Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

NCT02762851 | Unknown Phase 4 DMC

• 1 other identifier: RCT-IVVE 2015
• Study Type: interventional
• Target: 5,000
• Locations: 13 countries
• Sites: 13

Brief Summary

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

Conditions

Heart Failure; Influenza

Keywords

Influenza; Vaccine; Heart failure; Vascular

Outcome Measures

Primary Outcomes (1)

• Adverse cardiovascular event

  The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria.

  Six months

Secondary Outcomes (1)

• Cardiovascular (CV) death

  Six months

Study Arms (2)

Influenza vaccine

EXPERIMENTAL

Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine prior to the influenza season.

Drug: inactivated trivalent influenza vaccine

Placebo vaccine

PLACEBO COMPARATOR

Participants at high risk for adverse vascular events will be vaccinated with a 0.5 ml dose of sterile saline prior to the influenza season.

Other: Sterile saline

Interventions

Sterile saline OTHER

0.5 ml dose injected intramuscularly

Placebo vaccine

inactivated trivalent influenza vaccine DRUG

0.5 ml dose injected intramuscularly

Also known as: VAXIGRIP vaccine

Influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV

You may not qualify if:

• Anaphylactic reaction to a previous dose of TIV(trivalent influenza vaccine)
• Known IgE( Immunoglobulin E)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
• Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
• Anaphylactic reaction to neomycin
• Patients who have had influenza vaccine in two of the three previous years

Sponsors & Collaborators

• McMaster University: lead

Study Sites (13)

Douala General Hospital

Douala, Cameroon

TERMINATED

Fuwai Hospital

Beijing, Xicheng District, 100037, China

RECRUITING

Centre for Chronic Disease Control

New Delhi, India

RECRUITING

Aga Khan University

Nairobi, Kenya

RECRUITING

American University of Beirut Medical Center

Beirut, Lebanon

NOT YET RECRUITING

Maputo Central Hospital (Full Trial)

Maputo, Mozambique

RECRUITING

Bayero University and Aminu Kano Teaching Hospital

Kano, Nigeria

RECRUITING

University of Philippines

Manila, Emita, Philippines

RECRUITING

King Saud Univeristy

Riyadh, Saudi Arabia

RECRUITING

AlShaab Teaching Hospital

Khartoum, Sudan

TERMINATED

Mulago Hospital

Kampala, Uganda

RECRUITING

Sheikh Khalifa Medical City

Abu Dhabi, United Arab Emirates

RECRUITING

University of Zambia School of Medicine

Lusaka, Zambia

RECRUITING

Related Publications (47)

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• Loeb M, Roy A, Dokainish H, Dans A, Palileo-Villanueva LM, Karaye K, Zhu J, Liang Y, Goma F, Damasceno A, Alhabib KF, Yonga G, Mondo C, Almahmeed W, Al Mulla A, Thanabalan V, Rao-Melacini P, Grinvalds A, McCready T, Bangdiwala SI, Yusuf S; Influenza Vaccine to Prevent Adverse Vascular Events investigators. Influenza vaccine to reduce adverse vascular events in patients with heart failure: a multinational randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2022 Dec;10(12):e1835-e1844. doi: 10.1016/S2214-109X(22)00432-6.

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• Loeb M, Dokainish H, Dans A, Palileo-Villanueva LM, Roy A, Karaye K, Zhu J, Liang Y, Goma F, Damasceno A, AlHabib KF, Yonga G, Mondo C, Almahmeed W, Al Mulla A, Yusuf S; IVVE investigators. Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design. Am Heart J. 2019 Jun;212:36-44. doi: 10.1016/j.ahj.2019.02.009. Epub 2019 Mar 11.

  PMID: 30933856 DERIVED

MeSH Terms

Conditions

Heart Failure; Influenza, Human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Mark Loeb, MD, MSc.

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Loeb, MD, MSc.

CONTACT

905-525-9140; loebm@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); CN (1); SU (1); IN (1); SA (1); MO (1); NG (1); LE (1); PH (1); UG (1); CA (1); KE (1); AE (1)