| CTRI Number |
CTRI/2010/091/000152 [Registered on: 02/03/2010] |
| Last Modified On: |
13/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
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. |
Scientific Title of Study
Modification(s)
|
A Phase I, Randomized, Double Blind, Placebo Controlled and Parallel Assignment Study to Evaluate the Safety and Efficacy of H1N1 Vaccine With or Without ajuvant Produced by BBIL in healthy volunteers. Acronym Influenza A H1N1 pandemic 2009 Vaccine(Inactivated)
|
| Trial Acronym |
H1N1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/H1N1/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr VH Basavaraj |
| Designation |
Professor of Medicine |
| Affiliation |
|
| Address |
Vydehi Hospital, 82, EPIP Area, White Field, Bangalore.
Bangalore
KARNATAKA
560066
India |
| Phone |
919880205953 |
| Fax |
918028412956 |
| Email |
drbasavarajvh@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Santhosh Kumar M |
| Designation |
Asst Medical Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech
Genome Valley
Shameerpet
Hyderabad
Hyderabad
ANDHRA PRADESH
500078
India |
| Phone |
919989422803 |
| Fax |
914023480560 |
| Email |
madhusudhansk@bharatbiotech.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Santhosh Kumar M |
| Designation |
Assistant medical Director |
| Affiliation |
|
| Address |
Bharat Biotech
Genome Valley
Shameerpet
Hyderabad
Hyderabad
ANDHRA PRADESH
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
madhusudhansk@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat Biotech International Limited,
Genome Valley, Shameer Pet,
Ranga Reddy (Distict),
Hyderabad-500 078.
|
|
Primary Sponsor
Modification(s)
|
| Name |
Bharat Biotech International Limited |
| Address |
Genome Valley
Shameerpet
Hyderabad |
| Type of Sponsor |
Other [Biopharmaceutical Company] |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. V.H. Basavaraj |
Vydehi Institute of Medical Sciences & Research Center |
#82, EPIP Area, White Field, Bangalore,-560066
Bangalore
KARNATAKA |
+9180-2366 3208
+9180 ? 2841 2956
drbasavaraj@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Review Board, VIMS & RC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Influenza A H1N1 pandemic 2009 infection. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A H1N1 pandemic 2009 Vaccine (Inactivated) - HNVAC |
Single dose, 0.5ml, 15mcg(Adjuvanted & Non-adjuvanted) |
| Comparator Agent |
Placebo |
Single dose, 0.5mL. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Occurrence of solicited and unsolicited local AEs within 7 days post vaccination by age group and overall from Days 0 to 7.
2. Occurrence of solicited and unsolicited systemic AEs within 21 days post vaccination by age group and overall on Days 0, 7, 21,
3. Occurrence of vaccine-associated SAEs throughout the course of the study by age group and overall. |
Throughout Study Duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
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.
3. GMT in each group on day 0 and 21.
|
21 days post vaccination |
|
Target Sample Size
Modification(s)
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
20/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Phase I, Randomized, Double Blind, Placebo Controlled and Parallel Assignment Study to Evaluate the Safety and Efficacy of Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) With or Without Adjuvant Produced by Bharat Biotech International Limited in healthy volunteers in 160 healthy volunteer in one center in India. The primary objective of the study is to evaluate the safety of the cell cultured Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) vaccine with or without an Adjuvant in healthy volunteers of 18 to 65 years. The secondary objective is to assess and obtain immunogenicity data of the cell cultured Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) with or without an Adjuvant in healthy volunteers of 18 to 65 years. |