Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03540823
• Date of registration: 14/05/2018
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo General Hospital
• Public title: Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases
• Scientific title: Immunogenicity and Safety of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases
• Date of first enrolment: April 23, 2018
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03540823
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

• Name: Eduardo Borba, MD, PhD
• Affiliation: Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo São Paulo, Sao Paulo Brazil

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult and juvenile systemic lupus erythematosus (SLE) and juvenile SLE patients
according to the ACR classification criteria aged = 18 years for adults and aged = 9
and <18 years for the juvenile group

- Patients with primary Sjögren's Syndrome (SSp) (classification criteria of the
European Study Group on Diagnostic Criteria for Sjögren's Syndrome) aged = 18 years

Exclusion Criteria:

1. History of anaphylactic response to vaccine components or egg allergy

2. Moderate or severe acute febrile illness

3. Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating
disease.

4. History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2
weeks prior, influenza vaccine up to 6 months prior to study.

5. History of having received blood products up to 6 months prior to the study.

6. Individuals who do not agree to participate in the study and / or whose parents do not
agree to participate in the study.

7. Inpatients

8. Patients with severe conditions requiring hospitalization



Age minimum: 9 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Systemic Lupus

Intervention(s)

Biological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)

Primary Outcome(s)

Number of participants with seroprotection and seroconversion after Influenza vaccine [Time Frame: 30 days]

Secondary Outcome(s)

Number of participants with vaccine-related adverse events as assessed by CTCAE v4.0 [Time Frame: 30 days]

Secondary ID(s)

H3N2VaccineReumatoHC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors