| CTRI Number |
CTRI/2017/07/009034 [Registered on: 12/07/2017] Trial Registered Prospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety of Diptheria, Tetanus, acellular Pertussis, Poliomyelitis and Haemophilus influenzae type b vaccine in healthy adults |
|
Scientific Title of Study
|
A phase I, prospective, open label clinical study to assess the safety and tolerability of DTaP-IPV+Hib vaccine manufactured by Serum Institute of India Pvt. Ltd. in healthy adult volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SII-aPENTA/IN-01 Version no 01 dated 29 July 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Marthak |
| Designation |
Director and Head, Global Clinical Development |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda Therapeutic Research Ltd
Lambda House, Plot No. 38, Survey no 388,
Near Silver Oak Club, S G Highway, Gota,
Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
kiranmarthak@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitt Sharma |
| Designation |
Additional Medical Director |
| Affiliation |
Serum Institute Of India Ltd |
| Address |
Serum Institute of India Pvt. Ltd
212/2, Hadapsar
Soli Poonawalla Road, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
hittsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitt Sharma |
| Designation |
Additional Medical Director |
| Affiliation |
Serum Institute Of India Ltd |
| Address |
Serum Institute of India Pvt. Ltd
212/2, Hadapsar
Soli Poonawalla Road, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
hittsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Pvt Ltd
212/ 2, Hadapsar, Off Soli Poonawalla Road, Pune 411028, India |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Pvt Ltd |
| Address |
212/ 2 Hadapsar
Soli Poonawalla Road Pune |
| 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 Kiran Marthak |
Lambda Therapeutic Research Ltd |
Clinical Pharmacology and Medical Affairs, Phase I, Phase I Unit, Lambda House, Plot No. 38, Survey no. 388,
Near Silver Oak Club,
S G Highway, Gota,
Ahmedabad
Ahmadabad
GUJARAT |
079-40202020
kiranmarthak@lambda-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Care Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DTaPIPV and Hib vaccine |
Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus influenzae type b vaccine |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult human subjects between 18 and 45 years of age (both
inclusive) .
2. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive),
calculated as weight in kg/height in m2 with minimum of 50 kg weight.
3. Healthy subjects as established by personal medical history, physical
examination, laboratory investigation during screening and as per the
clinical judgment of the Investigator.
4. Sexually active participants to be using an effective method of
contraception (i.e. intrauterine device or hormonal contraception or
condom, diaphragm, cervical cap).
5. Subject‟s willingness and ability to comply with the requirements of the
protocol.
6. Subject willing to sign a written informed consent. |
|
| ExclusionCriteria |
| Details |
1. History of any allergic diseases or history of a serious reaction to any prior
vaccination or known hypersensitivity to any component of the study
vaccines.
2. History of anaphylactic shock.
3. History of previous vaccination against diphtheria, tetanus, pertussis, polio
or Hib with either the trial vaccine or another vaccine (except Tetanusprone
wound management for adults) in the past 5 years.
4. History of diphtheria, tetanus, pertussis, polio or Haemophilus influenzae
type B infection (confirmed either clinically, serologically or
microbiologically).
5. History of major congenital defects or illness that require medical therapy,
as determined by medical history or clinical assessment.
6. History of any cancer, leukemia, HIV infection, organ transplant or any
other immune system disease.
7. History or presence of any disease or condition which might compromise
the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous,
cardiovascular, immunological, dermatological, gastrointestinal or any
other body system.
8. Ingestion or Use of any medication (including herbal remedies) at any
time in 14 days or immune-modifying drugs in last 3 months prior to IP
administration or planned at any time during the study. In any such case
subject selection will be at the discretion of the Principal Investigator.
9. Any history or presence of asthma (including aspirin induced asthma) or
nasal polyp or NSAIDs induced urticaria.
10. Smokers, who smoke 10 or more than 10 cigarettes/beedis per day or
inability to abstain from smoking during the study.
11. History of significant alcoholism in the past one year.
12. The presence of clinically significant abnormal laboratory values during
screening.
13. Abnormal ECG and chest X-ray.
14. Use of any recreational drugs or history of drug addiction or testing
positive in pre study drug scans.
15. History or presence of psychiatric disorder
16. A positive hepatitis screen including hepatitis B surface antigen and/or
HCV antibodies.
17. A positive test result for HIV antibody.
18. Female participant who is pregnant or breast-feeding, or wanting to fall
pregnant during trial participation.
19. Investigator, site personnel directly affiliated with this study and their
immediate families. Immediate family is defined as a spouse, parent, child
or sibling, whether biological or legally adopted.
20. Acute illness (moderate or severe) and/or fever (oral temperature ≥38°C)
at the time of vaccination or during the 7 days prior to the vaccination.
21. History of receipt a blood transfusion or other blood products in the year
prior to screening.
22. Use of any investigational or non-registered drug within 30 days preceding
the study vaccine administration, or planned use during the study period.
23. History of administration of any vaccine within 30 days prior to
administration of study vaccine or planned during the course of study
participation.
24. Participation in a drug research study within past 3 months or planned
participation during the study.
25. Participant has any plans to permanently relocate from the area prior to the
completion of the study or to leave for an extended period of time when
study visits would need to be scheduled.
26. Any other condition which in the opinion of the investigator will
jeopardize the safety of the subject due to participation 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 DTaP IPV Hib vaccine |
To assess the safety and tolerability of DTaP IPV Hib vaccine, on day 7 and 30 post vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/07/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/11/2017 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a phase I, prospective and open label clinical trial to assess safety and tolerability of SIIPL‟s DTaPIPV+Hib vaccine in 24 healthy adult volunteers aged 18-45 years. Active follow up for vaccine reactogenicity over the 7 day period after vaccination will be conducted in all subjects. In addition, all the subjects will be followed up for unsolicited AEs and SAEs over the period between enrollment and 30 days after vaccination. |