Influenza Vaccine and Pneumococcal Vaccine

Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients

Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Influenza, Human
• Intervention / Treatment: Biological: Influenza vaccination with PPV23; Biological: Influenza vaccination with PCV13

Detailed Description

During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07441
    • Hallym University Gangnam Sacred Hospital
  • Kyoungido
    • Ansan, Kyoungido, Korea, Republic of, 15355
      • Korea University Ansan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged ≥65 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
• History of Streptococcal pneumoniae infection within the previous 5 years

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Influenza vaccination with PPV23; concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine	Biological: Influenza vaccination with PPV23; GCflu and Pneumovax-23
Active Comparator: Influenza vaccination with PCV13; concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine	Biological: Influenza vaccination with PCV13; GCflu and Prevenar-13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rates (A/H1N1, A/H3N2, and B)	Seroconversion: 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	Change from baseline titer at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection rates (A/H1N1, A/H3N2, and B)	Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40	Change from baseline titer at 4 weeks
GMT folds (A/H1N1, A/H3N2, and B)	GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer	Change from baseline titer at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and duration of local and systemic adverse events	the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials	Monitor using a clinical diary for seven days after vaccination

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Hee Jin Cheong, MD, PhD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: influenza vaccine; pneumococcal vaccine; simultaneous vaccination
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Orthomyxoviridae Infections; Pneumococcal Infections; Influenza, Human
• Other Study ID Numbers: INFLUENZAPNEUMO