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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-7693 | Other Identifier | WHO |
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The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan
Primary Objective:
Secondary Objective:
Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants age 9 to 17 years will receive a dose of Quadrivalent Influenza Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination. | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer. | Day 21 post-vaccination |
| Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei | 100 | Taiwan | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 100 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
Study participants were enrolled from 18 October 2013 to 19 November 2013 at 2 clinical sites in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadrivalent Influenza Vaccine | Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadrivalent Influenza Vaccine | Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation. |
| 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 | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. | Geometric mean titers were analyzed in the Immunogenicity Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Day 0 (pre-vaccination) and Day 21 post-vaccination |
|
Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
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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 | Quadrivalent Influenza Vaccine | Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | MedDRA v14 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Day 0 up to Day 7 post-vaccination |
| Taoyuan |
| 33342, |
| Taiwan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination. | Seroprotection was analyzed in the Immunogenicity Analysis Set. | Posted | Number | Percentage of participants | Day 0 (pre-vaccination) and Day 21 post-vaccination |
|
|
|
| Primary | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer. | Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set. | Posted | Number | Percentage of participants | Day 21 post-vaccination |
|
|
|
| Primary | Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. | Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers ratio | Day 0 (pre-vaccination) and Day 21 post-vaccination |
|
|
|
| Primary | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. | Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set. | Posted | Number | Percentage of participants | Day 0 up to Day 7 post-vaccination |
|
|
|
| 0 |
| 100 |
| 56 |
| 100 |
| Injection site Erythema | General disorders | MedDRA v14 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v14 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA v14 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v14 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v14 | 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
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| A/Texas/50/2012 (H3N2); Post-dose |
|
| B/Massachusetts/2/2012; Pre-dose |
|
| B/Massachusetts/2/2012; Post-dose |
|
| B/Brisbane/60/2008; Pre-dose |
|
| B/Brisbane/60/2008; Post-dose |
|
| Title | Measurements |
|---|---|
|
| B/Brisbane/60/2008 |
|
|
| B/Brisbane/60/2008 |
|
| Title | Measurements |
|---|---|
|
| Grade 3 Injection-site Erythema |
|
| Injection-site Swelling |
|
| Grade 3 Injection-site Swelling |
|
| Injection-site Induration |
|
| Grade 3 Injection-site Induration |
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| Injection-site Ecchymosis |
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| Grade 3 Injection-site Ecchymosis |
|
| Fever |
|
| Grade 3 Fever |
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| Headache |
|
| Grade 3 Headache |
|
| Malaise |
|
| Grade 3 Malaise |
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| Myalgia |
|
| Grade 3 Myalgia |
|
| Shivering |
|
| Grade 3 Shivering |
|