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Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Liquid CAIV-T
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Research Consultants, Inc
  • University of Alabama
  • Little Rock Allergy and Asthma Clinical
  • Friendly Care Medical Group
  • Impact Clinical Trials
  • Family Medical Center
  • Edinger Mecial Group
  • Fresno Childrens Medical Group, Inc.
  • Heathcare Partners Medical Group
  • Kaiser Permanente Vaccine Study Center
  • PRA Trials
  • Benchmark Research
  • Convenience Care
  • Norwich Pediatric Group, PC
  • Georgetown University Medical Center
  • Clinical Research Care & Resource Center, Inc
  • Suncoast Clinical Research
  • Pediatric Research Center of South Florida
  • Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases
  • Pediatrics and Adolescent Medicine, P.A.
  • Medical Parameters
  • Rush University Medical Center/University Consultatnts in Allergy and Immunology
  • Children's Memorial Hospital
  • Sneeze, Wheeze, & Itch Associates, LLC
  • South Bend Clinic
  • Heart of America Research Institute
  • Heart of America Research Institute-Topeka
  • Kentucky Pediatrics/Adult Research Inc.
  • University Child Health Specialists, PCTU
  • Clinical Trials Management, LLC/The Pediatric Clinic
  • Dolby Providers LLC
  • Boston University Medical Center
  • Woburn Pediatric Associates
  • Odyssey Research
  • Chidren's Hospital of Michigan
  • Center for Vaccine Development
  • Bozeman Urgent Care Center
  • Creighton/UNMC Pediatric Infectious Disease
  • Meridian Clinical Research, LLC
  • Henderson Pediatrics
  • Clinical Research Center of Nevada
  • Summit Pediatric Pulmonary
  • United Medical Associates
  • Jacobi Medical Center
  • Montefiore Medical Center
  • Barbara Dzierzek/PharmaTrials, Inc.
  • Health Sciences Research Center
  • Endwell Family Physicians
  • Winthrop University Hospital
  • Clarkstown Pediatric Associates
  • CPMC Research Pharmacy
  • Elmwood Pediatrics
  • University Rochester Medical Center
  • Northeast Pediatrics and Adolescent Medicine
  • Boone Pediatric Center
  • University of North Carolina Department of Pediatrics
  • Purcell Clinic
  • North Carolina Clinical Research
  • Sylva Pediatrics Associates
  • Ford, Simpson, Lively and Rice Pediatrics
  • Odyssey Research
  • Dakota Clinic/Innovis Health
  • Cincinnati Children's Hospital Medical Center
  • Pediatric Associates of Mt. Carmel
  • Ohio Pediatrics
  • Shelly Senders and Associates
  • Grand Prairie Pediatric and Allergy Clinic
  • Hillcrest Medical Group/Utica Park Clinic
  • Children's Hospital of Pittsburgh
  • Allegheny General Hospital
  • Primary Physicians Research Inc.
  • Asthma & Allergy Research Associates
  • East Bay Pediatrics
  • Omega Medical Research
  • Medical University of South Carolina
  • Northridge Brown Clinic
  • Medsouth Healthcare
  • Holston Medical Group Pediatrics
  • Murfressboro Medical Clinic
  • Pediatric Clincal Research Office
  • Wells Branch Medical Center
  • Sadler Clinic/Healthsouth Clinical Research
  • Pediatric Allergy/Immunology Associates, PA
  • Healthfirst Medical Group
  • Med-Pro Research Inc.
  • Scott and White/Pediatric Clinic
  • Rd Clinical Research Inc.
  • Central Texas Health Research
  • Benchmark Research
  • Quality Assurance Research Center
  • Wee Care Pediatrics
  • Cottonwood Pediatrics
  • Bear Care Pediatrics
  • Alpine Pediatrics
  • Utah Valley Pediatrics
  • J. Lewis Research Inc.
  • J. Lewis Research, Inc.
  • Families First Pediatrics
  • J. Lewis Research/Southwest Family Medicine
  • PI-Coor Clinical Research, LLC
  • Respiratory Disease Study Unit
  • Health Research of Hampton Roads, Inc
  • Center for Pediatric Research
  • VCU Campus Children's Pavilion/Pediatric Clinical Trials Office
  • Advanced Pediatrics
  • Univeristy Pediatrics
  • Monroe Medical Foundation
  • Sint-Vincentiusziekenhuis Sint-Vincentiusstraat
  • Private Practice
  • UVC Brugmann
  • AZ-VUB Paediatric Clinic
  • Private Practice
  • KUL Dienst Jeugdgezondheidszorg
  • Private Practice
  • Private Practice
  • Private Practice
  • IN Boskovice a. s. Detské oddelení
  • In Boskovice a.s. Detske oddeleni
  • Privantni praxe praktickenho
  • Privátní praxe praktického lékare pro deti a dorost Lysice
  • Nemocnice s poliklinikou v Moste
  • STOPED s.r.o.
  • Department of Pediatrics
  • Department of Pediatrics/Adolescent Medicine
  • Department of Pediatrics - Paediatrics Unit
  • Department of Pediatrics/Adolescent Medicine
  • Department of Pediactrics
  • Springhill Surgery
  • Randalstown Health Centre
  • Nottinghill Practice, Whiteabbey Health Centre
  • Department of Pediatrics
  • Dept. of Pediatrics
  • Department of Pediatrics
  • Department of Pediatrics
  • Department of Pediatrics
  • Department of Pediatrics
  • Department of Pediatrics
  • Department of Pediatrics
  • Department of Pediatrics
  • Ashville Medical Center
  • Townhead Surgery
  • Cathcart Street Practice
  • Stonehill Medical Centre
  • The Orchard Medical Centre
  • The Staploe Medical Centre
  • Avondale Surgery Research
  • Saltash Health Centre
  • Woodend Health Centre
  • Gabels Medical Centre
  • Govind Health Cenre
  • Woolwell Medical Centre
  • The Medical Centre
  • Valleyfield Health Centre
  • Castlemilk Health Centre
  • Kingsway Medical
  • Layton Medical Centre
  • Greenwood & Sneinton Family Medical Practice
  • Landsdowne Road Yaxley
  • Knowle House Surgery
  • Wansford Surgery
  • Sherbourne Medical Centre

