| CTRI Number |
CTRI/2014/08/004856 [Registered on: 11/08/2014] Trial Registered Prospectively |
| Last Modified On: |
23/10/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF INACTIVATED TRIVALENT INFLUENZA VACCINE (SPLIT VIRION) |
|
Scientific Title of Study
|
AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, CLINICAL PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF INACTIVATED TRIVALENT INFLUENZA VACCINE (SPLIT VIRION) OF M/s CADILA HEALTHCARE LTD., INDIA IN HEALTHY, ADULT, MALE, HUMAN SUBJECTS. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| INZT 1001 Ver 01 dated 3 Oct 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Principal Investigator |
| Affiliation |
Zydus Research Centre |
| Address |
Zydus Research Centre. Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
02717665355 |
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Jani |
| Designation |
Sr Vice President |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Limited Zydus Cadila House, Plot No.360, TPS 5, DayaldasRoad Service Road Crossing VileParle(E) Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
26180652 |
| Fax |
26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Jani |
| Designation |
Sr Vice President |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Limited Zydus Cadila House, Plot No.360, TPS 5, DayaldasRoad Service Road Crossing VileParle(E) Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
26180652 |
| Fax |
26151735 |
| Email |
rhjani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Zydus Research Centre. Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382213, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Ltd. Sigma Commerzone (1stFloor), Ambli-Bopal road, Satellite, Ahmedabad – 380 015, Gujarat, INDIA. Tel. No.: 079-2686 8926 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kevinkumar Kansagra |
Zydus Research Centre |
Zydus Research Centre Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382213
Ahmadabad
GUJARAT |
02717-665555
02717-665355
kevinkumarkansagra@zyduscadila.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics committee of care Institute of Medical Sciences |
Approved |
| Ethics committee of care Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult male human volunteers |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Inactivated Trivalent Influenza Vaccine (Split Virion) of M/s. Cadila Healthcare Ltd. |
Each dose of 0.5 ml vaccine (Split virion) contains following strains:
A/California/2009/(H1N1)-Like Virus: ≥15 mcg of HA
A/Victoria/361/2011/H3N2-Like Virus: ≥15 mcg of HA
NYMC BX – 51 B: ≥15 mcg of HA.
The subjects will be administered a single Intramuscular (I.M.) dose of 0.5 ml of the vaccine into the Upper arm. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
-Subjects’ weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
-Ability to communicate effectively with study personnel.
-Willingness to adhere to the protocol requirements.
-Be able to give consent for participation in the trial.
-Normal health as determined by personal medical history, clinical examination and laboratory examinations data during screening (within the clinically acceptable range). |
|
| ExclusionCriteria |
| Details |
-History of anaphylaxis or serious reactions to vaccines, egg proteins, gelatin or gelatin containing product.
-Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
-Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive.
-Subjects who have received immunoglobulins parenterally during the preceding 3 months.
Subjects who have received any vaccine in the preceding 6 months.
-History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
-History or presence of significant alcoholism or drug abuse within the past one-year.
-History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.
-Difficulty with donating blood.
-Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90(Systolic/diastolic) mm Hg.
-Pulse less than 60/minute or more than 110/minute.
-Febrile.
-Any ECG abnormalities.
-Any clinically significant abnormal laboratory values during screening.
-Any clinically significant chest X-Ray findings during screening.
-Major illness during 3 months before the screening period
-Subjects who have participated in drug research studies within past 3 months.
-Subjects who have donated one unit (350ml) of blood in the past 3 months.
Also subjects will be assessed for alcohol and drug of abuse consumption at the time of check in during the study. Subjects who are found positive in alcohol breathe test and urine test for drug of abuse, will not be enrolled in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of Inactivated Trivalent Influenza Vaccine (Split Virion) of M/s. Cadila Healthcare Ltd., India given Intramuscularly in healthy adult male human subjects. |
Vital signs like oral temperature, sitting blood pressure and radial pulse will be measured and recorded during subject check-in, prior to administration of dose, 1.00, 2.00, 6.00 and 12.00 hours after administration of dose and at check-out.
Clinical examination of the subjects will be done at the time of check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42 during the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
NA |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/08/2014 |
| 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
|
Years="0"
Months="1"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an an open-label, single-treatment, single-period, single dose, phase 1 clinical study in healthy, adult, male, human subjects.
Objective of this study is to assess the safety and tolerability of Inactivated Trivalent Influenza Vaccine (Split Virion) of M/s. Cadila Healthcare Ltd., India given Intramuscularly in healthy adult male human subjects.
The subjects will be administered a single Intramuscular (I.M.) dose of 0.5 ml of the vaccine into the Upper arm. The subjects will be housed at the clinical facility from not less than 11 hours pre-dose till 24-hour post-dose during the study period.
Blood sample for safety purpose will be collected on day 21 during the study through disposable syringes and needles. Vital signs like oral temperature, sitting blood pressure and radial pulse will be measured and recorded during subject check-in, prior to administration of dose, 1.00, 2.00, 6.00 and 12.00 hours after administration of dose and at check-out.
Clinical examination of the subjects will be done at the time of check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42 during the study and subjects will be monitored specifically for local adverse reactions (soreness, redness, swelling, pain, tenderness, induration and ecchymosis), systemic reactions (headache, muscle ache, fever [≥38 0C], nausea, vomiting, diarrhea, shivering, fatigue and malaise).
ECG will be recorded at the time of screening. Subjects will be questioned for well being at the time of clinical examinations and recording of vital signs.
Laboratory assessments: Hematology, serum chemistry, serology, Uric Acid and urine analysis will be done at the time of screening. Hematology, liver function and renal function tests will also be done on Day 21.
Urine test for drug of abuse and alcohol breath test will be performed at the time of check in during study period.
The data will be analyzed for demographics and safety parameters. Descriptive statistics will be provided for demographics, vitals and other safety assessments. Paired t test will be used to check the significance of pre and post data of the clinical laboratory parameters. Evaluation of safety and tolerability (adverse events, vital signs, and clinical laboratory parameters) will be done on the basis of clinical significant changes observed in the study |