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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Influenza, Human Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fluad alone

56 Fluad recipients: one vaccine injection administered on Day 0

Group Type ACTIVE_COMPARATOR

Fluad alone

Intervention Type BIOLOGICAL

Fluad

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

Group Type ACTIVE_COMPARATOR

Fluad and PPV23 on the different arms

Intervention Type BIOLOGICAL

Fluad and Prodiax

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

Group Type ACTIVE_COMPARATOR

Fluad and PPV23 on the same arm

Intervention Type BIOLOGICAL

Fluad and Prodiax

PPV23 alone

56 PPV23 recipients: one vaccine injection administered on Day 0

Group Type ACTIVE_COMPARATOR

PPV23 alone

Intervention Type BIOLOGICAL

Prodiax

Interventions

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Fluad alone

Fluad

Intervention Type BIOLOGICAL

Fluad and PPV23 on the different arms

Fluad and Prodiax

Intervention Type BIOLOGICAL

Fluad and PPV23 on the same arm

Fluad and Prodiax

Intervention Type BIOLOGICAL

PPV23 alone

Prodiax

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes