Influenza Vaccine and Pneumococcal Vaccine

NCT02582047 | Completed Phase 4 DMC

• 1 other identifier: INFLUENZAPNEUMO
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza, Human; Pneumococcal Infections

Keywords

influenza vaccine; pneumococcal vaccine; simultaneous vaccination

Outcome Measures

Primary Outcomes (1)

• Seroconversion rates (A/H1N1, A/H3N2, and B)

  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

  Change from baseline titer at 4 weeks

Secondary Outcomes (2)

• Seroprotection rates (A/H1N1, A/H3N2, and B)

  Change from baseline titer at 4 weeks

• GMT folds (A/H1N1, A/H3N2, and B)

  Change from baseline titer at 4 weeks

Other Outcomes (1)

• Frequency and duration of local and systemic adverse events

  Monitor using a clinical diary for seven days after vaccination

Study Arms (2)

Influenza vaccination with PPV23

ACTIVE COMPARATOR

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

Biological: Influenza vaccination with PPV23

Influenza vaccination with PCV13

ACTIVE COMPARATOR

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

Biological: Influenza vaccination with PCV13

Interventions

Influenza vaccination with PPV23 BIOLOGICAL

GCflu and Pneumovax-23

Influenza vaccination with PPV23

Influenza vaccination with PCV13 BIOLOGICAL

GCflu and Prevenar-13

Influenza vaccination with PCV13

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults aged ≥65 years who signed the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (2)

Korea University Ansan Hospital

Ansan, Kyoungido, 15355, South Korea

Location

Hallym University Gangnam Sacred Hospital

Seoul, Seoul, 07441, South Korea

Location

MeSH Terms

Conditions

Influenza, Human; Pneumococcal Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hee Jin Cheong, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

KR (2)