Back to resultsInfluenza Vaccine and Pneumococcal Vaccine
Primary Purpose
Influenza, Human, Pneumococcal Infections
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Influenza vaccination with PPV23
Influenza vaccination with PCV13
Sponsored by
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring influenza vaccine, pneumococcal vaccine, simultaneous vaccination
Eligibility Criteria
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
Sites / Locations
- Korea University Ansan Hospital
- Hallym University Gangnam Sacred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Influenza vaccination with PPV23
Influenza vaccination with PCV13
Arm Description
concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine
concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Seroprotection rates (A/H1N1, A/H3N2, and B)
Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40
GMT folds (A/H1N1, A/H3N2, and B)
GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
Full Information
NCT ID
NCT02582047
First Posted
October 5, 2015
Last Updated
October 19, 2015
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02582047
Brief Title
Influenza Vaccine and Pneumococcal Vaccine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Pneumococcal Infections
Keywords
influenza vaccine, pneumococcal vaccine, simultaneous vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccination with PPV23
Arm Type
Active Comparator
Arm Description
concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine
Arm Title
Influenza vaccination with PCV13
Arm Type
Active Comparator
Arm Description
concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Influenza vaccination with PPV23
Intervention Description
GCflu and Pneumovax-23
Intervention Type
Biological
Intervention Name(s)
Influenza vaccination with PCV13
Intervention Description
GCflu and Prevenar-13
Primary Outcome Measure Information:
Title
Seroconversion rates (A/H1N1, A/H3N2, and B)
Description
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
Time Frame
Change from baseline titer at 4 weeks
Secondary Outcome Measure Information:
Title
Seroprotection rates (A/H1N1, A/H3N2, and B)
Description
Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40
Time Frame
Change from baseline titer at 4 weeks
Title
GMT folds (A/H1N1, A/H3N2, and B)
Description
GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
Time Frame
Change from baseline titer at 4 weeks
Other Pre-specified Outcome Measures:
Title
Frequency and duration of local and systemic adverse events
Description
the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time Frame
Monitor using a clinical diary for seven days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Jin Cheong, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Kyoungido
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Hallym University Gangnam Sacred Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Influenza Vaccine and Pneumococcal Vaccine
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