Outcomes

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

Full Information

First Posted
August 5, 2005
Last Updated
September 10, 2021
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00128167
Brief Title
Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
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 Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
8500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Liquid CAIV-T
Primary Outcome Measure Information:
Title
The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
Title
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
Title
influenza surveillance period and at least 14 days after the last required vaccination
Secondary Outcome Measure Information:
Title
Culture-confirmed symptomatic influenza infection regardless of antigenic match
Title
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
Title
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
Title
Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and
Title
Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Walker, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Consultants, Inc
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
Facility Name
Little Rock Allergy and Asthma Clinical
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Friendly Care Medical Group
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Family Medical Center
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Edinger Mecial Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-7504
Country
United States
Facility Name
Fresno Childrens Medical Group, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Heathcare Partners Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Kaiser Permanente Vaccine Study Center
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
PRA Trials
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Benchmark Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Convenience Care
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Norwich Pediatric Group, PC
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Clinical Research Care & Resource Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Pediatric Research Center of South Florida
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pediatrics and Adolescent Medicine, P.A.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Facility Name
Medical Parameters
City
Martinez
State/Province
Georgia
ZIP/Postal Code
30907
Country
United States
Facility Name
Rush University Medical Center/University Consultatnts in Allergy and Immunology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Heart of America Research Institute
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Heart of America Research Institute-Topeka
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Kentucky Pediatrics/Adult Research Inc.
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
University Child Health Specialists, PCTU
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Clinical Trials Management, LLC/The Pediatric Clinic
City
Bogalusa
State/Province
Louisiana
ZIP/Postal Code
70427
Country
United States
Facility Name
Dolby Providers LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70128
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Woburn Pediatric Associates
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
Facility Name
Odyssey Research
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Chidren's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Center for Vaccine Development
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bozeman Urgent Care Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Creighton/UNMC Pediatric Infectious Disease
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Henderson Pediatrics
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89015
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Summit Pediatric Pulmonary
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
United Medical Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Barbara Dzierzek/PharmaTrials, Inc.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11222
Country
United States
Facility Name
Health Sciences Research Center
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Endwell Family Physicians
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Clarkstown Pediatric Associates
City
Nanuet
State/Province
New York
ZIP/Postal Code
10954
Country
United States
Facility Name
CPMC Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Elmwood Pediatrics
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Northeast Pediatrics and Adolescent Medicine
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Boone Pediatric Center
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
University of North Carolina Department of Pediatrics
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
79599
Country
United States
Facility Name
Purcell Clinic
City
Laurinburg
State/Province
North Carolina
ZIP/Postal Code
28352
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Sylva Pediatrics Associates
City
Sylva
State/Province
North Carolina
ZIP/Postal Code
28779
Country
United States
Facility Name
Ford, Simpson, Lively and Rice Pediatrics
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Odyssey Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Dakota Clinic/Innovis Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Pediatric Associates of Mt. Carmel
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Ohio Pediatrics
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Shelly Senders and Associates
City
University Heights
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Grand Prairie Pediatric and Allergy Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73132
Country
United States
Facility Name
Hillcrest Medical Group/Utica Park Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15123
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Primary Physicians Research Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241-3100
Country
United States
Facility Name
Asthma & Allergy Research Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
East Bay Pediatrics
City
Barrington
State/Province
Rhode Island
ZIP/Postal Code
02806
Country
United States
Facility Name
Omega Medical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Northridge Brown Clinic
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Medsouth Healthcare
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
Facility Name
Holston Medical Group Pediatrics
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Murfressboro Medical Clinic
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Pediatric Clincal Research Office
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2573
Country
United States
Facility Name
Wells Branch Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78728
Country
United States
Facility Name
Sadler Clinic/Healthsouth Clinical Research
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Pediatric Allergy/Immunology Associates, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Healthfirst Medical Group
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Med-Pro Research Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Scott and White/Pediatric Clinic
City
Killeen
State/Province
Texas
ZIP/Postal Code
76451
Country
United States
Facility Name
Rd Clinical Research Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Quality Assurance Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Cottonwood Pediatrics
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Bear Care Pediatrics
City
Ogden
State/Province
Utah
ZIP/Postal Code
84450
Country
United States
Facility Name
Alpine Pediatrics
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Utah Valley Pediatrics
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
J. Lewis Research Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Families First Pediatrics
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
J. Lewis Research/Southwest Family Medicine
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84084
Country
United States
Facility Name
PI-Coor Clinical Research, LLC
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Respiratory Disease Study Unit
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Health Research of Hampton Roads, Inc
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Center for Pediatric Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
VCU Campus Children's Pavilion/Pediatric Clinical Trials Office
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Advanced Pediatrics
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180-4224
Country
United States
Facility Name
Univeristy Pediatrics
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Monroe Medical Foundation
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States
Facility Name
Sint-Vincentiusziekenhuis Sint-Vincentiusstraat
City
Antwerp
ZIP/Postal Code
2018
Country
Belgium
Facility Name
Private Practice
City
Berchem
ZIP/Postal Code
2600
Country
Belgium
Facility Name
UVC Brugmann
City
Brussel
ZIP/Postal Code
1030
Country
Belgium
Facility Name
AZ-VUB Paediatric Clinic
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Private Practice
City
Drongen
ZIP/Postal Code
9031
Country
Belgium
Facility Name
KUL Dienst Jeugdgezondheidszorg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Private Practice
City
Schoten
ZIP/Postal Code
2900
Country
Belgium
Facility Name
Private Practice
