Trial Outcomes & Findings for Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children (NCT NCT03735147)

Results Overview

No of participants with viral shedding on day 1 following LAIV vaccination

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Assessed on day 1 post LAIV

Results posted on

2024-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	All Children Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed on day 1 post LAIV

No of participants with viral shedding on day 1 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 1 Post LAIV	3 Participants

PRIMARY outcome

Timeframe: Assessed on day 2 post LAIV

No of participants with viral shedding on day 2 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 2 Post LAIV	3 Participants

PRIMARY outcome

Timeframe: Assessed on day 3 post LAIV

No of participants with viral shedding on day 3 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 3 Post LAIV	1 Participants

PRIMARY outcome

Timeframe: Assessed on day 4 post LAIV

No of participants with viral shedding on day 4 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 4 Post LAIV	3 Participants

PRIMARY outcome

Timeframe: Assessed on day 5 post LAIV

No of participants with viral shedding on day 5 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 5 Post LAIV	3 Participants

PRIMARY outcome

Timeframe: Assessed on day 6 post LAIV

No of participants with viral shedding on day 6 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 6 Post LAIV	3 Participants

PRIMARY outcome

Timeframe: Assessed on day 7 post LAIV

No of participants with viral shedding on day 7 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 7 Post LAIV	2 Participants

PRIMARY outcome

Timeframe: Assessed on day 8 post LAIV

No of participants with viral shedding on day 8 following LAIV vaccination

Outcome measures

Outcome measures
Measure	All Children n=12 Participants Administration of live attenuated influenza vaccine (LAIV) Live attenuated influenza vaccine (LAIV): Single dose of LAIV
Type-specific Vaccine Virus Shedding in 2018/19 - Day 8 Post LAIV	2 Participants

Adverse Events

All Children

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

Dr Paul Turner

Imperial College London

Phone: +44 20 3312 7754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place