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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1143-8561 | Other Identifier | WHO |
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The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
Primary Objective:
Secondary Objectives:
Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.
Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants will receive one booster dose of SP059 (IMOVAX POLIO®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMOVAX POLIO®: Inactive Poliovirus Vaccine | Biological | 0.5 mL, Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay. | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio virus antibodies were assessed by virus neutralization assay. | Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination |
| Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set.
Participants were enrolled from 02 December 2013 to 28 April 2014 at 4 Clinical trial centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMOVAX POLIO® Vaccine Group | Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IMOVAX POLIO® Vaccine Group | Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay. | Anti-polio booster response was assessed in the per-protocol analysis set. | Posted | Number | Percentage of participants | Day 28 post-vaccination |
|
|
Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
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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 | IMOVAX POLIO® Vaccine Group | Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay |
| Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination |
| Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® | Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values. | Day 28 post-booster vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia. | Day 0 up to Day 7 post-vaccination |
| Hokkaido |
| Japan |
| Mie | Japan |
| Tokyo | Japan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Participants |
|
|
| Secondary | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio virus antibodies were assessed by virus neutralization assay. | Geometric mean titers was assessed in the per-protocol analysis set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination |
|
|
|
| Secondary | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay | Anti-polio booster response was assessed in the per-protocol analysis set. | Posted | Number | Percentage of participants | Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination |
|
|
|
| Secondary | Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® | Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values. | Geometric mean of individual titer ratios were assessed in the per-protocol analysis set. | Posted | Geometric Mean | 95% Confidence Interval | Titer Ratio | Day 28 post-booster vaccination |
|
|
|
| Secondary | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia. | Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set). | Posted | Number | Number of participants | Day 0 up to Day 7 post-vaccination |
|
|
|
| 0 |
| 60 |
| 47 |
| 60 |
| Injection Site Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastroenterities | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| Title | Measurements |
|---|---|
|
| Ant-polio 2 (post-vaccination) |
|
| Anti-polio 3 (pre-vaccination) |
|
| Anti-polio 3 (post-vaccination) |
|
| Title | Measurements |
|---|---|
|
| Anti-polio 2 (post-vaccination) |
|
| Anti-polio 3 (pre-vaccination) |
|
| Anti-polio 3 (post-vaccination) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Grade 3 Injection-site Erythema |
|
| Any Injection-site Swelling |
|
| Grade 3 Injection-site Swelling |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Any Malaise |
|
| Grade 3 Malaise |
|
| Any Myalgia |
|
| Grade 3 Myalgia |
|