Trial Outcomes & Findings for Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal (NCT NCT01854632)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1761 participants

Primary outcome timeframe

Through 7 to 8 months post vaccination

Results posted on

2015-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccine Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010	Placebo Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Overall Study STARTED	1174	587
Overall Study COMPLETED	1148	574
Overall Study NOT COMPLETED	26	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine n=1174 Participants Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010	Placebo n=587 Participants Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.	Total n=1761 Participants Total of all reporting groups
Age, Categorical <=18 years	1174 Participants n=5 Participants	587 Participants n=7 Participants	1761 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	564 Participants n=5 Participants	290 Participants n=7 Participants	854 Participants n=5 Participants
Sex: Female, Male Male	610 Participants n=5 Participants	297 Participants n=7 Participants	907 Participants n=5 Participants
Region of Enrollment Senegal	1174 participants n=5 Participants	587 participants n=7 Participants	1761 participants n=5 Participants

PRIMARY outcome

Timeframe: Through 7 to 8 months post vaccination

Population: All participants meeting per-protocol analysis criteria.

Outcome measures

Outcome measures
Measure	Vaccine n=1173 Participants Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010	Placebo n=584 Participants Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)	17.9 percentage of participants	18.0 percentage of participants

SECONDARY outcome

Timeframe: Through 30 minutes post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 7 days post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 1 month post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 1 month post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 7 to 8 months post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 7 to 8 months post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 7 to 8 months post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 7 to 8 months post vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 7 to 8 months post vaccination

Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 4 days post vaccination

Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.

Outcome measures

Outcome data not reported

Adverse Events

Vaccine

Serious events: 7 serious events

Other events: 56 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vaccine n=1174 participants at risk Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010	Placebo n=587 participants at risk Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Injury, poisoning and procedural complications Trauma	0.09% 1/1174 • Number of events 1 • Throughout the study period: May through December 2013	0.85% 5/587 • Number of events 5 • Throughout the study period: May through December 2013
Respiratory, thoracic and mediastinal disorders Respiratory illnesses	0.17% 2/1174 • Number of events 2 • Throughout the study period: May through December 2013	0.34% 2/587 • Number of events 2 • Throughout the study period: May through December 2013
General disorders Other	0.34% 4/1174 • Number of events 4 • Throughout the study period: May through December 2013	0.00% 0/587 • Throughout the study period: May through December 2013

Other adverse events

Other adverse events
Measure	Vaccine n=1174 participants at risk Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010	Placebo n=587 participants at risk Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Respiratory, thoracic and mediastinal disorders Respiratory AEs	1.4% 17/1174 • Throughout the study period: May through December 2013	2.7% 16/587 • Throughout the study period: May through December 2013
General disorders Non Respiratory AEs	3.3% 39/1174 • Throughout the study period: May through December 2013	2.9% 17/587 • Throughout the study period: May through December 2013

Additional Information

Senior Clinical Research Scientist

PATH

Phone: 206-285-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60