A study to test the safety of a new H1N1 influenza vaccine in healthy volunteers

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/06/004707
• Date of registration: 26-06-2014
• Prospective Registration: Yes
• Primary sponsor: Cadila Pharmaceuticals Limited
• Public title: A study to test the safety of a new H1N1 influenza vaccine in healthy volunteers
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Immunogenicity and Safety of H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine
• Date of first enrolment: 01-07-2014
• Target sample size: 450
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8910
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Deepak Sawhney
• Affiliation: Cadila Pharmaceuticals Limited

• Name: Dr Deepak Sawhney
• Affiliation: Cadila Pharmaceuticals Limited

Key inclusion & exclusion criteria

Inclusion criteria: •Healthy volunteers of either sex between 18-64 years of age, inclusive



•Informed consent must be obtained from the volunteer prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.


Exclusion criteria: •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period



•Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection



•History of hypersensitivity to any component of inactivated influenza vaccines



•Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the administration of the study vaccine (inhaled & topical steroids are allowed)



•Use of systemic glucocorticoids within one month prior to randomization



•Any clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests



•Screening serum transaminase or alkaline phosphatase more than 3 times of ULN, creatinine and total bilirubin 1.5 times of ULN, Hgb 10 gm/dl, or BMI 28

ï?§

•Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen



•Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination



•Administration of immunoglobulin and/or any blood products within the three months preceding the administration of the study vaccine or during the study



•Acute illness of moderate or severe intensity at the time of enrollment, including any illness associated with fever ³100.5 0F



•Any congenital abnormalities, including hemglobinopathies, which could increase the risk of influenza complications



•History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome.



•Women who are found to have a positive urinary pregnancy test; pregnant or lactating history or physical examination, or planning to become pregnant or to discontinue contraceptive precautions within 60 days of enrollment in this study



•Volunteers found positive in drugs of abuse test



•Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months



•Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine: 0.5 ml Intramuscular injection of H1N1-09 influenza VLP vaccine (15µg HA of A/California/04/2009/H1N1) on Day 0 (SINGLE DOSE)
Control Intervention1: Placebo: 0.5 ml Intramuscular Injection on day 0 (SINGLE DOSE)

Primary Outcome(s)

immunogenicity of H1N1-09 influenza VLP vaccineTimepoint: Seroconversion rate (Time frame: 22 days post-vaccination)



Seroprotection rate (Time frame: 22 days post-vaccination)



Mean fold-rise (Time frame: 22 days post-vaccination)

Secondary Outcome(s)

safety and tolerability of H1N1-09 influenza VLP vaccineTimepoint: ï?§ Solicited adverse events (Time frame: 7 days post-vaccination)

ï?§ Unsolicited adverse events (Time frame: 22 days post-vaccination)

Secondary ID(s)

CRSC13001; Version-01, Protocol Amendment, Date 06/07/13

Source(s) of Monetary Support

Cadila Pharmaceuticals Limited

Ethics review

Status: Approved
Approval date: 16/05/2013
Contact:

Ethics Committee Apollo hospitals international limited Gandhinagar

Status: Approved
Approval date: 02/07/2013
Contact:

Ethics Committee Apollo hospitals Mysore

Status: Approved
Approval date: 07/10/2013
Contact:

Ethics comittee KEM hospital research centre Pune

Status: Approved
Approval date: 10/10/2013
Contact:

Ethics Committee Apollo hospitals international limited Hyderabad

Status: Approved
Approval date: 15/11/2013
Contact:

Ethics comittee on clinical trial Apollo Hospital Delhi

Status: Approved
Approval date: 16/11/2013
Contact:

Ethics comittee S P medical college and hospitals

Status: Approved
Approval date: 06/02/2014
Contact:

The Institutional Ethics committee B J Medical college & civil hospital ahmedabad

Status: Not Approved
Approval date:
Contact:

Ethics Committee Apollo hospitals Bhubaneswar

Status: Not Approved
Approval date:
Contact:

Ethics Committee Apollo hospitals Chennai

Status: Not Approved
Approval date:
Contact:

Ethics Committee Seth GS Medical College & KEM Hospital Mumbai

Status: Not Approved
Approval date:
Contact:

Institutite Ethics Committe AIIMS New Delhi