Trial · NCT02649192
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
NCT02649192, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2019-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children. Trials, record NCT02649192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02649192
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
- NCT number
- NCT02649192
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Healthy Participants
- Interventions
- Influenza virus vaccine, Vitamins A and D, Placebo
- First posted
- 2016-01-07
- Last updated
- 2019-10-29
- Results first posted
- 2019-09-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera | Day 56 after vaccination | The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported. |
| Primary | Isotype Ratios on Day 56 | Day 56 after vaccination | Isotype ratios will be summarized with descriptive statistics. |
| Secondary | Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall | Day 56 after vaccination | Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval. The rate difference will be described with point estimate and 95% confidence interval. |
| Secondary | Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening | Day 56 after vaccination | Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval for participants sufficient and insufficient in vitamin A at screening. |
| Secondary | HAI Titers at Day 56 After Vaccination, Overall | Day 56 after vaccination | |
| Secondary | HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening | Day 56 after vaccination |
Source ClinicalTrials.gov
Outcomes6
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 Positive Responses in Virus-specific Antibody in Sera | Day 56 after vaccination | All enrolled subjects who satisfied the inclusion/exclusion criteria were included in the analysis. For the four participants who didn't complete the study, results after one immunization were used. | percentage of participants | NUMBER |
| PRIMARY | Isotype Ratios on Day 56 | Day 56 after vaccination | Subjects with complete isotype data at day 56. Subjects with an undetermined assay result were not included in analyses. In some cases, the limit of detection (LOD) for the assay was reached and that LOD value was used in calculations. | ratio | MEDIAN |
| SECONDARY | Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall | Day 56 after vaccination | Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening | Day 56 after vaccination | Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses. | percentage of participants | NUMBER |
| SECONDARY | HAI Titers at Day 56 After Vaccination, Overall | Day 56 after vaccination | Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses. | titers | MEDIAN |
| SECONDARY | HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening | Day 56 after vaccination | Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses. | titers | MEDIAN |
Source ClinicalTrials.gov
Results by group174
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 Positive Responses in Virus-specific Antibody in Sera | A&D - S1 | 80 | percentage of participants | ||
| Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera | Placebo - S1 | 75 | percentage of participants | ||
| Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera | A&D - S2 | 100 | percentage of participants | ||
| Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera | Placebo - S2 | 100 | percentage of participants | ||
| Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera | A&D - S3 | 100 | percentage of participants | ||
| Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera | Placebo - S3 | 100 | percentage of participants | ||
| Isotype Ratios on Day 56 | A&D-S1 | IgA/IgG1 | 0.4 | Full Range 0.06 to 0.67 | ratio |
| Isotype Ratios on Day 56 | Placebo - S1 | IgA/IgG1 | 0.3 | Full Range 0.22 to 0.5 | ratio |
| Isotype Ratios on Day 56 | A&D - S2 | IgA/IgG1 | 0.3 | Full Range 0.004 to 0.63 | ratio |
| Isotype Ratios on Day 56 | Placebo - S2 | IgA/IgG1 | 0.27 | Full Range 0.13 to 0.47 | ratio |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A&D - S1 | 5 | |
| Overall Study | STARTED | Placebo - S1 | 4 | |
| Overall Study | STARTED | A&D - S2 | 22 | |
| Overall Study | STARTED | Placebo - S2 | 22 | |
| Overall Study | STARTED | A&D - S3 | 12 | |
| Overall Study | STARTED | Placebo - S3 | 14 | |
| Overall Study | Vitamin A Sufficiency (RBP≥22,000 ng/ml) | A&D - S1 | 2 | |
| Overall Study | Vitamin A Sufficiency (RBP≥22,000 ng/ml) | Placebo - S1 | 2 | |
| Overall Study | Vitamin A Sufficiency (RBP≥22,000 ng/ml) | A&D - S2 | 11 | |
| Overall Study | Vitamin A Sufficiency (RBP≥22,000 ng/ml) | Placebo - S2 | 12 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events60
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 | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | A&D-S1 | 0 | 5 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Placebo - S1 | 1 | 4 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | A&D - S2 | 0 | 22 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Placebo - S2 | 0 | 22 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | A&D - S3 | 0 | 12 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Placebo - S3 | 0 | 14 | 0 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | A&D-S1 | 1 | 5 | 1 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo - S1 | 0 | 4 | 0 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | A&D - S2 | 1 | 22 | 1 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo - S2 | 1 | 22 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A&D-S1 | 0 | 5 |
| Total, all-cause mortality | Placebo - S1 | 0 | 4 |
| Total, all-cause mortality | A&D - S2 | 0 | 22 |
| Total, all-cause mortality | Placebo - S2 | 0 | 22 |
| Total, all-cause mortality | A&D - S3 | 0 | 12 |
| Total, all-cause mortality | Placebo - S3 | 0 | 14 |
| Total, other adverse events | A&D-S1 | 5 | 5 |
| Total, other adverse events | Placebo - S1 | 2 | 4 |
| Total, other adverse events | A&D - S2 | 6 | 22 |
| Total, other adverse events | Placebo - S2 | 6 | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02649192
GET https://conductscience.org/api/trials/v1/NCT02649192/results?page=2