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Trial record 85 of 112 for:    mf59

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

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ClinicalTrials.gov Identifier: NCT01819155
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : October 22, 2013
Sponsor:
Collaborators:
Institut de Recherche pour le Developpement
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
PATH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Adjuvanted seasonal trivalent inactivated influenza vaccine Biological: Seasonal trivalent inactivated influenza vaccine Biological: Saline (bacteriostatic 0.9% sodium chloride for injection) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal
Study Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: adjTIV
Children randomized to receive adjTIV
Biological: Adjuvanted seasonal trivalent inactivated influenza vaccine
Other Name: Fluad

Experimental: TIV
Children randomized to receive TIV
Biological: Seasonal trivalent inactivated influenza vaccine
Other Name: VaxiGrip

Placebo Comparator: Placebo
Children randomized to receive Placebo
Biological: Saline (bacteriostatic 0.9% sodium chloride for injection)



Primary Outcome Measures :
  1. Immunogenicity of adjTIV [ Time Frame: 28 days post-dose 2 ]
    serum hemagglutination-inhibition antibodies

  2. Immunogenicity of TIV [ Time Frame: 28 days post-dose 2 ]
    serum hemagglutination-inhibition antibodies


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: through three months post-dose 2 ]


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Ages Eligible for Study:   6 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01819155


Locations
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Senegal
Institut de Recherche pour le Développement
Niakhar, Senegal
Sponsors and Collaborators
PATH
Institut de Recherche pour le Developpement
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Aldiouma Diallo, MD Institut de Recherche pour le Developpement
Study Director: John C Victor, PhD, MPH PATH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01819155     History of Changes
Other Study ID Numbers: MF59-TIV-SEN-01
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: June 2013

Keywords provided by PATH:
influenza
influenza vaccine
immunogenicity
Africa
Senegal

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