Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years
NCT02215863
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Adult Trials: 18+ Years
- Adults aged ≥60 years who signed the informed consent
- 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)
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| Descriptive Information | |||||||
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| Brief Title ICMJE | Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ?60 Years | ||||||
| Official Title ICMJE | Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ?60 Years | ||||||
| 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. | ||||||
| Detailed Description | This study is a multi-centered, randomized controlled clinical trial: Korea University Guro Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and Catholic University Medical College, St. Vincent's Hospital. The primary objective is to evaluate the immunogenicity of Fluad after concomitant administration of Fluad and PCV13 in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of sero-conversion rate after Fluad vaccination: Fluad-PCV13 co-administration group versus Fluad alone group The secondary objective is to evaluate the immunogenicity of PCV13 after concomitant administration in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of PCV13 when co-administered with Fluad compared with PCV13 alone. This study is also designed to evaluate the safety of concomitant PCV13-Fluad administration in adults aged 60 years or more. All the participants will be followed for the duration of an expected average of 4 weeks after vaccination. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 1195 | ||||||
| Original Estimated Enrollment ICMJE | 1311 | ||||||
| Actual Study Completion Date ICMJE | March 2015 | ||||||
| Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02215863 | ||||||
| Other Study ID Numbers ICMJE | FLUPCV13 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Hee Jin Cheong, Korea University Guro Hospital | ||||||
| Study Sponsor ICMJE | Korea University Guro Hospital | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
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| PRS Account | Korea University Guro Hospital | ||||||
| Verification Date | March 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||