An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine

Phase 3

Completed

• Registration Number: CTRI/2011/05/001730
• Lead Sponsor: G C CHEMIE PHARMIE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified