Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

November 30, 2016 updated by: Novartis Vaccines

Open-label, Uncontrolled Postmarketing Study to Evaluate Immunogenicity, Safety and Tolerability of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Elderly Subjects

This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety & tolerability of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, uncontrolled post-marketing study of the cell-derived A/H1N1 influenza HA vaccine. Subjects received 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75_halfMF59). All vaccination were administered IM in the deltoid muscle, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. Blood samples were collected at baseline (day1), 3 weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) assay. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e. Day 1 to Day 7 and Day 22 to Day 28). All AEs, SAEs, and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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, Japan
        • CPC Clinic, Medipolis Medical Research Institute

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

61 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Japanese aged over 60 years

Exclusion Criteria:

  • Any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease)
  • History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients
  • Administration of swine influenza (A/H1N1) vaccine prior to Day 1 or documented confirmed or suspected swine influenza disease
  • History of progressive or sever neurological disorders
  • Known or suspected impairment/alteration of immune function

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm:1
Biological: Emulsion, Cell Culture-based, influenza HA vaccine H1N1
Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)

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
Solicited reactions, 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

March 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 15, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V110_10

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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