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Trial record 58 of 597 for:    Fluzone® | Studies With Results

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013

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ClinicalTrials.gov Identifier: NCT03023176
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : March 9, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Influenza
Interventions Biological: Fluzone® standard IIV3
Biological: Fluzone® standard IIV3 Pediatric Dose
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy 1-8 Year-old Twins
Hide Arm/Group Description

Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.

Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection

Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Healthy 1-8 Year-old Twins
Hide Arm/Group Description

Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.

Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection

Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
4.06  (1.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
18
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
  90.0%
More than one race
2
  10.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Participants Who Received Influenza Vaccine
Hide Description [Not Specified]
Time Frame Day 0 to 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy 1-8 Year-old Twins
Hide Arm/Group Description:

Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.

Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection

Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
2.Secondary Outcome
Title Number of Participants With Related Adverse Events
Hide Description [Not Specified]
Time Frame Day 0 to 32 post-immunization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy 1-8 Year-old Twins
Hide Arm/Group Description:

Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.

Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection

Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Day 0 to 32
Adverse Event Reporting Description Clinical Assessment performed at each visit
 
Arm/Group Title Healthy 1-8 Year-old Twins
Hide Arm/Group Description

Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.

Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection

Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection

All-Cause Mortality
Healthy 1-8 Year-old Twins
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy 1-8 Year-old Twins
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy 1-8 Year-old Twins
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr Cornelia Dekker.
Organization: Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Publications:
Responsible Party: Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier: NCT03023176     History of Changes
Other Study ID Numbers: SU-17219-2013
2U19AI057229-06 ( U.S. NIH Grant/Contract )
First Submitted: January 13, 2017
First Posted: January 18, 2017
Results First Submitted: January 18, 2017
Results First Posted: March 9, 2017
Last Update Posted: April 21, 2017