Influenza Vaccine and Pneumococcal Vaccine

Korea University

Status and phase: Completed; Phase 4

Conditions: Influenza, Human; Pneumococcal Infections

Treatments: Biological: Influenza vaccination with PPV23; Biological: Influenza vaccination with PCV13

Study type: Interventional

Funder types: Other

Identifiers

NCT02582047

INFLUENZAPNEUMO

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 224 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Influenza vaccination with PPV23

Active Comparator group

Description:

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

Treatment:

Biological: Influenza vaccination with PPV23

Influenza vaccination with PCV13

Active Comparator group

Description:

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

Treatment:

Biological: Influenza vaccination with PCV13