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Trial record 55 of 112 for:    mf59

MF59-adjuvanted Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

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ClinicalTrials.gov Identifier: NCT02225327
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : August 27, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Hee Jin Cheong, Korea University Guro Hospital

Brief Summary:
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.

Condition or disease Intervention/treatment Phase
Influenza, Human Pneumococcal Infections Biological: Fluad alone Biological: Fluad and PPV23 on the different arms Biological: Fluad and PPV23 on the same arm Biological: PPV23 alone Phase 4

Detailed Description:

During influenza season, concomitant influenza and pneumococcal vaccination would be an effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults. However, the immunogenicity and safety of concomitant vaccination need to be further investigated. There is data on immunogenicity and safety after concomitant administration of pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no interference was noted between two vaccines. However, there are no data for MF59 adjuvanted influenza vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response, so immunogenicity should be assessed for both vaccines injected in same arm versus different arms.

This study is intended to evaluate the immunogenicity and safety of concomitant MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years. Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm (group 3) or PPV23 alone (group 4).

Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA) will be used to compare the immunogenicity of each vaccine after single or concomitant vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four serotypes (5, 6B, 18C and 19A).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of MF59-adjuvanted Trivalent Influenza Vaccine (Fluad) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in the Elderly: Single Versus Concomitant Vaccination
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Fluad alone
56 Fluad recipients: one vaccine injection administered on Day 0
Biological: Fluad alone
Fluad

Active Comparator: Fluad and PPV23 on the different arms
56 concomitant Fluad-PPV23 recipients on the different arms: one dose of each vaccine administered on Day 0
Biological: Fluad and PPV23 on the different arms
Fluad and Prodiax

Active Comparator: Fluad and PPV23 on the same arm
56 concomitant Fluad-PPV23 recipients on the same arm with 1 inch distance: one dose of each vaccine administered on Day 0
Biological: Fluad and PPV23 on the same arm
Fluad and Prodiax

Active Comparator: PPV23 alone
56 PPV23 recipients: one vaccine injection administered on Day 0
Biological: PPV23 alone
Prodiax




Primary Outcome Measures :
  1. Seroconversion rates (A/H1N1, A/H3N2, and B) [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination) ]
    a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10


Secondary Outcome Measures :
  1. Seroprotection rates (A/H1N1, A/H3N2, and B) [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination). ]
    Percentage of subjects with a post-vaccination titer ≥1:40

  2. GMT folds (A/H1N1, A/H3N2, and B) [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination. ]
    GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer

  3. Opsonophagocytic assay (OPA) titers for four serotypes of PPV23 (serotypes 5, 6B, 18C and 19A) [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination). ]
    OPA geometric mean titers for four PPV23 serotypes with corresponding 2-sided 95% confidence intervals will be compared between groups receiving PPV23: MF59-adjuvanted TIV + PPV23 at different arm, MF59-adjuvanted TIV + PPV23 at same arm and PPV23 alone.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 65 years of age who are eligible for the study vaccines;
  • Who have given written informed consent at the time of enrollment);
  • Those who are available for all the visits scheduled in the study;
  • Subjects In good health as determined by medical history, physical examination and clinical judgment of the investigator

Exclusion Criteria:

  • History of egg allergy
  • History of influenza vaccination in previous 6 months
  • History of any pneumococcal vaccination
  • Documented S. pneumonia infection in the previous 5 years
  • Chemotherapy for malignancy within the past 30 days
  • High-dose systemic steroid (prednisone ≥0.5 mg/kg/day) in the past 30 days
  • Receipt of blood product within 6 months before enrollment
  • Significant acute or chronic infection within the previous 7 days or fever within the previous day
  • Any serious chronic or progressive disease
  • Any condition that might interfere with the study results.

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): NCT02225327


Sponsors and Collaborators
Korea University Guro Hospital
Novartis
Investigators
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Principal Investigator: Hee Jin Cheong, MD, PhD Korea University Guro Hospital
Study Director: Joon Young Song, MD, PhD Korea University Guro Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hee Jin Cheong, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT02225327     History of Changes
Other Study ID Numbers: FLUADPPV23
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Influenza, Human
Pneumococcal Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs