| CTRI Number |
CTRI/2011/05/001730 [Registered on: 12/05/2011] Trial Registered Prospectively |
| Last Modified On: |
27/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine |
|
Scientific Title of Study
|
An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine (Split) of Changhchunchangsheng Life Sciences Ltd. In Pediatrics, Adolescent and Healthy Adults.” |
| Trial Acronym |
Influenza (Split) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEXUSCRO/INF/CT-III/4003/02-2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S V Kulkarni |
| Designation |
Consultant Physician |
| Affiliation |
Kulkarni Nursing Home |
| Address |
Kulkarni Nursing Home-144,
LBS Nagar, Khopoli,
Dist- Raigad Maharashtra, India-410203.
Raigarh
MAHARASHTRA
410203
India |
| Phone |
9325008557 |
| Fax |
|
| Email |
drcsvk61@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
CEO |
| Affiliation |
Nexus Clinical Research (India ) Ltd. |
| Address |
Anuj, Plot No 45, 1st Floor, Sector-13, Near D.Y.Patil Stadium,
Mumbai-Pune Highway, Nerul-(East), New Mumbai- 400 706.
Maharashtra- India.
Raigarh
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
022-27714204 |
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhatt |
| Designation |
CEO |
| Affiliation |
Nexus Clinical Research (India ) Ltd. |
| Address |
Anuj, Plot No 45, 1st Floor, Sector-13, Near D.Y.Patil Stadium,
Mumbai-Pune Highway, Nerul-(East), New Mumbai- 400 706.
Maharashtra- India.
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
022-27714204 |
| Email |
dramit.bhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| G. C. CHEMIE PHARMIE LTD. |
|
|
Primary Sponsor
|
| Name |
G C CHEMIE PHARMIE LTD |
| Address |
5/C, Shri Laxmi Industrial Estate, New Link Road, Andheri (w)
Mumbai-400053. India
|
| 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 S V Kulkarni |
Kulkarni Nursing Home |
Kulkarni Nursing Home-144,
LBS Nagar, Khopoli,
Dist- Raigad Maharashtra, India-410203.
Raigarh
MAHARASHTRA |
9325008557
drcsvk61@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Central Independant Ethics Comitee-Clinical Research (India) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers for achievement of titers for Influenza type A |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Influenza Vaccine |
Influenza Vaccine (Split) 0.25ml injection for single time use |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers who are able and are willing to comply with the protocol and have signed IEC/IRB approved “Informed Consent Forms (ICF)” voluntarily. Incase of pediatric and adolescent volunteers subject’s Legally Acceptable Representative have to sign ICF.”
Healthy male or non-pregnant, non-lactating female or pediatric or adolescent volunteers, ≥ 6 months of age or older on the day of inclusion and not older than 64 years.
Subjects with normal heath as determined by personal medical history, clinical
examination and laboratory examinations within the clinically acceptable normal range.
Volunteers who have not received influenza containing vaccines within five years.
Willing to give written informed consent and fulfill all study requirements.
Have a degree of understanding such that the subject can communicate intelligibly with the investigator and study coordinator.
Female volunteers of child bearing potential require a “Negative Urine Pregnancy Test” and must be willing to practice acceptable method of contraception or surgically sterile during the study and 6 weeks after the completion of study.
|
|
| ExclusionCriteria |
| Details |
Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol.
Self-reported history of severe adverse event to any influenza vaccine.
Acute febrile disease within the 72 hours, or axillary temperature 37.5°C the day of inclusion, prior to vaccination (37.0°C)
Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
Any vaccination within the 28 days preceding Visit 1 or scheduled between Visit 1 and Visit 4.
Receipt of blood or blood products within the 3 months preceding enrollment in the study.
Diabetes mellitus requiring pharmacological control.
Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for 2 weeks) or cancer therapy within the month preceding Visit 1 or ongoing
Immunoglobulin injection within the 3 months.
Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
Subject having received extracted pituitary hormones.
For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Current use of alcohol or recreational drugs that may interfere with the subjects ability to comply with trial procedures.
Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
Volunteers planning to leave the area of study site before completion of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of all adverse events
Common Solicited local and systemic reactions
Unsolicited AEs (including abnormal laboratory value)
SAEs during the study period
|
Visit 1
Day -7 to -1
(Screening )
Visit 2 Day 0
(Vaccination)
Visit 3 Day 28+7
(Post-Vaccination)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion/percentage of subjects achieving significant immune response against all three components of Influenza vaccine, 4 weeks after single dose of vaccination. |
Visit 1
Day -7 to -1
(Screening )
Visit 2 Day 0
(Vaccination)
Visit 3 Day 28+7
(Post-Vaccination)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/05/2011 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study
will be conducted after obtaining written informed consent from the subjects.
Incase of pediatrics and adolescent subjects; parents or Legally Acceptable
Representative (LAR) would sign the ICF. The subjects will undergo medical
screening during pre-study visit (Visit 1). Screening will include complete
clinical evaluation (medical history, general examination, record of height,
weight and vital signs).
Enrolled
adult subjects will receive a single dose of 0.5 ml of vaccine and pediatric
& adolescent subjects will receive a single dose of 0.25 ml of vaccine (Day
0) by intramuscular injection on the lateral aspect of arm in the deltoid
muscle. Blood sample will be collected for pre-immunization titers before
vaccination. Safety evaluation will be done for 3 hours on the vaccination day.
Subjects will then be followed up using standardized diary card for 28 days
post-vaccination for untoward AE/ADR and the same will be recorded in the CRF.
At visit 3 (day 28+7), blood sample will be collected post-immunization titers.
Clinical safety evaluation will also be done.
|