Trial · NCT01854632
Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
NCT01854632, Phase 3, Completed, PATH; results first posted 2015-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal. Trials, record NCT01854632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01854632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
- NCT number
- NCT01854632
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,761 participants, actual
- Lead sponsor
- PATH
- Conditions
- Influenza
- Interventions
- SIIL Live Attenuated Influenza Vaccine, Matched placebo
- First posted
- 2013-05-15
- Last updated
- 2015-06-03
- Results first posted
- 2015-06-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match) | Through 7 to 8 months post vaccination | |
| Secondary | Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine. | Through 30 minutes post vaccination | |
| Secondary | Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions | Through 7 days post vaccination | |
| Secondary | Safety Profile of LAIV: Serious Adverse Events | Through 1 month post vaccination | |
| Secondary | Safety Profile of LAIV: Other Non-serious Adverse Events | Through 1 month post vaccination | |
| Secondary | Safety Profile of LAIV: Protocol Defined Wheezing Illness | Through 7 to 8 months post vaccination | |
| Secondary | Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) | Through 7 to 8 months post vaccination | |
| Secondary | Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B) | Through 7 to 8 months post vaccination | |
| Secondary | Clinical Characteristics of Influenza in the Study Population | Through 7 to 8 months post vaccination | |
| Secondary | Etiologies of Influenza-like Illness in the Study Population | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match) | Through 7 to 8 months post vaccination | All participants meeting per-protocol analysis criteria. | percentage of participants | NUMBER |
| SECONDARY | Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine. | Through 30 minutes post vaccination | |||
| SECONDARY | Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions | Through 7 days post vaccination | |||
| SECONDARY | Safety Profile of LAIV: Serious Adverse Events | Through 1 month post vaccination | |||
| SECONDARY | Safety Profile of LAIV: Other Non-serious Adverse Events | Through 1 month post vaccination | |||
| SECONDARY | Safety Profile of LAIV: Protocol Defined Wheezing Illness | Through 7 to 8 months post vaccination | |||
| SECONDARY | Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) | Through 7 to 8 months post vaccination | |||
| SECONDARY | Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B) | Through 7 to 8 months post vaccination | |||
| SECONDARY | Clinical Characteristics of Influenza in the Study Population | Through 7 to 8 months post vaccination | |||
| SECONDARY | Etiologies of Influenza-like Illness in the Study Population | Through 7 to 8 months post vaccination |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match) | Vaccine | 17.9 | percentage of participants | ||
| Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match) | Placebo | 18.0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine | 1,174 | |
| Overall Study | STARTED | Placebo | 587 | |
| Overall Study | COMPLETED | Vaccine | 1,148 | |
| Overall Study | COMPLETED | Placebo | 574 | |
| Overall Study | NOT COMPLETED | Vaccine | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 13 |
Source ClinicalTrials.gov
Adverse events10
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 | Respiratory AEs | Respiratory, thoracic and mediastinal disorders | Vaccine | 17 | 1,174 | |
| other | Respiratory AEs | Respiratory, thoracic and mediastinal disorders | Placebo | 16 | 587 | |
| other | Non Respiratory AEs | General disorders | Vaccine | 39 | 1,174 | |
| other | Non Respiratory AEs | General disorders | Placebo | 17 | 587 | |
| serious | Trauma | Injury, poisoning and procedural complications | Vaccine | 1 | 1,174 | 1 |
| serious | Trauma | Injury, poisoning and procedural complications | Placebo | 5 | 587 | 5 |
| serious | Respiratory illnesses | Respiratory, thoracic and mediastinal disorders | Vaccine | 2 | 1,174 | 2 |
| serious | Respiratory illnesses | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 587 | 2 |
| serious | Other | General disorders | Vaccine | 4 | 1,174 | 4 |
| serious | Other | General disorders | Placebo | 0 | 587 | 0 |
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 | 56 | 1,174 |
| Total, other adverse events | Placebo | 33 | 587 |
| Total, serious adverse events | Vaccine | 7 | 1,174 |
| Total, serious adverse events | Placebo | 7 | 587 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27746224 | DERIVED |
Source 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vaccine vs Placebo: serious adverse events |
Source 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.
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/NCT01854632
GET https://conductscience.org/api/trials/v1/NCT01854632/registered