Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00128167
Collaborator
(none)
8,500
161
14
52.8
3.8
Study Details
Study Description
Brief Summary
The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
A Randomized, Double-Blind Trial to Assess the Safety and Relative Efficacy of CAIV-T Against Inactivated Influenza Vaccine in Children 6-59 Months of Age
Study Start Date
:
Oct 1, 2004
Study Completion Date
:
Dec 1, 2005
Outcome Measures
Primary Outcome Measures
- The primary efficacy endpoint of this study is the relative efficacy of CAIV-T []
- compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the []
- influenza surveillance period and at least 14 days after the last required vaccination []
Secondary Outcome Measures
- Culture-confirmed symptomatic influenza infection regardless of antigenic match []
- Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains []
- Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match []
- Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and []
- Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match []
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 59 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Age 6-59 months of age (not yet reached their 5th birthday)
-
Parent or guardian available by telephone
-
Available for illness visits at clinic or at home during the influenza surveillance period
-
Written informed consent (and Health Insurance Portability and Accountability Act [HIPAA] authorization for U.S. Participants) obtained from the participant's parent or legal guardian and
-
Ability of the parent/guardian to understand and comply with the requirements of the protocol
Exclusion Criteria:
-
History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein
-
History of hypersensitivity to gentamicin
-
Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
-
History of Guillain-Barre syndrome
-
Medically-diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within the previous 42 days by parent report or chart review (e.g., children with recent persistent asthma are excluded), or history of severe asthma
-
Acute febrile (>100.0 degrees F or >37.8 degrees C oral or equivalent) illness or acute respiratory illness, including sore throat, within three days prior to enrollment
-
Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study
-
Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study
-
Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt during this study
-
Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study
-
Administration of any live virus vaccine within 30 days prior to enrollment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination
-
Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination
-
Close contact who is severely immunocompromised (e.g., transplant recipient)
-
Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study and
-
Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Consultants, Inc | Hoover | Alabama | United States | 35216 |
| 2 | University of Alabama | Tuscaloosa | Alabama | United States | 35401 |
| 3 | Little Rock Allergy and Asthma Clinical | Little Rock | Arkansas | United States | 72205 |
| 4 | Friendly Care Medical Group | Anaheim | California | United States | 92805 |
| 5 | Impact Clinical Trials | Beverly Hills | California | United States | 90211 |
| 6 | Family Medical Center | Foothill Ranch | California | United States | 92610 |
| 7 | Edinger Mecial Group | Fountain Valley | California | United States | 92708-7504 |
| 8 | Fresno Childrens Medical Group, Inc. | Fresno | California | United States | 93720 |
| 9 | Heathcare Partners Medical Group | Los Angeles | California | United States | 90015 |
| 10 | Kaiser Permanente Vaccine Study Center | Oakland | California | United States | 94612 |
| 11 | PRA Trials | Rolling Hills Estates | California | United States | 90274 |
| 12 | Benchmark Research | San Francisco | California | United States | 94102 |
| 13 | Convenience Care | West Covina | California | United States | 91790 |
