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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | Experimental | A single 0.2 mL dose of 10^7 fluorescent focus units was administered intranasally. |
|
| Trivalent Inactivated Vaccine (TIV) | Active Comparator | A single dose was administered by intramuscular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T) | Biological | Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5. |
| Measure | Description | Time Frame |
|---|---|---|
| The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine. | The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted. | Dosing through 30Nov2002 |
| Measure | Description | Time Frame |
|---|---|---|
| The first episode of a culture-confirmed influenza-illness, caused by any community-acquired subtype, which occurs at least 15 days following receipt of a dose of study vaccine. | The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walker, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Docnor House | Durban North | Dwazulu Natal | South Africa | |||
| Hazelmed Family Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21440036 | Result | Forrest BD, Steele AD, Hiemstra L, Rappaport R, Ambrose CS, Gruber WC. A prospective, randomized, open-label trial comparing the safety and efficacy of trivalent live attenuated and inactivated influenza vaccines in adults 60 years of age and older. Vaccine. 2011 May 9;29(20):3633-9. doi: 10.1016/j.vaccine.2011.03.029. Epub 2011 Apr 5. |
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| Trivalent Inactivated Vaccine (TIV) | Biological | Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults). |
|
| 15 days after dosing through 30Nov2002 |
| The first episode in a study subject of a culture-confirmed influenza illness caused by community-acquired virus of each of the subtypes antigenically similar to those contained in the vaccine | The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted. | 15 days after dosing through 30Nov2002 |
| The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes. | The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted. | 15 days after dosing through 30Nov2002 |
| The first episode of influenza-like illness | 15 days after dosing through 30Nov2002 |
| Incidence of clinic visits | A possibility of multiple visits per subject; each visit will be counted once in the analysis. | 15 days after dosing through 30Nov2002 |
| Incidence of hospitalization | 15 days after dosing through 30Nov2002 |
| Incidence of confirmed pneumonia | Pneumonia means one or more areas of acute interstitial or alveolar infiltrates documented radiographically | 15 days after dosing through 30Nov2002 |
| Incidence of death due to influenza-like illness | With or without confirmation by viral culture or PCR analysis | 15 days after dosing through 30Nov2002 |
| Incidence of seroconversion | Seroconversion is defined as at least a 4-fold increase in titer from baseline to the sample 35 plus or minus 7 days after vaccination. all subjects were to provide serum samples at 2 time points: at study visit 1 prior to vaccination with CAIV-T or TIV, and 35 days ± 7 days following vaccination (study visit 2). | Day 0-35 |
| Incidence of systemic reactogenicity events | The 12 systemic reactions were fever with 3 grades defined as ≥37.2°C, ≥38.6°C, and ≥40°C based on the temperature reported on the diary card in addition to the 9 events reported on the diary card. | Day 0-10 |
| Incidence of local reactions | The local reactions were pain, redness (2 grades: any and significant), and swelling (also 2 grades). | Days 0-10 |
| Incidence of adverse events | Days 0-10 |
| Hazelwood |
| Pretoria |
| South Africa |
| Jansen van Rensburg | eManzimtoti | South Africa |
| Christiaan Tertius de Villiers | Scottburgh South | South Africa |
| 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 |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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