Trial · NCT01797029

A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh

NCT01797029, Phase 3, Completed, PATH; results first posted 2015-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh. Trials, record NCT01797029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01797029

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
NCT number: NCT01797029
Status: Completed
Phases: Phase 3
Enrollment: 1,761 participants, actual
Lead sponsor: PATH
Conditions: Influenza
Interventions: SIIL Live Attenuated Influenza Vaccine, Placebo
First posted: 2013-02-22
Last updated: 2015-06-11
Results first posted: 2015-05-15

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).	Through 7 to 9 months post-vaccination
Secondary	Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions	Through one week post-vaccination
Secondary	Safety Profile of LAIV: Immediate Reactions	30 minutes post-vaccination
Secondary	Safety Profile of LAIV: Serious Adverse Events	Through 7 to 9 months post-vaccination
Secondary	Safety Profile of LAIV: Protocol Defined Wheezing Illness	Through 7 to 9 months post-vaccination
Secondary	Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)	Through 7 to 9 months post-vaccination
Secondary	The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens	Through 16 to 19 months post-vaccination
Secondary	The Viral Etiologies of Acute Respiratory and Febrile Illness	Through 16 to 19 months post-vaccination
Secondary	Safety Profile of LAIV: Serious Adverse Events	Through 16 to 19 months post-vaccination
Secondary	Safety Profile of LAIV: Protocol Defined Wheezing Illness	Through 16 to 19 months post-vaccination

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).	Through 7 to 9 months post-vaccination	percentage of participants	NUMBER
SECONDARY	Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions	Through one week post-vaccination
SECONDARY	Safety Profile of LAIV: Immediate Reactions	30 minutes post-vaccination	participants	NUMBER
SECONDARY	Safety Profile of LAIV: Serious Adverse Events	Through 7 to 9 months post-vaccination
SECONDARY	Safety Profile of LAIV: Protocol Defined Wheezing Illness	Through 7 to 9 months post-vaccination
SECONDARY	Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)	Through 7 to 9 months post-vaccination
SECONDARY	The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens	Through 16 to 19 months post-vaccination
SECONDARY	The Viral Etiologies of Acute Respiratory and Febrile Illness	Through 16 to 19 months post-vaccination
SECONDARY	Safety Profile of LAIV: Serious Adverse Events	Through 16 to 19 months post-vaccination
SECONDARY	Safety Profile of LAIV: Protocol Defined Wheezing Illness	Through 16 to 19 months post-vaccination

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).	Vaccine	6.7	percentage of participants
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).	Placebo	15.8	percentage of participants
Safety Profile of LAIV: Immediate Reactions	Vaccine	0	participants
Safety Profile of LAIV: Immediate Reactions	Placebo	0	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vaccine	1,174
Overall Study	STARTED	Placebo	587
Overall Study	COMPLETED	Vaccine	1,015
Overall Study	COMPLETED	Placebo	526
Overall Study	NOT COMPLETED	Vaccine	159
Overall Study	NOT COMPLETED	Placebo	61

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Any SOC	General disorders	Vaccine	68	1,174
other	Any SOC	General disorders	Placebo	35	587
serious	Respiratory SAEs	Respiratory, thoracic and mediastinal disorders	Vaccine	11	1,174	11
serious	Respiratory SAEs	Respiratory, thoracic and mediastinal disorders	Placebo	8	587	8
serious	Non respiratory SAEs	General disorders	Vaccine	31	1,174	31
serious	Non respiratory SAEs	General disorders	Placebo	11	587	11

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vaccine
Total, all-cause mortality	Placebo
Total, other adverse events	Vaccine	68	1,174
Total, other adverse events	Placebo	35	587
Total, serious adverse events	Vaccine	42	1,174
Total, serious adverse events	Placebo	19	587

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27746226	DERIVED	PubMed
29028980	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vaccine vs Placebo: Safety Profile of LAIV: Immediate Reactions	Trial comparisons
Vaccine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01797029

GET https://conductscience.org/api/trials/v1/NCT01797029/registered

API reference For AI assistants