| 14 | Norwich Pediatric Group, PC | Norwich | Connecticut | United States | 06360 |
| 15 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20057 |
| 16 | Clinical Research Care & Resource Center, Inc | Miami | Florida | United States | 33156 |
| 17 | Suncoast Clinical Research | New Port Richey | Florida | United States | 34652 |
| 18 | Pediatric Research Center of South Florida | Palm Beach Gardens | Florida | United States | 33410 |
| 19 | Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases | Atlanta | Georgia | United States | 30322 |
| 20 | Pediatrics and Adolescent Medicine, P.A. | Marietta | Georgia | United States | 30062 |
| 21 | Medical Parameters | Martinez | Georgia | United States | 30907 |
| 22 | Rush University Medical Center/University Consultatnts in Allergy and Immunology | Chicago | Illinois | United States | 60612 |
| 23 | Children's Memorial Hospital | Chicago | Illinois | United States | 60641 |
| 24 | Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | United States | 61761 |
| 25 | South Bend Clinic | South Bend | Indiana | United States | 46617 |
| 26 | Heart of America Research Institute | Shawnee Mission | Kansas | United States | 66216 |
| 27 | Heart of America Research Institute-Topeka | Topeka | Kansas | United States | 66614 |
| 28 | Kentucky Pediatrics/Adult Research Inc. | Bardstown | Kentucky | United States | 40004 |
| 29 | University Child Health Specialists, PCTU | Louisville | Kentucky | United States | 40202 |
| 30 | Clinical Trials Management, LLC/The Pediatric Clinic | Bogalusa | Louisiana | United States | 70427 |
| 31 | Dolby Providers LLC | New Orleans | Louisiana | United States | 70128 |
| 32 | Boston University Medical Center | Boston | Massachusetts | United States | 02118 |
| 33 | Woburn Pediatric Associates | Woburn | Massachusetts | United States | 01801 |
| 34 | Odyssey Research | Dearborn | Michigan | United States | 48126 |
| 35 | Chidren's Hospital of Michigan | Detroit | Michigan | United States | 48201 |
| 36 | Center for Vaccine Development | Saint Louis | Missouri | United States | 63110 |
| 37 | Bozeman Urgent Care Center | Bozeman | Montana | United States | 59715 |
| 38 | Creighton/UNMC Pediatric Infectious Disease | Omaha | Nebraska | United States | 68131 |
| 39 | Meridian Clinical Research, LLC | Omaha | Nebraska | United States | 68134 |
| 40 | Henderson Pediatrics | Henderson | Nevada | United States | 89015 |
| 41 | Clinical Research Center of Nevada | Las Vegas | Nevada | United States | 89104 |
| 42 | Summit Pediatric Pulmonary | Summit | New Jersey | United States | 07901 |
| 43 | United Medical Associates | Binghamton | New York | United States | 13901 |
| 44 | Jacobi Medical Center | Bronx | New York | United States | 10461 |
| 45 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
| 46 | Barbara Dzierzek/PharmaTrials, Inc. | Brooklyn | New York | United States | 11222 |
| 47 | Health Sciences Research Center | Cortland | New York | United States | 13045 |
| 48 | Endwell Family Physicians | Endwell | New York | United States | 13760 |
| 49 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 50 | Clarkstown Pediatric Associates | Nanuet | New York | United States | 10954 |
| 51 | CPMC Research Pharmacy | New York | New York | United States | 10032 |
| 52 | Elmwood Pediatrics | Rochester | New York | United States | 14620 |
| 53 | University Rochester Medical Center | Rochester | New York | United States | 14642 |
| 54 | Northeast Pediatrics and Adolescent Medicine | Syracuse | New York | United States | 13210 |
| 55 | Boone Pediatric Center | Boone | North Carolina | United States | 28607 |
| 56 | University of North Carolina Department of Pediatrics | Chapel Hill | North Carolina | United States | 79599 |
| 57 | Purcell Clinic | Laurinburg | North Carolina | United States | 28352 |
| 58 | North Carolina Clinical Research | Raleigh | North Carolina | United States | 27607 |
| 59 | Sylva Pediatrics Associates | Sylva | North Carolina | United States | 28779 |
