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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5427 | Other Identifier | WHO |
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The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults.
Primary Objective:
To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.
Observational Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives) |
|
| Study Group 2 | Active Comparator | Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV) |
|
| Study Group 3 | Active Comparator | Participants will receive the Quadrivalent Influenza Vaccine (QIV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2009-2010 Trivalent Influenza Virus Vaccine | Biological | 0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity. | Day 0 up to 7 days post-vaccination |
| Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | 21 Days post last vaccination |
| Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | 21 Days post last vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil) |
Inclusion Criteria :
Exclusion Criteria :
For all subjects:
For subjects > 6 months to < 5 years of age:
For subjects 18 years of age and older:
Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months.
Diabetes mellitus requiring pharmacological control.
Person deprived of freedom by an administrative or court order (having legal or medical guardian).
For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
Any subject with the following conditions is not eligible for enrollment. However, the subject may be enrolled subsequently if the condition has resolved and enrollment is still ongoing and the subject meets all other inclusion/exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham | North Carolina | 27704 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 600 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
The study participants were enrolled from 01 October through 05 November 2009 in 4 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group 1 (2009-2010 TIV) | Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives) |
| FG001 | Study Group 2 (2008-2009 TIV) | Participants received the 2008-2009 Trivalent Influenza Vaccine |
| FG002 | Study Group 3 (QIV) | Participants received the Quadrivalent Influenza Vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV) |
| BG001 | Study Group 2 (2008-2009 Trivalent Influenza Vaccine) |
| 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 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity. | Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population. | Posted | Number | Participants | Day 0 up to 7 days post-vaccination |
Adverse events data were collected from the day of vaccination (Day 0) up to 28 days 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 | Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | Gastrointestinal disorders | MedDRA version 12.0 | Non-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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|
| 2008-2009 Trivalent Influenza Virus Vaccine | Biological | 0.25 mL, Intramuscular; 0.5 mL, Intramuscular. |
|
|
| Quadrivalent Influenza Virus Vaccine | Biological | 0.5 mL, Intramuscular |
|
| Day 0 (pre-vaccination) and Day 21 post final vaccination |
| Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | 21 Days post last vaccination |
| Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. | Day 21 post-vaccination |
| Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | 21 Days post last vaccination |
| Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. | Day 0 up to 21 days post-vaccination |
| Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil). | Day 0 (pre-vaccination) and Day 21 post final vaccination |
| Cincinnati |
| Ohio |
| 45249 |
| United States |
| Jefferson Hills | Pennsylvania | 15025 | United States |
| Norfolk | Virginia | 23507 | United States |
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
| BG002 | Study Group 3 (Quadrivalent Influenza Vaccine) | Participants received the Quadrivalent Influenza Vaccine (QIV) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
|
| Primary | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 Days post last vaccination |
|
|
|
| Other Pre-specified | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil) | Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 21 post final vaccination |
|
|
|
| Other Pre-specified | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 Days post last vaccination |
|
|
|
| Other Pre-specified | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. | Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. | Posted | Number | Participants | Day 21 post-vaccination |
|
|
|
| Other Pre-specified | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 Days post last vaccination |
|
|
|
| Other Pre-specified | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. | Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population | Posted | Number | Participants | Day 0 up to 21 days post-vaccination |
|
|
|
| Other Pre-specified | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil). | Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 21 post final vaccination |
|
|
|
| Primary | Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV). | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 Days post last vaccination |
|
|
|
| 0 |
| 220 |
| 105 |
| 220 |
| EG001 | Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV) | 0 | 190 | 84 | 190 |
| EG002 | Study Group 3 (Quadrivalent Influenza Vaccine) | Participants received the Quadrivalent Influenza Vaccine (QIV) | 2 | 190 | 91 | 190 |
| Chest pain | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 12.0 | Non-systematic Assessment |
|
| Injection site Pain | General disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Appetite lost | Metabolism and nutrition disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Crying abnormal | Psychiatric disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 12.0 | Systematic Assessment |
|
| Shivering | General disorders | MedDRA version 12.0 | 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 |
| B/Florida/04/2006 (0, 188, 190) |
|
|
| A/H3N2, Pre-vaccination (186, 187, 190) |
|
| A/H3N2, Post-vaccination (187, 188, 190) |
|
| B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) |
|
| B/Brisbane/60/2008, Post-vaccination (187, 0, 190) |
|
| B/Florida/04/2006, Pre-vaccination (0, 187, 190) |
|
| B/Florida/04/2006, Post-vaccination (0, 187, 190) |
|
| A/H1N1, Post-vaccination (187, 188, 190) |
|
| A/H3N2, Pre-vaccination (186, 188, 190) |
|
| A/H3N2, Post-vaccination (187, 188, 190) |
|
| B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) |
|
| B/Brisbane/60/2008, Post-vaccination (187, 0, 190) |
|
| B/Florida/04/2006, Pre-vaccination (0, 187, 190) |
|
| B/Florida/04/2006, Post-vaccination (0, 187, 190) |
|
|
| B/Brisbane/60/2008 (187, 0, 190) |
|
| B/Florida/04/2006 (0, 188, 190) |
|
| A/H1N1, Post-vaccination (214, 187, 189) |
|
| A/H3N2, Pre-vaccination (214, 187, 189) |
|
| A/H3N2, Post-vaccination (214, 188, 189) |
|
| B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) |
|
| B/Brisbane/60/2008, Post-vaccination (215, 0, 189) |
|
| B/Florida/04/2006, Pre-vaccination (0, 186, 189) |
|
| B/Florida/04/2006, Post-vaccination (0, 187, 189) |
|
|
| A/H3N2 Pre-vaccination (214, 187, 189) |
|
| A/H3N2 Post-vaccination (213, 187, 189) |
|
| B/Brisbane/60/2008 Pre-vaccination (214, 0, 189) |
|
| B/Brisbane/60/2008 Post-vaccination (214, 0, 189) |
|
| B/Florida/04/2006 Pre-vaccination (0, 186, 189) |
|
| B/Florida/04/2006 Post-vaccination (0, 186, 189) |
|
|
| A/H3N2, Pre-vaccination (214, 187, 189) |
|
| A/H3N2, Post-vaccination (214, 188, 189) |
|
| B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) |
|
| B/Brisbane/60/2008, Post-vaccination (215, 0, 189) |
|
| B/Florida/04/2006, Pre-vaccination (0, 186, 189) |
|
| B/Florida/04/2006, Post-vaccination (0, 187, 189) |
|