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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
| Osaka University | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.
The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. We compare the immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine with that of separate administration.
162 Participants are randomly assigned to one of the two study groups; Simultaneous administration group: receive injections of pneumococcal vaccine and influenza vaccine simultaneously.
Sequential administration group: receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
We compare the immunogenicity of the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous administration group | Active Comparator | The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season. |
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| Sequential administration group | Active Comparator | The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous administration of Pneumovax NP® and Fluvic HA syringe® | Biological | Injections of pneumococcal vaccine and influenza vaccine simultaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. | The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody. | 1month after the dose of PPV23 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody. | Positive antibody response was defined as ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination in respective serotypes of the pneumococcal antibody. | 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kei Nakashima, MD | Department of Pulmonary Medicine, Kameda Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonary Medicine, Kameda Medical Center | Kamogawa | Chiba | 2968602 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20014948 | Background | Walter ND, Taylor TH, Shay DK, Thompson WW, Brammer L, Dowell SF, Moore MR; Active Bacterial Core Surveillance Team. Influenza circulation and the burden of invasive pneumococcal pneumonia during a non-pandemic period in the United States. Clin Infect Dis. 2010 Jan 15;50(2):175-83. doi: 10.1086/649208. | |
| 16771912 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Simultaneous Administration Group | The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season. Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sequential administration of Pneumovax NP® and Fluvic HA syringe® | Biological | Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. |
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| The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A) | Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration. | Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2) |
| The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine. | Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination. | 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2) |
| Oishi K, Yoshimine H, Watanabe H, Watanabe K, Tanimura S, Kawakami K, Iwagaki A, Nagai H, Goto H, Kudoh S, Kuriyama T, Fukuchi Y, Matsushima T, Shimada K, Matsumoto K, Nagatake T. Drug-resistant genes and serotypes of pneumococcal strains of community-acquired pneumonia among adults in Japan. Respirology. 2006 Jul;11(4):429-36. doi: 10.1111/j.1440-1843.2006.00867.x. |
| 19871167 | Background | Hirst GK. THE QUANTITATIVE DETERMINATION OF INFLUENZA VIRUS AND ANTIBODIES BY MEANS OF RED CELL AGGLUTINATION. J Exp Med. 1942 Jan 1;75(1):49-64. doi: 10.1084/jem.75.1.49. |
| 19556517 | Background | Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25. |
| 16549029 | Background | Grabowska K, Hogberg L, Penttinen P, Svensson A, Ekdahl K. Occurrence of invasive pneumococcal disease and number of excess cases due to influenza. BMC Infect Dis. 2006 Mar 20;6:58. doi: 10.1186/1471-2334-6-58. |
| 29561248 | Derived | Nakashima K, Aoshima M, Ohfuji S, Yamawaki S, Nemoto M, Hasegawa S, Noma S, Misawa M, Hosokawa N, Yaegashi M, Otsuka Y. Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial. Hum Vaccin Immunother. 2018;14(8):1923-1930. doi: 10.1080/21645515.2018.1455476. Epub 2018 May 14. |
| FG001 | Sequential Administration Group | The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016. Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. |
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In the sequential administration group, we have 1 patient with eligibility error. Thus, we evaluated 81 patients in simultaneous administration group and 80 patients in sequential administration group after excluding 1 patient for ineligibility.
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| ID | Title | Description |
|---|---|---|
| BG000 | Simultaneous Administration Group | The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season. Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously. |
| BG001 | Sequential Administration Group | The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016. Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. | The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody. | In the sequential group, 5 patients were excluded from primary analysis because of the reasons below. 1 patient: eligibility error, 1 patient: lost to follow-up (patient's decision), 3 patient: discontinued intervention (1 patient: fever, 2 patients: patient's decision | Posted | Count of Participants | Participants | 1month after the dose of PPV23 |
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| Secondary | The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody. | Positive antibody response was defined as ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination in respective serotypes of the pneumococcal antibody. | Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.intervention (1 patient: fever, 2 patients: patient's decision | Posted | Count of Participants | Participants | 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2) |
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| Secondary | The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A) | Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration. | Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period. | Posted | Geometric Mean | 95% Confidence Interval | micrograms per milliliter | Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2) |
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| Secondary | The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine. | Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination. | Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period. | Posted | Count of Participants | Participants | 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2) |
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Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine.
In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simultaneous Administration Group | The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season. Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously. | 0 | 81 | 20 | 81 | ||
| EG001 | Sequential Administration Group | The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016. Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. | 0 | 80 | 31 | 79 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Joint pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain of axilla | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kei Nakashima, Associate Chief | Department of Pulmonary Medicine, Kameda Medical Center | 81-4-7092-2211 | 8614 | kei.7.nakashima@gmail.com |
| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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