| 60 | Ford, Simpson, Lively and Rice Pediatrics | Winston-Salem | North Carolina | United States | 27103 |
| 61 | Odyssey Research | Bismarck | North Dakota | United States | 58501 |
| 62 | Dakota Clinic/Innovis Health | Fargo | North Dakota | United States | 58104 |
| 63 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 64 | Pediatric Associates of Mt. Carmel | Cincinnati | Ohio | United States | 45245 |
| 65 | Ohio Pediatrics | Huber Heights | Ohio | United States | 45424 |
| 66 | Shelly Senders and Associates | University Heights | Ohio | United States | 44118 |
| 67 | Grand Prairie Pediatric and Allergy Clinic | Oklahoma City | Oklahoma | United States | 73132 |
| 68 | Hillcrest Medical Group/Utica Park Clinic | Tulsa | Oklahoma | United States | 74104 |
| 69 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15123 |
| 70 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 71 | Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | United States | 15241-3100 |
| 72 | Asthma & Allergy Research Associates | Upland | Pennsylvania | United States | 19013 |
| 73 | East Bay Pediatrics | Barrington | Rhode Island | United States | 02806 |
| 74 | Omega Medical Research | Cranston | Rhode Island | United States | 02920 |
| 75 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 76 | Northridge Brown Clinic | Watertown | South Dakota | United States | 57201 |
| 77 | Medsouth Healthcare | Dyersburg | Tennessee | United States | 38024 |
| 78 | Holston Medical Group Pediatrics | Kingsport | Tennessee | United States | 37660 |
| 79 | Murfressboro Medical Clinic | Murfreesboro | Tennessee | United States | 37130 |
| 80 | Pediatric Clincal Research Office | Nashville | Tennessee | United States | 37232-2573 |
| 81 | Wells Branch Medical Center | Austin | Texas | United States | 78728 |
| 82 | Sadler Clinic/Healthsouth Clinical Research | Conroe | Texas | United States | 77304 |
| 83 | Pediatric Allergy/Immunology Associates, PA | Dallas | Texas | United States | 75230 |
| 84 | Healthfirst Medical Group | Fort Worth | Texas | United States | 76135 |
| 85 | Med-Pro Research Inc. | Houston | Texas | United States | 77004 |
| 86 | Scott and White/Pediatric Clinic | Killeen | Texas | United States | 76451 |
| 87 | Rd Clinical Research Inc. | Lake Jackson | Texas | United States | 77566 |
| 88 | Central Texas Health Research | New Braunfels | Texas | United States | 78130 |
| 89 | Benchmark Research | San Angelo | Texas | United States | 76904 |
| 90 | Quality Assurance Research Center | San Antonio | Texas | United States | 78207 |
| 91 | Wee Care Pediatrics | Layton | Utah | United States | 84041 |
| 92 | Cottonwood Pediatrics | Murray | Utah | United States | 84107 |
| 93 | Bear Care Pediatrics | Ogden | Utah | United States | 84450 |
| 94 | Alpine Pediatrics | Pleasant Grove | Utah | United States | 84062 |
| 95 | Utah Valley Pediatrics | Provo | Utah | United States | 84604 |
| 96 | J. Lewis Research Inc. | Salt Lake City | Utah | United States | 84109 |
| 97 | J. Lewis Research, Inc. | Salt Lake City | Utah | United States | 84121 |
| 98 | Families First Pediatrics | South Jordan | Utah | United States | 84095 |
| 99 | J. Lewis Research/Southwest Family Medicine | West Jordan | Utah | United States | 84084 |
| 100 | PI-Coor Clinical Research, LLC | Burke | Virginia | United States | 22015 |
| 101 | Respiratory Disease Study Unit | Charlottesville | Virginia | United States | 22901 |
| 102 | Health Research of Hampton Roads, Inc | Newport News | Virginia | United States | 23606 |
| 103 | Center for Pediatric Research | Norfolk | Virginia | United States | 23510 |
| 104 | VCU Campus Children's Pavilion/Pediatric Clinical Trials Office | Richmond | Virginia | United States | 23219 |
| 105 | Advanced Pediatrics | Vienna | Virginia | United States | 22180-4224 |
| 106 | Univeristy Pediatrics | Huntington | West Virginia | United States | 25701 |
| 107 | Monroe Medical Foundation | Monroe | Wisconsin | United States | 53566 |
| 108 | Sint-Vincentiusziekenhuis Sint-Vincentiusstraat | Antwerp | Belgium | 2018 | |
