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Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine

NCT03028116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-01-23

No results posted yet for this study

Summary

The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

influenza vaccine

A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).

BIOLOGICAL

Placebo

water for injection

Sponsors & Collaborators

  • Asfendiyarov Kazakh National Medical University

    collaborator OTHER

  • Research Institute of Influenza, Russia

    collaborator OTHER

  • Research Institute for Biological Safety Problems

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • Kazakhstan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028116 on ClinicalTrials.gov