Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa

October 18, 2013 updated by: PATH

Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal

This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months through 71 months in the town of Niakhar, Senegal. A total of 300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo. Each child will receive two doses of one of the three study vaccines, with each dose given 28 days apart. Each child will be followed closely for safety after each dose for the period from one month post-dose two to 3 months post-dose two. For determination of immune response to vaccination or background influenza infection, 3 mL of blood will be obtained at three time points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days post-dose two. Serum anti-influenza antibodies produced against virus strains contained in the vaccine will be detected using hemagglutination inhibition assay.

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Phase 2

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

  • Senegal
      • Niakhar, Senegal
        • Institut de Recherche pour le Developpement

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

6 months to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
  • Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
  • Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.

Exclusion Criteria:

  • Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
  • Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
  • Previous receipt of any influenza vaccine.
  • Hypersensitivity after previous administration of any vaccine.
  • Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of <37.5°C, are not reason for exclusion or postponing study vaccination.)
  • Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adjTIV
Children randomized to receive adjTIV
Biological: Adjuvanted seasonal trivalent inactivated influenza vaccine
Other Names:
  • Fluad
Experimental: TIV
Children randomized to receive TIV
Biological: Seasonal trivalent inactivated influenza vaccine
Other Names:
  • VaxiGrip
Placebo Comparator: Placebo
Children randomized to receive Placebo
Biological: Saline (bacteriostatic 0.9% sodium chloride for injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of adjTIV
Time Frame: 28 days post-dose 2
serum hemagglutination-inhibition antibodies
28 days post-dose 2
Immunogenicity of TIV
Time Frame: 28 days post-dose 2
serum hemagglutination-inhibition antibodies
28 days post-dose 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: through three months post-dose 2
through three months post-dose 2

Collaborators and Investigators

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

Sponsor

PATH

Collaborators

Centers for Disease Control and Prevention
Institut de Recherche pour le Developpement

Investigators

  • Study Director: John C Victor, PhD, MPH, PATH
  • Principal Investigator: Aldiouma Diallo, MD, Institut de Recherche pour le Developpement

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

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF59-TIV-SEN-01

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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