Trial Outcomes & Findings for T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011 (NCT NCT03022422)

NCT ID: NCT03022422

Last Updated: 2017-08-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

Day 0

Results posted on

2017-08-21

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 (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group C: 18-30 yo Fraternal Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group D: 40-64 yo Identical Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group E: 40-64 yo Fraternal Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (TIV) Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (High-Dose TIV) Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
Overall Study STARTED	8	10	23	12	5	5
Overall Study COMPLETED	8	10	20	12	5	5
Overall Study NOT COMPLETED	0	0	3	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group B: 18-30 yo Identical Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group C: 18-30 yo Fraternal Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group D: 40-64 yo Identical Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group E: 40-64 yo Fraternal Twins (TIV) Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (TIV) Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (High-Dose TIV) Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
Overall Study 3 subjects consented but not vaccinated	0	0	3	0	0	0

Baseline Characteristics

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group B: 18-30 yo Identical Twins (TIV) n=8 Participants Individual twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group C: 18-30 yo Fraternal Twins (TIV) n=10 Participants Individual twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group D: 40-64 yo Identical Twins (TIV) n=23 Participants Individual twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group E: 40-64 yo Fraternal Twins (TIV) n=12 Participants Individual twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (TIV) n=5 Participants Individual twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (High-DoseTIV) n=5 Participants Individual twins will receive Fluzone® high-dose TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection	Total n=63 Participants Total of all reporting groups
Age, Continuous	24.79 years STANDARD_DEVIATION 4.18 • n=93 Participants	26.37 years STANDARD_DEVIATION 3.11 • n=4 Participants	50.55 years STANDARD_DEVIATION 7.03 • n=27 Participants	55.86 years STANDARD_DEVIATION 7.10 • n=483 Participants	70.08 years STANDARD_DEVIATION 3.83 • n=36 Participants	70.08 years STANDARD_DEVIATION 3.83 • n=10 Participants	47.55 years STANDARD_DEVIATION 16.46 • n=115 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants	7 Participants n=483 Participants	3 Participants n=36 Participants	3 Participants n=10 Participants	42 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants	5 Participants n=483 Participants	2 Participants n=36 Participants	2 Participants n=10 Participants	21 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	9 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants	8 Participants n=4 Participants	20 Participants n=27 Participants	10 Participants n=483 Participants	5 Participants n=36 Participants	5 Participants n=10 Participants	53 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	8 Participants n=4 Participants	20 Participants n=27 Participants	9 Participants n=483 Participants	5 Participants n=36 Participants	5 Participants n=10 Participants	53 Participants n=115 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Region of Enrollment United States	8 participants n=93 Participants	10 participants n=4 Participants	23 participants n=27 Participants	12 participants n=483 Participants	5 participants n=36 Participants	5 participants n=10 Participants	63 participants n=115 Participants

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Outcome measures
Measure	Group B: 18-30 yo Identical Twins (TIV) n=8 Participants Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group C: 18-30 yo Fraternal Twins (TIV) n=10 Participants Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group D: 40-64 yo Identical Twins (TIV) n=20 Participants Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group E: 40-64 yo Fraternal Twins (TIV) n=12 Participants Individual Twins to receive Fluzone® standard TIV Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (TIV) n=5 Participants Individual Twins will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection	Group F: 65-100 yo Identical Twins (High-DoseTIV) n=5 Participants Individual Twins will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
Number of Individual Twins Who Received Influenza Vaccine	8 Participants	10 Participants	20 Participants	12 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 0 to 28 post-immunization