Trial Outcomes & Findings for B-cell Immunity to Influenza (SLVP017)- Year 5, 2013 (NCT NCT03020537)
NCT ID: NCT03020537
Last Updated: 2018-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Group A: 1 - 2 Years Old
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
Group B: 18-30 Years Old
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
7
|
|
Overall Study
COMPLETED
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
Baseline characteristics by cohort
| Measure |
Group A: 1 - 2 Years Old
n=1 Participants
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
Group B: 18-30 Years Old
n=7 Participants
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.128 years
STANDARD_DEVIATION 0 • n=5 Participants
|
27.29 years
STANDARD_DEVIATION 4.066 • n=7 Participants
|
24.025 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Outcome measures
| Measure |
Group A: 1 - 2 Years Old
n=1 Participants
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
Group B: 18-30 Years Old
n=7 Participants
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
|---|---|---|
|
Number of Participants Who Received Influenza Vaccine
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
Group A: 1 - 2 Years Old
n=1 Participants
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
Group B: 18-30 Years Old
n=7 Participants
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
|---|---|---|
|
Number of Participants With Related Adverse Events
|
1 Participants
|
1 Participants
|
Adverse Events
Group A: 1 - 2 Years Old
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: 18-30 Years Old
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: 1 - 2 Years Old
n=1 participants at risk
Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
Group B: 18-30 Years Old
n=7 participants at risk
Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
|
|---|---|---|
|
General disorders
Erythema at vaccination site 0.5 cm
|
100.0%
1/1 • Number of events 1 • Day 0 to 28 of study participation
Clinical Assessment performed at each visit
|
14.3%
1/7 • Number of events 1 • Day 0 to 28 of study participation
Clinical Assessment performed at each visit
|
|
General disorders
Mild Pruritus at Vaccination site Right Deltoid
|
0.00%
0/1 • Day 0 to 28 of study participation
Clinical Assessment performed at each visit
|
14.3%
1/7 • Number of events 1 • Day 0 to 28 of study participation
Clinical Assessment performed at each visit
|
Additional Information
Dr. Cornelia Dekker
Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place