We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 156 for:    Recruiting, Not yet recruiting, Available Studies | "Influenza, Human"
Previous Study | Return to List | Next Study

Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3 (IVACFLUS-0203)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03095599
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a phase 2/3, double-blind, placebo-controlled trial of 888 adults, ages 18 to 60 years old randomized to receive vaccine or placebo in a 5:1 vaccine:placebo randomization.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: IVACFLU-S Other: Placebo Phase 2 Phase 3

Detailed Description:

This is a phase 2/3, double-blind, placebo-controlled trial of 888 adults, ages 18 to 60 years old randomized to receive vaccine or placebo in a 5:1 vaccine:placebo randomization. Phase 2 will be conducted at 1 site of Long An (252 subjects). Following a determination of safety of vaccine in phase 2 study by Protocol Safety Review Team (PSRT) review and with approval from Vietnam Ministry of Health (MOH), Phase 3 enrollment will commence at 2 sites, Long An (252 subjects) and Dong Nai (384 subjects).

Safety will be assessed in all Phase 2 and 3 participants through Day 91. Safety data till Day 8 post-vaccination from the phase 2 study will be presented to Protocol Safety Review Team (PSRT) for evaluation and an interim report will be filed with local institutional review board (IRB) and MOH. Immunogenicity will be assessed only in Phase 3 participants. Blood samples will be collected in a subset of 252 individuals randomized at one of the study sites to get evaluable samples from at least 200 vaccine recipients (100 each from both age groups) and 40 placebo recipients (20 each from both age groups) 21 days after vaccination.

Approximate participant distribution based on age, study arm and study will be as follows:

Age group: Phase 2 will have 2 age groups (18-45; 46-60). In each age group, 105 subjects will receive IVACFLU-S and 21 subjects will receive Placebo, resulting in 126 subjects total per age group. Phase 3 will have 2 age groups (18-45; 46-60). In each age group, 265 subjects will receive IVACFLU-S and 53 subjects will receive Placebo, resulting in 318 subjects total per age group.

Hypotheses:

Safety:

A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) will be safe and well tolerated in adults 18 to 60 years of age.

Immunogenicity:

A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) will induce immune responses to each of the three vaccine antigens to meet one or both age group specific Vietnam Ministry of Health (MOH) licensure requirements.

The criteria for 18-45 year olds for HAI seroprotection (HAI ≥1:40) is ≥70%; for 46-60 year olds is ≥60%.

The criteria for seroconversion for 18-45 year olds is ≥40%; for 46-60 year olds is ≥30%.

The criteria for HAI GMT increase for 18-45 year olds is ≥2.5 times; for 46-60 year olds is

≥2.0 times.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 888 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2/3 Double Blinded, Randomized, Placebo-Controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced by IVAC
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vaccine

IVACFLU-S

IVACFLU-S is seasonal inactivated, split virion, trivalent influenza vaccine (A/H3N2, A/H1N1, and B), produced in GCP facility by IVAC uses embryonated chicken eggs. This vaccine is purified by sucrose gradient ultracentrifugation (Alfa Wassermann, West Caldwell, NJ), and inactivated with formaldehyde. It contains

  • NYMC X-179A (A/California/7/2009) (H1N1) - 15μg HA
  • NYMC X-263B (A/HongKong/4801/2014) (H3N2) - 15μg HA
  • NYMC BX-35 (B/Brisbane/60/2008) (B) - 15μg HA per 0.5 mL dose of vaccine.
Biological: IVACFLU-S
Trivalent inactivated split virion influenza vaccine
Placebo Comparator: Placebo
PBS with pH 7.2; 0.5 ml/per dose
Other: Placebo
PBS


Outcome Measures

Primary Outcome Measures :
  1. Number of AEs [ Time Frame: 90 days ]
    Number of AEs per arm

  2. Immunogenicity [ Time Frame: 21 days post immunization ]
    HAI


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy or in stable health
  • Literate
  • If woman who can become pregnant: willing to use reliable contraceptive until 3 weeks after injection.
  • Not pregnant or breastfeeding

Exclusion Criteria:

  • History of hypersensitivity following any vaccination
  • Known or suspected congenital or acquired immunodeficiency
  • Known tuberculosis or symptoms of active tuberculosis (self report)
  • Known allergies to the components of the vaccine
  • History of Gullain-Barre
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095599


Contacts
Contact: Phan Cong Hung, MD +084 0935288287 conghungpasteur@gmail.com

Locations
Vietnam
Pasteur Institute, Ho Chi Minh City Recruiting
Ho Chi Minh City, Vietnam
Contact: Phan Cong Hung, MD    0935288287      
Contact: Hoang Anh Thang, MD    0903224407      
Sponsors and Collaborators
Institute of Vaccines and Medical Biologicals, Vietnam
Pasteur Institute, Ho Chi Minh City
PATH
Quintiles, Inc.
World Health Organization
Investigators
Principal Investigator: Phan Cong Hung, MD Pasteur Institute, Ho Chi Minh City
More Information

Responsible Party: Institute of Vaccines and Medical Biologicals, Vietnam
ClinicalTrials.gov Identifier: NCT03095599     History of Changes
Other Study ID Numbers: IVACFLU-S 0203
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Vaccines and Medical Biologicals, Vietnam:
Influenza
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs