Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years
1 other identifier
interventional
1,195
1 country
3
Brief Summary
Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident that the likelihood of immune interference (in response to conjugated- or co-administered antigens) increases in proportional to the number of glyco-conjugates (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins: tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity, but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13 co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat reduced compared to the results with PCV13 alone. Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. PCV13 has limited co-administration information for adjuvanted influenza vaccine. This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 1, 2015
March 1, 2015
6 months
August 11, 2014
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rates (A/H1N1, A/H3N2, and B)
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
Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)
Secondary Outcomes (2)
Seroprotection rates and GMT folds (A/H1N1, A/H3N2, and B)
Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
Opsonophagocytic assay (OPA) titers for PCV13
Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
Other Outcomes (1)
Frequency and duration of local and systemic adverse events
All participants will be followed until 4 weeks after vaccination)
Study Arms (3)
PCV13 and Fluad
ACTIVE COMPARATOR437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0
Fluad alone
ACTIVE COMPARATOR437 Fluad recipients: one vaccine injection administered on Day 0
PCV13 alone
ACTIVE COMPARATOR437 PCV13 recipients: one vaccine injection administered on Day 0
Interventions
Eligibility Criteria
You may qualify if:
- Adults aged ≥60 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 (prior to Visit 1)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea University Guro Hospitallead
- Pfizercollaborator
Study Sites (3)
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Gangnam Sacred Hospita
Seoul, South Korea
Catholic University Medical College, St. Vincent's Hospital
Suwon, South Korea
Related Publications (1)
Song JY, Cheong HJ, Hyun HJ, Seo YB, Lee J, Wie SH, Choi MJ, Choi WS, Noh JY, Yun JW, Yun JG, Kim WJ. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults. Vaccine. 2017 Jan 5;35(2):313-320. doi: 10.1016/j.vaccine.2016.11.047. Epub 2016 Dec 3.
PMID: 27919632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee Jin Cheong, MD, PhD
Korea University Guro Hospital
- PRINCIPAL INVESTIGATOR
Joon Young Song, MD, PhD
Korea University Guro Hospital
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
August 11, 2014
First Posted
August 13, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 1, 2015
Record last verified: 2015-03