| CTRI Number |
CTRI/2016/04/006886 [Registered on: 28/04/2016] Trial Registered Prospectively |
| Last Modified On: |
14/09/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the safety and tolerability of Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (Adsorbed) in healthy adult male human subjects. |
|
Scientific Title of Study
|
An open-label, single-treatment, single-period, single dose, clinical phase 1 study to assess the safety and tolerability of Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (adsorbed) I.P. of M/S Cadila healthcare Ltd., India in healthy, adult, male, human subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PENTASD 1001 version 01 dated 11.09.2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KevinKumar Kansagra |
| Designation |
Principal Scientist |
| 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 382213, Gujarat, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
912717665555 |
| Fax |
912717665355 |
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KevinKumar Kansagra |
| Designation |
Principal Scientist |
| 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 382213, Gujarat, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
912717665555 |
| Fax |
912717665355 |
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KevinKumar Kansagra |
| Designation |
Principal Scientist |
| 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 382213, Gujarat, India
Ahmadabad
GUJARAT
382213
India |
| Phone |
912717665555 |
| Fax |
912717665355 |
| Email |
kevinkumarkansagra@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Limited. 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 |
Sigma Commerzone (1st Floor), Ambli- Bopal road, Satellite,
Ahmedabad – 380 015, Gujarat, India. Tel. No.: 079-2686 8900 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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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 |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382213,Gujarat, India
Ahmadabad
GUJARAT |
912717665555
912717665355
kevinkumarkansagra@zyduscadila.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee CIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA, as healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd. |
Dosage: 0.5 ml Intramuscular (I.M.) in upper arm.
Frequency: Single dose. |
| Comparator Agent |
NA, as single arm study. |
NA, as single arm study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
•Male subjects aged between 18 and 45 years (both inclusive).
•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 after previous dose of any Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccines or to any other component of the vaccine.
•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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd., India given intramuscularly in healthy adult male human subjects. |
Vital signs i.e Oral temperature,sitting blood
pressure and radial pulse:check-in, prior to
administration of dose, 1, 2, 6, and 12 hours after administration of dose, at checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42.
Respiratory Rate and Clinical examination: check-in, checkout (Day 01), Day 3,Day 7, Day 14, Day 21 and Day 42.
ECG:-screening.
Lab assessments:screening. Hematology,LFT and RFT tests on Day 21.
Check-in:Urine test for drug of abuse and alcohol breath test. |
|
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Secondary Outcome
|
|
|
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)
|
02/05/2016 |
| 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="2"
Days="0" |
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
|
The objective of the
study is to assess the safety and tolerability of Diphtheria, Tetanus,
Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate
vaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd., India given
intramuscularly in healthy adult male human subjects.
This is an open-label,
single-treatment, single-period, single dose, phase 1 vaccine study in healthy,
adult, male, human subjects.
|