Trial Outcomes & Findings for Efficacy & Safety of Nasal Influenza Immunisation in Children (NCT NCT02549365)

Results Overview

Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

276 participants

Primary outcome timeframe

During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months

Results posted on

2019-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season	Controls Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season
Overall Study STARTED	164	112
Overall Study COMPLETED	164	112
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=164 Participants Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season	Controls n=112 Participants Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season	Total n=276 Participants Total of all reporting groups
Age, Categorical <=18 years	164 Participants n=164 Participants	112 Participants n=112 Participants	276 Participants n=276 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=164 Participants	0 Participants n=112 Participants	0 Participants n=276 Participants
Age, Categorical >=65 years	0 Participants n=164 Participants	0 Participants n=112 Participants	0 Participants n=276 Participants
Sex: Female, Male Female	65 Participants n=164 Participants	48 Participants n=112 Participants	113 Participants n=276 Participants
Sex: Female, Male Male	99 Participants n=164 Participants	64 Participants n=112 Participants	163 Participants n=276 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	164 Participants n=164 Participants	112 Participants n=112 Participants	276 Participants n=276 Participants

PRIMARY outcome

Timeframe: During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months

Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls

Outcome measures

Outcome measures
Measure	Intervention n=164 Participants Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season	Controls n=112 Participants Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season
Vaccine Efficacy Swab negative	21 Participants	15 Participants
Vaccine Efficacy No swab taken as not indicated	135 Participants	95 Participants
Vaccine Efficacy Swab positive for H1N1	4 Participants	2 Participants
Vaccine Efficacy Swab positive for 'flu B	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks following administration of a single dose of LAIV

Population: 39 patients provided paired blood samples pre and post LAIV 89 patients provided paired oral fluid samples pre/post LAIV

To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses

Outcome measures

Outcome measures
Measure	Intervention n=89 Participants Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season	Controls Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season
Immune Response to LAIV >4-fold increase in HI titre to a_cal strain	1 Participants	—
Immune Response to LAIV >4-fold increase in HI titre to a_swiss strain	19 Participants	—
Immune Response to LAIV >4-fold increase in HI titre to a_eng strain	4 Participants	—
Immune Response to LAIV >4-fold increase in HI titre to b_phu strain	9 Participants	—
Immune Response to LAIV >4-fold increase in HI titre to b_bris strain	11 Participants	—
Immune Response to LAIV >4-fold increase in oral fluid IgA to h1	6 Participants	—
Immune Response to LAIV >4-fold increase in oral fluid IgA to h3	19 Participants	—

SECONDARY outcome

Timeframe: Up to 1 month after LAIV administration

Population: AE data was not collected in household controls, as per protocol

Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses: * AEs occurring up to 72 hours after LAIV in participants with a history of atopy / asthma / recurrent wheezing, compared to non-atopic participants. * Wheezing / asthma symptoms in subjects given LAIV who have a past medical history of asthma or recurrent wheeze in the 4 weeks prior to vaccine administration vs the 3-4 week period after LAIV. NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol)

Outcome measures

Outcome measures
Measure	Intervention n=164 Participants Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season	Controls Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV AE	63 Participants	—
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV No AEFI reported	101 Participants	—
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV SAE	0 Participants	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=164 participants at risk Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season NB: Adverse Events were not monitored/assessed for the Household "Controls"
Respiratory, thoracic and mediastinal disorders Rhinitis	16.5% 27/164 • Number of events 27
Respiratory, thoracic and mediastinal disorders Viral upper respiratory tract infection	9.8% 16/164 • Number of events 16

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