NCT02582047

Influenza Vaccine and Pneumococcal Vaccine

Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Influenza, Human
• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccination with PPV23	GCflu and Pneumovax-23
BIOLOGICAL	Influenza vaccination with PCV13	GCflu and Prevenar-13

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2015-10-21
• Last updated: 2015-10-21

Locations

2 sites across 1 country: South Korea