Study of immunity to flu vaccine.

Phase 3

• Registration Number: CTRI/2021/11/037859
• Lead Sponsor: Christian Medical College Vellore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adult volunteers who are between 21 to 60 years old, who are in good health (as

evaluated by physician by clinical history, examination, and investigations) who do not

meet the exclusion criteria will be recruited

Exclusion Criteria

(1) Baseline HAI titres > 1:20

(2) Pregnant women [pregnancy will be ascertained in women of reproductive age

group by menstrual history and urine testing if necessary]

(3) Any vaccination received in the last two weeks

(4) Volunteers who have been vaccinated against influenza in the last one year [as

ascertained from volunteerâ??s recall or documentation if available]

(5) Ongoing respiratory infections or respiratory infections in the last 1 month

(6) Antibiotic usage within the last 2 weeks

(7) Regular drug intake for any chronic illness or condition (including diabetes,

hypertension)

(8) Chronic respiratory conditions including COPD, asthma, ILD

(9) Egg allergy (as per influenza vaccines patient leaflet).

(10) Current regular (daily) smoker.

(11) A long-term health problem with heart disease, lung disease (including asthma),

kidney disease, neurologic disease, liver disease, metabolic disease (e.g.,

diabetes), or anaemia or another blood disorder (LAIV [Live Attenuated

Influenza Vaccine] contraindications list).

(12) Use of drugs for the treatment of rheumatoid arthritis, Crohnâ??s disease, or

psoriasis or anticancer drugs; or radiation treatments (LAIV contraindications

list).

(13) Live with or expect to have close contact with a person whose immune system is

severely compromised and who must be in protective isolation (e.g., an isolation

room of a bone marrow transplant unit)

(14) Hemoglobin < 10 g/dl

Study & Design

• Study Type: Interventional
• Study Design: Not specified