Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

Study Overview
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Brief Summary
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This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.

Official Title
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A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination

Conditions
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Influenza

Intervention / Treatment
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* Biological: 13 valent pneumococcal conjugate vaccine
* Biological: 13 valent pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 50 to 59 years Determined by medical history, physical examination and clinical judgement to be eligible for the study Able to complete electronic diary Available for the 5 year 9 month duration of the study Exclusion Criteria: Previous vaccination with any licensed or experimental pneumococcal vaccine Allergic to egg proteins and chicken proteins History of Guillian-Barre syndrome Vaccination with TIV within 6 months before study start Vaccination with diphtheria-containing vaccine within 6 months of study start Serious chronic disorders including immunodeficiency or metastatic malignancy Known or suspected hypersensitivity to any vaccine or vaccine component

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 59 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5 | Biological: 13 valent pneumococcal conjugate vaccine<br>* TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5<br>* Other names: 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle;|
| Other: 2<br>arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5 | Biological: 13 valent pneumococcal conjugate vaccine<br>* TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5<br>* Other names: 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1 | Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen. | 1 month after Dose 1 | 
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | 1 month after 13vPnC Dose at year 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal Conjugate Vaccine