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

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ClinicalTrials.gov Identifier: NCT02215863
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hee Jin Cheong, Korea University Guro Hospital

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.


Condition or disease Intervention/treatment Phase
Influenza Streptococcus Pneumoniae Biological: Fluad and Prevenar13 Biological: Fluad Biological: Prevenar13 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: PCV13 and Fluad
437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0
Biological: Fluad and Prevenar13
Active Comparator: Fluad alone
437 Fluad recipients: one vaccine injection administered on Day 0
Biological: Fluad
Active Comparator: PCV13 alone
437 PCV13 recipients: one vaccine injection administered on Day 0
Biological: Prevenar13



Primary Outcome Measures :
  1. Seroconversion rates (A/H1N1, A/H3N2, and B) [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination) ]
    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 :
  1. Seroprotection rates and GMT folds (A/H1N1, A/H3N2, and B) [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination). ]
    • Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40
    • GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer

  2. Opsonophagocytic assay (OPA) titers for PCV13 [ Time Frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination). ]
    OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results


Other Outcome Measures:
  1. Frequency and duration of local and systemic adverse events [ Time Frame: All participants will be followed until 4 weeks after vaccination) ]
    The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215863


Locations
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Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Hallym University Gangnam Sacred Hospita
Seoul, Korea, Republic of
Catholic University Medical College, St. Vincent's Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Korea University Guro Hospital
Pfizer
Investigators
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Principal Investigator: Hee Jin Cheong, MD, PhD Korea University Guro Hospital
Principal Investigator: Joon Young Song, MD, PhD Korea University Guro Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hee Jin Cheong, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT02215863     History of Changes
Other Study ID Numbers: FLUPCV13
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Hee Jin Cheong, Korea University Guro Hospital:
Immunogenicity, Safety, MF59, Influenza vaccine, Pneumococcal vaccine
Additional relevant MeSH terms:
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Influenza, Human
Pneumonia
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs