Trial Outcomes & Findings for The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets (NCT NCT03898986)

Last Updated: 2025-03-06

Results Overview

Evaluate HAI titers in response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Day 28

Results posted on

2025-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Inactivated Influenza Vaccine (IIV) Participants were randomized to received IIV	Live Attenuated Influenza Vaccine 4 (LAIV 4) The other twin set was randomized to the LAIV
Overall Study STARTED	9	9
Overall Study Identical Twin	2	2
Overall Study Fraternal Twin	7	7
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inactivated Influenza Vaccine (IIV) n=9 Participants Participants were randomized to received IIV	Live Attenuated Influenza Vaccine 4 (LAIV 4) n=9 Participants The other twin set was randomized to the LAIV4	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Inactivated Influenza Vaccine (IIV)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Live Attenuated Influenza Vaccine 4 (LAIV 4)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Grant, MD

Stanford University

Phone: 6507239001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place