Influenza Vaccine and Pneumococcal 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

2012-10-31

Study Completion Date

2013-01-31

Brief Summary

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Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.

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Detailed Description

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During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.

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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Influenza vaccination with PPV23

concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine

Group Type ACTIVE_COMPARATOR

Influenza vaccination with PPV23

Intervention Type BIOLOGICAL

GCflu and Pneumovax-23

Influenza vaccination with PCV13

concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine

Group Type ACTIVE_COMPARATOR

Influenza vaccination with PCV13

Intervention Type BIOLOGICAL

GCflu and Prevenar-13

Interventions

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Influenza vaccination with PPV23

GCflu and Pneumovax-23

Intervention Type BIOLOGICAL

Influenza vaccination with PCV13

GCflu and Prevenar-13

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged ≥65 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
* History of Streptococcal pneumoniae infection within the previous 5 years

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes