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Trial record 96 of 597 for:    Fluzone® | Studies With Results

Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

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ClinicalTrials.gov Identifier: NCT01854632
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Collaborators:
Institut de Recherche pour le Developpement
Institut Pasteur de Dakar
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: SIIL Live Attenuated Influenza Vaccine
Biological: Matched placebo
Enrollment 1761

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Period Title: Overall Study
Started 1174 587
Completed 1148 574
Not Completed 26 13
Arm/Group Title Vaccine Placebo Total
Hide Arm/Group Description Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid. Total of all reporting groups
Overall Number of Baseline Participants 1174 587 1761
Hide Baseline Analysis Population Description
All enrolled participants receiving the single dose of study vaccine.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1174 participants 587 participants 1761 participants
<=18 years
1174
 100.0%
587
 100.0%
1761
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1174 participants 587 participants 1761 participants
Female
564
  48.0%
290
  49.4%
854
  48.5%
Male
610
  52.0%
297
  50.6%
907
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Senegal Number Analyzed 1174 participants 587 participants 1761 participants
1174 587 1761
1.Primary Outcome
Title Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)
Hide Description [Not Specified]
Time Frame Through 7 to 8 months post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants meeting per-protocol analysis criteria.
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description:
Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Overall Number of Participants Analyzed 1173 584
Measure Type: Number
Unit of Measure: percentage of participants
17.9 18.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaccine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.
Hide Description [Not Specified]
Time Frame Through 30 minutes post vaccination
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions
Hide Description [Not Specified]
Time Frame Through 7 days post vaccination
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Safety Profile of LAIV: Serious Adverse Events
Hide Description [Not Specified]
Time Frame Through 1 month post vaccination
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Safety Profile of LAIV: Other Non-serious Adverse Events
Hide Description [Not Specified]
Time Frame Through 1 month post vaccination
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Safety Profile of LAIV: Protocol Defined Wheezing Illness
Hide Description [Not Specified]
Time Frame Through 7 to 8 months post vaccination
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)
Hide Description [Not Specified]
Time Frame Through 7 to 8 months post vaccination
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)
Hide Description [Not Specified]
Time Frame Through 7 to 8 months post vaccination
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Clinical Characteristics of Influenza in the Study Population
Hide Description [Not Specified]
Time Frame Through 7 to 8 months post vaccination
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Etiologies of Influenza-like Illness in the Study Population
Hide Description Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.
Time Frame Through 7 to 8 months post vaccination
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection
Hide Description Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.
Time Frame Through 4 days post vaccination
Outcome Measure Data Not Reported
Time Frame Throughout the study period: May through December 2013
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vaccine Placebo
Hide Arm/Group Description Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
All-Cause Mortality
Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/1174 (0.60%)      7/587 (1.19%)    
General disorders     
Other   4/1174 (0.34%)  4 0/587 (0.00%)  0
Injury, poisoning and procedural complications     
Trauma   1/1174 (0.09%)  1 5/587 (0.85%)  5
Respiratory, thoracic and mediastinal disorders     
Respiratory illnesses   2/1174 (0.17%)  2 2/587 (0.34%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/1174 (4.77%)      33/587 (5.62%)    
General disorders     
Non Respiratory AEs   39/1174 (3.32%)  17/587 (2.90%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory AEs   17/1174 (1.45%)  16/587 (2.73%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Clinical Research Scientist
Organization: PATH
Phone: 206-285-3500
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01854632     History of Changes
Other Study ID Numbers: LAIV-SEN-01
First Submitted: May 13, 2013
First Posted: May 15, 2013
Results First Submitted: April 30, 2015
Results First Posted: June 3, 2015
Last Update Posted: June 3, 2015