Trial Outcomes & Findings for A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh (NCT NCT01797029)
NCT ID: NCT01797029
Last Updated: 2015-06-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1761 participants
Primary outcome timeframe
Through 7 to 9 months post-vaccination
Results posted on
2015-06-11
Participant Flow
Participant milestones
| Measure |
Vaccine
A single dose of Serum Institute of India, Ltd. (SIIL) Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
|
Placebo
Inactive placebo will be identical to reconstituted Serum Institute of India, Ltd. (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
|
1015
|
526
|
|
Overall Study
NOT COMPLETED
|
159
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
Baseline characteristics by cohort
| Measure |
Vaccine
n=1174 Participants
A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
|
Placebo
n=587 Participants
Inactive 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=39 Participants
|
587 Participants
n=41 Participants
|
1761 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
589 Participants
n=39 Participants
|
306 Participants
n=41 Participants
|
895 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
585 Participants
n=39 Participants
|
281 Participants
n=41 Participants
|
866 Participants
n=35 Participants
|
|
Region of Enrollment
Bangladesh
|
1174 participants
n=39 Participants
|
587 participants
n=41 Participants
|
1761 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Through 7 to 9 months post-vaccinationOutcome measures
| Measure |
Vaccine
n=1174 Participants
A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
|
Placebo
n=587 Participants
Inactive 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 (Vaccine-matched Strains).
|
6.7 percentage of participants
|
15.8 percentage of participants
|
SECONDARY outcome
Timeframe: Through one week post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutes post-vaccinationOutcome measures
| Measure |
Vaccine
n=1174 Participants
A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
|
Placebo
n=587 Participants
Inactive 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.
|
|---|---|---|
|
Safety Profile of LAIV: Immediate Reactions
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Through 7 to 9 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 7 to 9 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 7 to 9 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 7 to 9 months post-vaccinationOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 16 to 19 months post-vaccinationOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From approx. 6 months to approximately 19 months post-vaccinationOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From approx. 6 months to approximately 19 months post-vaccinationOutcome measures
Outcome data not reported
Adverse Events
Vaccine
Serious events: 42 serious events
Other events: 68 other events
Deaths: 0 deaths
Placebo
Serious events: 19 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccine
n=1174 participants at risk
A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
|
Placebo
n=587 participants at risk
Inactive 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 SAEs
|
0.94%
11/1174 • Number of events 11 • Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Adverse events are classified according to the type of adverse event.
|
1.4%
8/587 • Number of events 8 • Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Adverse events are classified according to the type of adverse event.
|
|
General disorders
Non respiratory SAEs
|
2.6%
31/1174 • Number of events 31 • Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Adverse events are classified according to the type of adverse event.
|
1.9%
11/587 • Number of events 11 • Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Adverse events are classified according to the type of adverse event.
|
Other adverse events
| Measure |
Vaccine
n=1174 participants at risk
A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
|
Placebo
n=587 participants at risk
Inactive 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.
|
|---|---|---|
|
General disorders
Any SOC
|
5.8%
68/1174 • Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Adverse events are classified according to the type of adverse event.
|
6.0%
35/587 • Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Adverse events are classified according to the type of adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60