MF59-adjuvanted Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

NCT02225327 | Completed Phase 4 DMC

• 1 other identifier: FLUADPPV23
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.

Conditions

Influenza, Human; Pneumococcal Infections

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 (3)

• Seroprotection rates (A/H1N1, A/H3N2, and B)

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

• 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 four serotypes of PPV23 (serotypes 5, 6B, 18C and 19A)

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

Study Arms (4)

Fluad alone

ACTIVE COMPARATOR

56 Fluad recipients: one vaccine injection administered on Day 0

Biological: Fluad alone

Fluad and PPV23 on the different arms

ACTIVE COMPARATOR

56 concomitant Fluad-PPV23 recipients on the different arms: one dose of each vaccine administered on Day 0

Biological: Fluad and PPV23 on the different arms

Fluad and PPV23 on the same arm

ACTIVE COMPARATOR

56 concomitant Fluad-PPV23 recipients on the same arm with 1 inch distance: one dose of each vaccine administered on Day 0

Biological: Fluad and PPV23 on the same arm

PPV23 alone

ACTIVE COMPARATOR

56 PPV23 recipients: one vaccine injection administered on Day 0

Biological: PPV23 alone

Interventions

Fluad alone BIOLOGICAL

Fluad

Fluad alone

Fluad and PPV23 on the different arms BIOLOGICAL

Fluad and Prodiax

Fluad and PPV23 on the different arms

Fluad and PPV23 on the same arm BIOLOGICAL

Fluad and Prodiax

Fluad and PPV23 on the same arm

PPV23 alone BIOLOGICAL

Prodiax

PPV23 alone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• At least 65 years of age who are eligible for the study vaccines;
• Who have given written informed consent at the time of enrollment);
• Those who are available for all the visits scheduled in the study;
• Subjects In good health as determined by medical history, physical examination and clinical judgment of the investigator

You may not qualify if:

• History of egg allergy
• History of influenza vaccination in previous 6 months
• History of any pneumococcal vaccination
• Documented S. pneumonia infection in the previous 5 years
• Chemotherapy for malignancy within the past 30 days
• High-dose systemic steroid (prednisone ≥0.5 mg/kg/day) in the past 30 days
• Receipt of blood product within 6 months before enrollment
• Significant acute or chronic infection within the previous 7 days or fever within the previous day
• Any serious chronic or progressive disease
• Any condition that might interfere with the study results.

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Novartis: collaborator

Related Publications (1)

• Song JY, Cheong HJ, Tsai TF, Chang HA, Choi MJ, Jeon JH, Kang SH, Jeong EJ, Noh JY, Kim WJ. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.

  PMID: 25980426 DERIVED

MeSH Terms

Conditions

Influenza, Human; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Hee Jin Cheong, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Joon Young Song, MD, PhD

  Korea University Guro Hospital

  STUDY DIRECTOR

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 22, 2014
• First Posted: August 26, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 27, 2014

Record last verified: 2014-08