Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years

NCT02215863

Last updated date
Study Location
Korea University Ansan Hospital
Ansan, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Influenza, Streptococcus Pneumoniae
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults aged ≥60 years who signed the informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Influenza, Streptococcus PneumoniaeImmunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years
NCT02215863
  1. Ansan,
  2. Seoul,
  3. Suwon,
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Influenza
  • Streptococcus Pneumoniae
Intervention  ICMJE
  • Biological: Fluad and Prevenar13
  • Biological: Fluad
  • Biological: Prevenar13
Study Arms  ICMJE
  • Active Comparator: PCV13 and Fluad
    437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0
    Intervention: Biological: Fluad and Prevenar13
  • Active Comparator: Fluad alone
    437 Fluad recipients: one vaccine injection administered on Day 0
    Intervention: Biological: Fluad
  • Active Comparator: PCV13 alone
    437 PCV13 recipients: one vaccine injection administered on Day 0
    Intervention: Biological: Prevenar13
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
 (submitted: March 31, 2015)
1195
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2014)
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:

  • Adults aged ?60 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 (prior to Visit 1)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Hee Jin Cheong, MD, PhDKorea University Guro Hospital
Principal Investigator:Joon Young Song, MD, PhDKorea University Guro Hospital
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