Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years

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

1195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident that the likelihood of immune interference (in response to conjugated- or co-administered antigens) increases in proportional to the number of glyco-conjugates (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins: tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity, but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13 co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat reduced compared to the results with PCV13 alone.

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. PCV13 has limited co-administration information for adjuvanted influenza vaccine.

This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.

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Detailed Description

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This study is a multi-centered, randomized controlled clinical trial: Korea University Guro Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and Catholic University Medical College, St. Vincent's Hospital.

The primary objective is to evaluate the immunogenicity of Fluad after concomitant administration of Fluad and PCV13 in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of sero-conversion rate after Fluad vaccination: Fluad-PCV13 co-administration group versus Fluad alone group

The secondary objective is to evaluate the immunogenicity of PCV13 after concomitant administration in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of PCV13 when co-administered with Fluad compared with PCV13 alone.

This study is also designed to evaluate the safety of concomitant PCV13-Fluad administration in adults aged 60 years or more. All the participants will be followed for the duration of an expected average of 4 weeks after vaccination.

Conditions

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Influenza Streptococcus Pneumoniae

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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PCV13 and Fluad

437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0

Group Type ACTIVE_COMPARATOR

Fluad and Prevenar13

Intervention Type BIOLOGICAL

Fluad alone

437 Fluad recipients: one vaccine injection administered on Day 0

Group Type ACTIVE_COMPARATOR

Fluad

Intervention Type BIOLOGICAL

PCV13 alone

437 PCV13 recipients: one vaccine injection administered on Day 0

Group Type ACTIVE_COMPARATOR

Prevenar13

Intervention Type BIOLOGICAL

Interventions

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Fluad and Prevenar13

Intervention Type BIOLOGICAL

Fluad

Intervention Type BIOLOGICAL

Prevenar13

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged ≥60 years who signed the informed consent

Exclusion Criteria

* Previous pneumococcal vaccine recipients
* Egg allergy
* History of serious adverse event after vaccination,
* any acute disease or infection
* History of neurological symptoms or signs
* Impairment of immune function or immunosuppressant use
* Bleeding diathesis
* Fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes