Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

November 30, 2016 updated by: Novartis Vaccines

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima pref., Japan
        • Osaka pref.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Japanese adults aged 20 to 60 years

Exclusion Criteria:

  • History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
  • Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
  • Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
  • History of progressive or severe neurological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Dose ranging
Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines
Other: Arm 2
Dose ranging
Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, vital signs, laboratory tests
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V110_05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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