Influenza
Conditions
Brief summary
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.
Interventions
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.
BIOLOGICALTrivalent Inactivated Vaccine (TIV)
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).
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* who are aged at least 60 years or older at the time of enrollment; * who are determined by medical history, physical examination and clinical judgement to be eligible for this study; * who have provided written informed consent after the nature of the study has been explained; * who will be available for duration of the trial (from enrollment to November 30th, 2003); * who can be reached by study staff for the post-vaccination and weekly surveillance contacts \[telephone, clinic or home visit\].
Exclusion criteria
* who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period; * who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to Influenza study specific manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial; * with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (Subjects with other stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible). * with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to Influenza study specific manual); * with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents; * who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study; * have an immunosuppressed or an immunocompromised individual living in the same household; * with a documented history of hypersensitivity to egg or egg protein or any other component of the CAIV-T or TIV vaccine; * who were administered any live virus vaccine within one month prior to vaccination or expected to receive another live virus vaccine within one month of vaccination in this study; * for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study; * who received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted. * who receive any influenza vaccine in the 6 months prior to enrollment, or intend to receive a non-study influenza vaccine after enrollment; * with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Dosing through 30Nov2002 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 15 days after dosing through 30Nov2002 | 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. |
| 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 | 15 days after dosing through 30Nov2002 | 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. |
| The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes. | 15 days after dosing through 30Nov2002 | 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. |
| The first episode of influenza-like illness | 15 days after dosing through 30Nov2002 | — |
| Incidence of clinic visits | 15 days after dosing through 30Nov2002 | A possibility of multiple visits per subject; each visit will be counted once in the analysis. |
| Incidence of death due to influenza-like illness | 15 days after dosing through 30Nov2002 | With or without confirmation by viral culture or PCR analysis |
| Incidence of confirmed pneumonia | 15 days after dosing through 30Nov2002 | Pneumonia means one or more areas of acute interstitial or alveolar infiltrates documented radiographically |
| Incidence of seroconversion | Day 0-35 | 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). |
| Incidence of systemic reactogenicity events | Day 0-10 | 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. |
| Incidence of local reactions | Days 0-10 | The local reactions were pain, redness (2 grades: any and significant), and swelling (also 2 grades). |
| Incidence of adverse events | Days 0-10 | — |
| Incidence of hospitalization | 15 days after dosing through 30Nov2002 | — |
Countries
South Africa
Outcome results
None listed