| 109 | Private Practice | Berchem | Belgium | 2600 | |
| 110 | UVC Brugmann | Brussel | Belgium | 1030 | |
| 111 | AZ-VUB Paediatric Clinic | Brussel | Belgium | 1090 | |
| 112 | Private Practice | Drongen | Belgium | 9031 | |
| 113 | KUL Dienst Jeugdgezondheidszorg | Leuven | Belgium | 3000 | |
| 114 | Private Practice | Schoten | Belgium | 2900 | |
| 115 | Private Practice | Tienen | Belgium | 3300 | |
| 116 | Private Practice | Wondelgem | Belgium | 9032 | |
| 117 | IN Boskovice a. s. Detské oddelení | Boskovice | Czechia | 680 21 | |
| 118 | In Boskovice a.s. Detske oddeleni | Boskovice | Czechia | 680 21 | |
| 119 | Privantni praxe praktickenho | Lysice | Czechia | 679 71 | |
| 120 | Privátní praxe praktického lékare pro deti a dorost Lysice | Lysice | Czechia | 679 71 | |
| 121 | Nemocnice s poliklinikou v Moste | Most | Czechia | 434 64 | |
| 122 | STOPED s.r.o. | Plzen | Czechia | 301 66 | |
| 123 | Department of Pediatrics | Chai Wan | Hong Kong | ||
| 124 | Department of Pediatrics/Adolescent Medicine | Hang Hau | Hong Kong | ||
| 125 | Department of Pediatrics - Paediatrics Unit | Kowloon | Hong Kong | ||
| 126 | Department of Pediatrics/Adolescent Medicine | Lai Chi Kok | Hong Kong | ||
| 127 | Department of Pediactrics | Shatin | Hong Kong | ||
| 128 | Springhill Surgery | Bangor County | Ireland | BT 19 1PP | |
| 129 | Randalstown Health Centre | Randalsotown | Ireland | BT413AE | |
| 130 | Nottinghill Practice, Whiteabbey Health Centre | Whiteabbey | Ireland | BT37 9QN | |
| 131 | Department of Pediatrics | Seoul | Korea, Republic of | 120-752 | |
| 132 | Dept. of Pediatrics | Seoul | Korea, Republic of | 130-702 | |
| 133 | Department of Pediatrics | Seoul | Korea, Republic of | 135-230 | |
| 134 | Department of Pediatrics | Seoul | Korea, Republic of | 152-703 | |
| 135 | Department of Pediatrics | Changhua | Taiwan | 500 | |
| 136 | Department of Pediatrics | Taichung | Taiwan | 403 | |
| 137 | Department of Pediatrics | Taipei | Taiwan | 100 | |
| 138 | Department of Pediatrics | Taipei | Taiwan | 104 | |
| 139 | Department of Pediatrics | Taoyuan | Taiwan | 333 | |
| 140 | Ashville Medical Center | Barnsely | South Yorks | United Kingdom | S703RJ |
| 141 | Townhead Surgery | Ayrshire | United Kingdom | KA12 0AY | |
| 142 | Cathcart Street Practice | Ayr | United Kingdom | KA71BJ | |
| 143 | Stonehill Medical Centre | Bolton | United Kingdom | BL49Q2 | |
| 144 | The Orchard Medical Centre | Bristol | United Kingdom | BS15 2NJ | |
| 145 | The Staploe Medical Centre | Cambs | United Kingdom | CB7 5JD | |
| 146 | Avondale Surgery Research | Chesterfield | United Kingdom | S404TF | |
| 147 | Saltash Health Centre | Cornwall | United Kingdom | PL12 4BU | |
| 148 | Woodend Health Centre | Coventry | United Kingdom | CV2 1XA | |
| 149 | Gabels Medical Centre | Coventry | United Kingdom | CV6 4DD | |
| 150 | Govind Health Cenre | Coventry | United Kingdom | Cv66 4DD | |
| 151 | Woolwell Medical Centre | Devon Plymouth | United Kingdom | ||
| 152 | The Medical Centre | East Horley | United Kingdom | KT246QT | |
| 153 | Valleyfield Health Centre | Fife | United Kingdom | KY128SJ | |
| 154 | Castlemilk Health Centre | Glasgow | United Kingdom | G459AW | |
| 155 | Kingsway Medical | Glasgow | United Kingdom | ||
| 156 | Layton Medical Centre | Lancs | United Kingdom | FY37EN | |
| 157 | Greenwood & Sneinton Family Medical Practice | Nottingham | United Kingdom | NG37DQ | |
| 158 | Landsdowne Road Yaxley | Peterborough | United Kingdom | PE7 3JL | |
| 159 | Knowle House Surgery | Plymouth | United Kingdom | PL5 3JD | |
| 160 | Wansford Surgery | Wansford | United Kingdom | PE86LP | |
| 161 | Sherbourne Medical Centre | Warwick Shire | United Kingdom | CV324RA |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Study Director: Robert Walker, M.D., MedImmune LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00128167
Other Study ID Numbers:
- MI-CP111
First Posted:
Aug 9, 2005
Last Update Posted:
Sep 13, 2021
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms: