Influenza Vaccine and Pneumococcal Vaccine

Phase 4

Completed

• Conditions: Pneumococcal Infections; Influenza, Human

• Registration Number: NCT02582047
• Lead Sponsor: Korea University Guro Hospital

Brief 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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seroconversion rates (A/H1N1, A/H3N2, and B)	Change from baseline titer at 4 weeks	Seroconversion: a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of \<1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10

Secondary Outcome Measures

Name	Time	Method
GMT folds (A/H1N1, A/H3N2, and B)	Change from baseline titer at 4 weeks	GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
Seroprotection rates (A/H1N1, A/H3N2, and B)	Change from baseline titer at 4 weeks	Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40

Trial Locations

Locations (2)

Korea University Ansan Hospital; 🇰🇷 Ansan, Kyoungido, Korea, Republic of

Hallym University Gangnam Sacred Hospital; 🇰🇷 Seoul, Korea, Republic of