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Influenza Vaccine and Pneumococcal Vaccine

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ClinicalTrials.gov Identifier: NCT02582047
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Hee Jin Cheong, Korea University Guro Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza, Human Pneumococcal Infections Biological: Influenza vaccination with PPV23 Biological: Influenza vaccination with PCV13 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




Primary Outcome Measures :
  1. Seroconversion rates (A/H1N1, A/H3N2, and B) [ Time Frame: Change from baseline titer at 4 weeks ]
    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


Secondary Outcome Measures :
  1. Seroprotection rates (A/H1N1, A/H3N2, and B) [ Time Frame: Change from baseline titer at 4 weeks ]
    Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40

  2. GMT folds (A/H1N1, A/H3N2, and B) [ Time Frame: Change from baseline titer at 4 weeks ]
    GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer


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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02582047


Locations
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Korea, Republic of
Korea University Ansan Hospital
Ansan, Kyoungido, Korea, Republic of, 15355
Hallym University Gangnam Sacred Hospital
Seoul, Korea, Republic of, 07441
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
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Principal Investigator: Hee Jin Cheong, MD, PhD Korea University Guro Hospital

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Responsible Party: Hee Jin Cheong, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT02582047     History of Changes
Other Study ID Numbers: INFLUENZAPNEUMO
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by Hee Jin Cheong, Korea University Guro Hospital:
influenza vaccine
pneumococcal vaccine
simultaneous vaccination

Additional relevant MeSH terms:
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Influenza, Human
Pneumococcal Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs