Trial Outcomes & Findings for Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031) (NCT NCT03028987)

Results Overview

Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Day 0

Results posted on

2017-09-12

Participant Flow

Volunteers are past participants who are identical twins and who have been identified as HLA DR1501+ or DR0701+ by lab assay results.

All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .

Participant milestones

Participant milestones
Measure	LAIV Randomized Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).	IIV4 Randomized Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LAIV Randomized n=5 Participants Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)	IIV4 Randomized n=5 Participants Individual twins are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	46 years STANDARD_DEVIATION 9.79 • n=99 Participants	46 years STANDARD_DEVIATION 9.79 • n=107 Participants	46 years STANDARD_DEVIATION 9.23 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	5 participants n=99 Participants	5 participants n=107 Participants	10 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 0

Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment

Outcome measures

Outcome measures
Measure	LAIV Randomized n=5 Participants Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).	IIV4 Randomized n=5 Participants Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
Number of Participants Who Received Influenza Vaccine	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 0 to 28 post-immunization

Number of individual twins who experienced related adverse events through the course of the study.

Outcome measures

Outcome measures
Measure	LAIV Randomized n=5 Participants Individual twins in this group received FluMist®: FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine).	IIV4 Randomized n=5 Participants Individual twins in this group received Fluzone®: Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine).
Number of Participants With Related Adverse Events	0 Participants	0 Participants

Adverse Events

LAIV Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IIV4 Randomized

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

Cornelia Dekker, MD

Stanford University School of Medicine, Dept. of Pediatrics

Phone: 6507244437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place