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

March 31, 2015 updated by: Hee Jin Cheong, Korea University Guro Hospital

Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1195

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Korea University Ansan Hospital
      • Seoul, Korea, Republic of
        • Hallym University Gangnam Sacred Hospita
      • Suwon, Korea, Republic of
        • Catholic University Medical College, St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
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
Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All participants will be followed until 4 weeks after vaccination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Hee Jin Cheong, MD, PhD, Korea University Guro Hospital
  • Principal Investigator: Joon Young Song, MD, PhD, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUPCV13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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