Trial Outcomes & Findings for T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013 (NCT NCT03023176)

Last Updated: 2017-04-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Day 0 to 32

Results posted on

2017-04-21

Participant milestones
Measure	Healthy 1-8 Year-old Twins 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 Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Healthy 1-8 Year-old Twins n=20 Participants 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
Age, Continuous	4.06 years STANDARD_DEVIATION 1.46 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

Timeframe: Day 0 to 32

Outcome measures
Measure	Healthy 1-8 Year-old Twins n=20 Participants 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
Number of Participants Who Received Influenza Vaccine	20 Participants

Timeframe: Day 0 to 32 post-immunization

Outcome measures
Measure	Healthy 1-8 Year-old Twins n=20 Participants 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
Number of Participants With Related Adverse Events	0 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Stanford University School of Medicine, Dept. of Pediatrics

Phone: 650-724-4437