months prior to vaccination in this study
10.Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 3 months prior to vaccination in this study or expected to receive an experimental agent during this study
11.Has received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study, or plan receipt of such vaccines within 21 days following the second vaccination
12.Has an acute illness, including an oral temperature greater than >370C, 1 week before the vaccination
13.Has a chronic neurologic or autoimmune disorder
14.Has a history of Guillain-Barré Syndrome
15.Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of vaccine response
16.Participated in a novel influenza H1N1 vaccine study in the past two years or has a history of novel influenza H1N1 2009 infection or treatment
17.Has known active HIV, Hepatitis B or Hepatitis C infection
18.Has a history of alcohol or drug addiction in the last 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Occurrence of solicited and unsolicited local AEs within 7 days post vaccination by age group and overall from Days 0 to 7. <br/ ><br>2. Occurrence of solicited and unsolicited systemic AEs within 21 days post vaccination by age group and overall on Days 0, 7, 21, <br/ ><br>3. Occurrence of vaccine-associated SAEs throughout the course of the study by age group and overall.Timepoint: Throughout Study Duration
- Secondary Outcome Measures
Name Time Method 1.Proportion of participants achieving 4-fold or greater HAI antibody titer increase against the novel influenza H1N1 virus following single dose of BBIL H1N1 vaccine groups on day 21<br>2.Proportion of participants achieving a serum HAI antibody titer of 1:40 or greater against the novel influenza H1N1 virus following single dose of BBIL H1N1 vaccine groups on Days 21.<br>3.GMT in each group on day 0 and 21.<br>Timepoint: 21 days post vaccination