Skip to main content
OpenTrials
Completed

NCT Number: NCT02582047

Influenza Vaccine and Pneumococcal Vaccine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza, Human Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Orthomyxoviridae Infections Pneumococcal Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Ansan Hospital, Ansan, Kyoungido, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza vaccination with PPV23

Biological

GCflu and Pneumovax-23

Influenza vaccination with PCV13

Biological

GCflu and Prevenar-13

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Oct 21, 2015
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.