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Private Practice
City
Wondelgem
ZIP/Postal Code
9032
Country
Belgium
Facility Name
IN Boskovice a. s. Detské oddelení
City
Boskovice
ZIP/Postal Code
680 21
Country
Czechia
Facility Name
In Boskovice a.s. Detske oddeleni
City
Boskovice
ZIP/Postal Code
680 21
Country
Czechia
Facility Name
Privantni praxe praktickenho
City
Lysice
ZIP/Postal Code
679 71
Country
Czechia
Facility Name
Privátní praxe praktického lékare pro deti a dorost Lysice
City
Lysice
ZIP/Postal Code
679 71
Country
Czechia
Facility Name
Nemocnice s poliklinikou v Moste
City
Most
ZIP/Postal Code
434 64
Country
Czechia
Facility Name
STOPED s.r.o.
City
Plzen
ZIP/Postal Code
301 66
Country
Czechia
Facility Name
Department of Pediatrics
City
Chai Wan
Country
Hong Kong
Facility Name
Department of Pediatrics/Adolescent Medicine
City
Hang Hau
Country
Hong Kong
Facility Name
Department of Pediatrics - Paediatrics Unit
City
Kowloon
Country
Hong Kong
Facility Name
Department of Pediatrics/Adolescent Medicine
City
Lai Chi Kok
Country
Hong Kong
Facility Name
Department of Pediactrics
City
Shatin
Country
Hong Kong
Facility Name
Springhill Surgery
City
Bangor County
ZIP/Postal Code
BT 19 1PP
Country
Ireland
Facility Name
Randalstown Health Centre
City
Randalsotown
ZIP/Postal Code
BT413AE
Country
Ireland
Facility Name
Nottinghill Practice, Whiteabbey Health Centre
City
Whiteabbey
ZIP/Postal Code
BT37 9QN
Country
Ireland
Facility Name
Department of Pediatrics
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Dept. of Pediatrics
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Department of Pediatrics
City
Seoul
ZIP/Postal Code
135-230
Country
Korea, Republic of
Facility Name
Department of Pediatrics
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Department of Pediatrics
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Department of Pediatrics
City
Taichung
ZIP/Postal Code
403
Country
Taiwan
Facility Name
Department of Pediatrics
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Department of Pediatrics
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Department of Pediatrics
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ashville Medical Center
City
Barnsely
State/Province
South Yorks
ZIP/Postal Code
S703RJ
Country
United Kingdom
Facility Name
Townhead Surgery
City
Ayrshire
ZIP/Postal Code
KA12 0AY
Country
United Kingdom
Facility Name
Cathcart Street Practice
City
Ayr
ZIP/Postal Code
KA71BJ
Country
United Kingdom
Facility Name
Stonehill Medical Centre
City
Bolton
ZIP/Postal Code
BL49Q2
Country
United Kingdom
Facility Name
The Orchard Medical Centre
City
Bristol
ZIP/Postal Code
BS15 2NJ
Country
United Kingdom
Facility Name
The Staploe Medical Centre
City
Cambs
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Avondale Surgery Research
City
Chesterfield
ZIP/Postal Code
S404TF
Country
United Kingdom
Facility Name
Saltash Health Centre
City
Cornwall
ZIP/Postal Code
PL12 4BU
Country
United Kingdom
Facility Name
Woodend Health Centre
City
Coventry
ZIP/Postal Code
CV2 1XA
Country
United Kingdom
Facility Name
Gabels Medical Centre
City
Coventry
ZIP/Postal Code
CV6 4DD
Country
United Kingdom
Facility Name
Govind Health Cenre
City
Coventry
ZIP/Postal Code
Cv66 4DD
Country
United Kingdom
Facility Name
Woolwell Medical Centre
City
Devon Plymouth
Country
United Kingdom
Facility Name
The Medical Centre
City
East Horley
ZIP/Postal Code
KT246QT
Country
United Kingdom
Facility Name
Valleyfield Health Centre
City
Fife
ZIP/Postal Code
KY128SJ
Country
United Kingdom
Facility Name
Castlemilk Health Centre
City
Glasgow
ZIP/Postal Code
G459AW
Country
United Kingdom
Facility Name
Kingsway Medical
City
Glasgow
Country
United Kingdom
Facility Name
Layton Medical Centre
City
Lancs
ZIP/Postal Code
FY37EN
Country
United Kingdom
Facility Name
Greenwood & Sneinton Family Medical Practice
City
Nottingham
ZIP/Postal Code
NG37DQ
Country
United Kingdom
Facility Name
Landsdowne Road Yaxley
City
Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
Knowle House Surgery
City
Plymouth
ZIP/Postal Code
PL5 3JD
Country
United Kingdom
Facility Name
Wansford Surgery
City
Wansford
ZIP/Postal Code
PE86LP
Country
United Kingdom
Facility Name
Sherbourne Medical Centre
City
Warwick Shire
ZIP/Postal Code
CV324RA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17301299
Citation
Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M, Kemble G, Connor EM; CAIV-T Comparative Efficacy Study Group. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007 Feb 15;356(7):685-96. doi: 10.1056/NEJMoa065368. Erratum In: N Engl J Med. 2007 Mar 22;356(12):1283.
Results Reference
derived

Learn more about this trial

Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

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