Influenza Clinical Trial
— FluMistOfficial title:
A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older
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.
Status | Completed |
Enrollment | 3009 |
Est. completion date | November 2002 |
Est. primary completion date | November 2002 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | Jansen van Rensburg | Amanzimtoti | |
South Africa | Docnor House | Durban North | Dwazulu Natal |
South Africa | Hazelmed Family Practice | Hazelwood | Pretoria |
South Africa | Christiaan Tertius de Villiers | Scottburgh South |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC | Wyeth is now a wholly owned subsidiary of Pfizer |
South Africa,
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. Vacci — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | 15 days after dosing through 30Nov2002 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | The first episode of influenza-like illness | 15 days after dosing through 30Nov2002 | No | |
Secondary | 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 | No |
Secondary | Incidence of hospitalization | 15 days after dosing through 30Nov2002 | No | |
Secondary | Incidence of confirmed pneumonia | Pneumonia means one or more areas of acute interstitial or alveolar infiltrates documented radiographically | 15 days after dosing through 30Nov2002 | No |
Secondary | Incidence of death due to influenza-like illness | With or without confirmation by viral culture or PCR analysis | 15 days after dosing through 30Nov2002 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
Secondary | Incidence of local reactions | The local reactions were pain, redness (2 grades: any and significant), and swelling (also 2 grades). | Days 0-10 | Yes |
Secondary | Incidence of adverse events | Days 0-10 | Yes |
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