Trial Outcomes & Findings for T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012 (NCT NCT03022435)

NCT ID: NCT03022435

Last Updated: 2017-05-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

Day 0

Results posted on

2017-05-22

Participant Flow

Numbers listed in the tables reflect individual twins and not twin pairs.

Participant milestones

Participant milestones
Measure	Group B: 18-30 yo Identical Twins (LAIV) Participants to receive FluMist® LAIV by nasal spray.	Group B: 18-30 yo Identical Twins (TIV) Participants to receive Fluzone® standard TIV	Group D: 40 - 64 yo Identical Twins Participants to receive Fluzone® standard TIV	Group F: 65-100 yo Identical Twins (TIV) Participants to receive Fluzone® standard TIV	Group F: 65-100 yo Identical Twins (High-Dose TIV) Participants to receive High-Dose Fluzone® standard TIV
Overall Study STARTED	5	5	6	3	3
Overall Study COMPLETED	5	5	6	3	3
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group B: 18-30 yo Identical Twins (LAIV) n=5 Participants Participants to receive FluMist® LAIV by nasal spray.	Group B: 18-30 yo Identical Twins (TIV) n=5 Participants Participants to receive Fluzone® standard TIV	Group D: 40 - 64 yo Identical Twins (TIV) n=6 Participants Participants to receive Fluzone® standard TIV	Group F: 65 - 100 yo Identical Twins (TIV) n=3 Participants Participants to receive Fluzone® standard TIV	Group F: 65 - 100 yo Identical Twins (High-Dose TIV) n=3 Participants Participants to receive High-Dose Fluzone® standard TIV	Total n=22 Participants Total of all reporting groups
Age, Continuous	22.98 years STANDARD_DEVIATION 4.26 • n=5 Participants	22.98 years STANDARD_DEVIATION 4.26 • n=7 Participants	42.76 years STANDARD_DEVIATION 1.93 • n=5 Participants	73.45 years STANDARD_DEVIATION 4.20 • n=4 Participants	73.45 years STANDARD_DEVIATION 4.20 • n=21 Participants	42.14 years STANDARD_DEVIATION 21.63 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	16 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	22 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Outcome measures
Measure	Group B: 18-30 yo Identical Twins (LAIV) n=5 Participants Participants to receive FluMist® LAIV by nasal spray.	Group B: 18-30 yo Identical Twins (TIV) n=5 Participants Participants to receive Fluzone® standard TIV	Group D: 40 - 64 yo Identical Twins (TIV) n=6 Participants Participants to receive Fluzone® standard TIV	Group F: 65 - 100 yo Identical Twins (TIV) n=3 Participants Participants to receive Fluzone® standard TIV	Group F: 65 - 100 yo Identical Twins (High-Dose TIV) n=3 Participants Participants to receive High-Dose Fluzone® standard TIV
Number of Participants Who Received Influenza Vaccine	5 Participants	5 Participants	6 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 0 to 28 post-immunization