Influenza Vaccine and Pneumococcal Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza, Human, Pneumococcal Infections

Intervention / Treatment
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* Biological: Influenza vaccination with PPV23
* Biological: Influenza vaccination with PCV13


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza vaccine, pneumococcal vaccine, simultaneous vaccination