Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-2719 | Other Identifier | WHO | |
| 2011-005101-79 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).
Primary Objective:
Secondary Objectives:
All participants will receive a single injection of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2), and also monitored for safety for up to 6 months post-vaccination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: QIV Lot 1 | Experimental | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1. |
|
| Group 2: QIV Lot 2 | Experimental | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2. |
|
| Group 3: QIV Lot 3 | Experimental | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3. |
|
| Group 4: TIV | Active Comparator | Participants will receive the Trivalent Influenza Vaccine (TIV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering | Day 0 to 7 post-vaccination |
| Percentage of participants reporting unsolicited systemic reactions including serious adverse events (SAE) throughout the trial. | An SAE is defined as any untoward medical occurrence that at any dose (including overdose): Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability / incapacity; Is a congenital anomaly / birth defect; Is an important medical event. | Day 0 up to six months post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with seroprotection and seroconversion post vaccination with either the investigational QIV, or TIV or the licensed 2011-2012 TIV | Immunogenicity assessed by hemagglutination inhibition (HAI) assay for each vaccine strain. Seroprotection defined as a post-vaccination titer of ≥ 40 (1/dil); Seroconversion defined for participants with a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer of ≥ 40 (1/dil). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25843270 | Derived | Cadorna-Carlos JB, Nolan T, Borja-Tabora CF, Santos J, Montalban MC, de Looze FJ, Eizenberg P, Hall S, Dupuy M, Hutagalung Y, Pepin S, Saville M. Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Vaccine. 2015 May 15;33(21):2485-92. doi: 10.1016/j.vaccine.2015.03.065. Epub 2015 Apr 2. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quadrivalent Influenza Vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular |
|
| Quadrivalent Influenza Vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular |
|
| 2011 to 2012 Trivalent Influenza Vaccine | Biological | 0.5 mL, Intramuscular |
|
| Day 21 post-vaccination |
| Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine. | 21 Days post-vaccination |
| Westmead NSW |
| 2145 |
| Australia |
| Calamba Laguna City | Philippines |
| City of Muntinlupa | 1781 | Philippines |
| Malate, Manila | Philippines |
| Quezon City | Philippines |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided