PDF of Trial CTRI Website URL

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 12:13:26 GMT)

CTRI Number CTRI/2010/091/000032 [Registered on: 30/04/2010] - Last Modified On 12/12/2014 Post Graduate Thesis No Type of Trial Interventional Type of Study Vaccine Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study A phase II/III clinical study to evaluate the immunogenicity and safety of three formulations of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults. Scientific Title of A randomized, double blind, comparative, phase II/III study to evaluate the immunogenicity and Study safety of three formulations (15mcg without adjuvant and 7.5mcg with adjuvant and 3.75mcg with adjuvant) of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults. Secondary IDs if Any Secondary ID Identifier PBL/CR/2009/11/CT Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Arani Chatterjee Trial Coordinator (multi-center study) Designation Sr VP Affiliation Panacea Biotec LTD Address B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi DELHI 110044 India Phone 1141679000 Fax 01141578085 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Arani Chatterjee Query) Designation Sr VP Affiliation Panacea Biotec Limited Address B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi DELHI 110044 India Phone 11416790002510 Fax 01141578085 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Arani Chatterjee Designation Sr VP Affiliation Panacea Biotec Ltd Address B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi DELHI 110044 India Phone 1141679000 Fax 01141578085

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Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Panacea Biotec Limited Primary Sponsor Primary Sponsor Details Name Panacea Biotec Limited Address B-1 Extn/G-3, Mohan Co-op. Ind. Estate, Mathura Road, New Delhi-110044 India Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr. Amit Upadhyay Auriga Research ,- 09999735215 Ltd,Delhi Not Applicable N/A Dr. Arjun Lal Kakrani D. Y Patil Medical ,- 09823972424 college, Pune Not Applicable N/A [email protected] Dr Salil Bhargava Gyanpushp Research Surabhi, 76, Dhar 09827060404 center for chest & Kothi,indore Allergy Diseases Indore [email protected] MADHYA PRADESH m Dr Prakash V Joshi Sant Dnyaneshwar ,- 09822874373 Medical Education Not Applicable Research Centre,Pune N/A [email protected] m Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee of Approved 11/04/2010 No Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Indore Hippocrates IEC, Uttam Approved 18/04/2010 No Nagar, New Delhi Institutional Ethics Approved 17/04/2010 No Committee, Dr DY Patil Medical College, Pune Sant Dnyaneshwar Approved 14/04/2010 No Medical Education Research Centre,Pune Regulatory Clearance Status Date Status from DCGI Approved/Obtained 14/01/2010 Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers H1N1 vaccine in Healthy adults. Intervention / Type Name Details Comparator Agent Intervention Two Intramuscular injections 0.5 ml of either of the three with either of the three formulations will be formulations [15 mcg administered 21 days apart.

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(unadjuvanted), 7.5 mcg (adjuvanted) and 3.75 mcg (adjuvanted)] of H1N1 vaccines Comparator Agent NIL No control intervention in the study Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1. Healthy male or female volunteers aged 18 years and above.
2. Subjects with normal health as determined by personal medical history, clinical examination and past laboratory examinations (within the clinically acceptable normal range) done during screening.
3. Subject willing to give written informed consent and fulfill all study requirements.
4. If female subjects and;
? Of child bearing potential but practicing acceptable method of contraception or surgically sterile.
? Acceptable methods of contraception are:
? Intra-uterine contraceptive device without hormone release system (placed at least 4weeks prior to study drug administration.
? Effective method of barrier contraception like condom or diaphragm with spermicidal gel/foam/film/cream/suppository
Exclusion Criteria Exclusion Criteria Details 1. Cases, cured cases and contact of influenza A (H1N1) virus 2. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, thiomersal, squalene. 3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids 5. Uncontrolled Diabetes mellitus (type I or II), 6. History of thyroidectomy or thyroid disease that required medication within the past 12 months 7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws 8. Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study 9. Subjects with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy .Seizure disorder other than: a. Seizures secondary to alcohol withdrawal more than 3 years ago, or b. A singular seizure not requiring treatment within the last 3 years 10. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen 11. Guillain-Barre Syndrome 12. History of any blood/ blood derived products or seasonal influenza vaccine administration within 3 months before the dosing 13. Administration of any other investigational research agents as well as any live attenuated vaccine within 30 days before the dosing 14. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing 15. Currently receiving anti-TB prophylaxis or therapy

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16. Oral temperature 37.0 centigrade at the time of dosing 17. Psychiatric condition that precludes compliance with the protocol: a. Past or present psychoses b. Past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years c. Disorder requiring lithium d. Suicidal ideation occurring within five years prior to enrollment 18. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteers ability to give informed consent 19. Evidence of acute illness within past 7 days prior to enrollment requiring systemic antibiotic or antiviral therapy 20. Subjects with pre-existing autoimmune illnesses like rheumatoid arthritis, lupus, multiple sclerosis etc. 21. Presence of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/ narrowing of airways), gastrointestinal, endocrine, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment that in the opinion of the investigator, are likely to interfere with study outcome or study subject safety. 22. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressant?s or other immune-modifying drugs in the past or any time during the study or intake of any other medications which may interfere with study volunteers self assessing ability / safety. 23. Significant alcoholism or drug abuse which may interfere with study volunteers self assessing ability / safety. 24. Subjects who in the opinion of the investigator are not suitable for inclusion 25. Subjects who have participated in other trials 3 months prior to enrollment 26. Planned participation in another clinical trial during the trial period 27. Subjects planning to leave the area of study site before completion of the study. 28. Positive pregnancy test 29. Presence of tattoos that cover or partially cover the deltoid region arm.

Method of Generating Permuted block randomization, fixed Random Sequence Method of Pre-numbered or coded identical Containers Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Immunogenicity Endpoint 21 days after each vaccine dose The proportion of subjects achieving HI antibody titers ?1:40 and seroconversion rates for subjects in each dose will be evaluated. Secondary Outcome Outcome Timepoints Safety Endpoint Upto 42 days after last vaccination ? Incidence of solicited adverse events 3 hours and during the 7 days after each vaccine dose in the three treatment groups ? Incidence of unsolicited adverse events upto 42 days after each vaccine dose. ? Incidence of SAE during the entire study period

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in the three treatment groups

Target Sample Size Total Sample Size=360 Sample Size from India=360 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 2/ Phase 3 Date of First No Date Specified Enrollment (India) Date of First 01/05/2010 Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=5 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Brief Summary The primary objective of the trial is to evaluate the immunogenicity of the trial vaccine in the study age group whereas the secondary objective is to evaluate the safety of the vaccines.Subjects fulfilling the selection criteria will be randomized in three groups of 120 subjects each. Subjects in each group will receive two doses of one of the three test vaccines. Subjects will be administered with the study vaccines on Day 0 & Day 21and will be followed up to Day 63. A blood sample will be collected on Day 0 (Pre-dose), Day 21 (Predose) and Day 42 for immunogenicity parameters (HI antibodies).Urine pregnancy test will be conducted on Day0 and day 21 for female subjects. Female subjects will be advised to practice contraception during and 3 months after study. Adverse reactions (solicited) will be observed (up to 3 hrs) and for 7 days (Day 0-7) after each dose. A subject diary card will be issued for recording the same. Adverse reactions will also be monitored upto 42 days following each vaccination. The subject?s will be advised to report to the investigator in case of any new symptom during the course of the trial. Serious adverse events will be monitored for the entire study duration.

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