Evaluation of heterosubtypic immune responses in older people

Phase 1

Completed

• Conditions: Topic: Inflammatory and Immune System, Generic Health Relevance and Cross Cutting Themes, Infection; Subtopic: Infection (all Subtopics), Inflammatory and Immune System (all Subtopics); Disease: Immunology and inflammation, Age and ageing; Infections and Infestations; Influenza vaccination

• Registration Number: ISRCTN70837239
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

1. Healthy subjects aged greater than or equal to 18 years of age, either sex
2. Subjects willing to receive vaccine in the trial
3. Able to complete informed consent and attend study visits

Exclusion Criteria

1. Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrolment and unwilling to refuse participation in another clinical study through the end of the study
2. Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days before Visit 1 or any visit where trial vaccination is planned
3. Subjects who experienced fever (defined as axillary temperature greater than or equal to 38.0°C) within 3 days prior to Visit 1
4. Subjects who are pregnant or breastfeeding
5. Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry
6. Subjects with any serious disease, such as:
6.1. Cancer
6.2. Autoimmune disease (including rheumatoid arthritis)
6.3. Progressive chronic pulmonary disease (stable controlled respiratory disease including asthma is allowed)
6.4. Acute or progressive hepatic disease
6.5. Acute or progressive renal disease
7. Subjects for whom elective surgery is planned during the study period
8. Subjects with bleeding diathesis
9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
10. Subjects with a history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
11. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
11.1. Receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy)
11.2. Receipt of immunostimulants
11.3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study
11.4. High risk for developing an immunocompromising disease
12. Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
13. Subjects with a history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives
14. Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Antibody titres (geometric mean titres) and mean fold rise after vaccination at visit 2, 3, 4 and 5<br>2. Proportion of subjects achieving seroconversion after vaccination at visits 2, 3, 4 and 5<br>3. Proportion of subjects achieving seroprotection (titre of =1:40) after vaccination at visits 2, 3, 4 and 5

Secondary Outcome Measures

Name	Time	Method
1. Cell mediated responses after vaccination at visit 1, 3 and 5<br>2. Frequency of solicited adverse reaction reported after vaccination at visits 2, 3, 4 and 5