Tropical Influenza Control Strategies for the Elderly

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02655874
• Date of registration: 12/01/2016
• Prospective Registration: Yes
• Primary sponsor: Tan Tock Seng Hospital
• Public title: Tropical Influenza Control Strategies for the Elderly TROPICS1
• Scientific title: A Single-centre, Randomised, Observer-blind, Active Comparator-controlled, Superiority Trial of the Immune Response to Six-monthly Versus Annual Standard Dose Inactivated Trivalent Influenza Vaccination in the Elderly
• Date of first enrolment: May 2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02655874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Singapore

Contacts

• Name: Barnaby Young
• Affiliation: Tan Tock Seng Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =65 years on the day of inclusion

2. No influenza vaccination in the previous 10 months

3. No tetanus, diphtheria or pertussis vaccine in the previous 1 year

4. No virologically confirmed influenza infection in the previous 10 months

5. Able to provide written informed consent

6. Able to attend all scheduled visits and comply with all trial procedures

Exclusion Criteria:

1. Participation in the 4 weeks preceding the first trial vaccination or participation
during the present trial period in another trial investigating a vaccine, drug,
medical device, or medical procedure

2. History of a life threatening reaction to the vaccine used in the trial, or to a
vaccine containing any of the same substances

3. Known systemic hypersensitivity to any of the vaccine components, including:

- Egg protein (eggs or egg products)

- Chicken products

- Formaldehyde

- Neomycin or kanamycin

- Octoxinol 9 (Triton X-100)

- Cetyltrimethylammonium bromide (CTAB)

4. History of Guillain-Barré syndrome (GBS) within 6 weeks following previous influenza
vaccination

5. Acute respiratory infection on the day of enrolment

6. Moderate or severe acute illness/infection (according to investigator judgement) on
the day of vaccination, or febrile illness (temperature = 37.5°C). A prospective
subject should not be included in the study until the condition has resolved or the
febrile event has subsided.

7. Self-reported thrombocytopenia, contraindicating Intramuscular vaccination

8. Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding six months; or long-term systemic corticosteroid therapy
(prednisolone = 7.5mg/day or equivalent for more than 2 consecutive weeks within the
past 3 months)

9. Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion

10. Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily

11. Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures in the opinion of the Investigator



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Influenza, Human

Intervention(s)

Biological: Tetanus-diphtheria-pertussis vaccine

Biological: Influenza vaccine

Primary Outcome(s)

Seroprotection (Proportion of subjects with HI titre =1:40 (1/dil) at day 208 post-primary vaccination for each of the influenza strains present in the administered influenza vaccine) [Time Frame: Day 208 post-vaccination]

Secondary Outcome(s)

Seroconversion (Proportion of subjects achieving seroconversion after vaccination for each of the influenza strains present in the administered influenza vaccine) [Time Frame: Day 208 to 360 post-vaccination]

Solicited and unsolicited adverse events [Time Frame: Day 1 to 7 and day 180 to 187]

Serious adverse events [Time Frame: Day 1 to 28, and day 180 to 208]

Geometric mean titres [Time Frame: Day 208 to 360 post-vaccination]

Influenza infection [Time Frame: Day 208 to 360 post-vaccination]

Micro-neutralization titres [Time Frame: Day 208 to 360 post-vaccination]

Seroprotection (Proportion of subjects with HI titre =1:40 (1/dil) at day 208 post-primary vaccination for each of the influenza strains present in the administered influenza vaccine) [Time Frame: Day 360 post-vaccination]

Healthcare utilization [Time Frame: Day 180 to 360 post-vaccination]

Geometric mean ratio [Time Frame: Day 208 to 360 post-vaccination]

Influenza-like illness [Time Frame: Day 208 to 360 post-vaccination]

Secondary ID(s)

2015/01047

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Healthcare Group, Singapore