Trial · NCT02915302
Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
NCT02915302, Phase 4, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2018-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children. Trials, record NCT02915302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02915302
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
- NCT number
- NCT02915302
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,950 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Influenza
- Interventions
- Fluzone Quadrivalent vaccine, No Preservative, Fluzone Quadrivalent vaccine, No Preservative
- First posted
- 2016-09-27
- Last updated
- 2022-03-29
- Results first posted
- 2018-04-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine | Within 7 days after any vaccination | Fever rate was defined as percentage of participants with fever (temperature \>=100.4 degrees Fahrenheit \[38.0 degrees Celsius\]) following vaccination with Fluzone Quadrivalent vaccine. |
| Secondary | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | 28 days post-final vaccination | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. |
| Secondary | Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens | 28 days post-final vaccination | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. SCR was defined as percentage of participants with either a pre-vaccination titer \<10 (1/dil) and a post-final vaccination titer \>=40 (1/dil), or a pre-vaccination titer \>=10 (1/dil) and at least a four-fold increase in post-final vaccination titer. |
Source ClinicalTrials.gov
Outcomes3
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 Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine | Within 7 days after any vaccination | Analysis was performed using the safety analysis set. Here, 'Number of participants analyzed' = those participants with available data for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | 28 days post-final vaccination | Analysis was performed using Per-protocol (PP) analysis set which included participants who received at least 1 dose of study vaccine and had a valid post-vaccination serologic result for at least 1 strain without any protocol deviations. Here, 'Number Analyzed' = those participants with available data for specified categories. | Titers (1/dilutions [dil]) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens | 28 days post-final vaccination | Analysis was performed using the PP analysis set. Here, 'Number Analyzed' = those participants with available data for specified categories. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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 Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine | Fluzone Quadrivalent Vaccine, 0.25-mL | 11.31 | 95% Confidence Interval 9.31 to 13.57 | percentage of participants | |
| Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine | Fluzone Quadrivalent Vaccine, 0.5-mL | 12.15 | 95% Confidence Interval 10.12 to 14.42 | percentage of participants | |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.25-mL | A/H1N1 | 214 | 95% Confidence Interval 185 to 247 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.5-mL | A/H1N1 | 310 | 95% Confidence Interval 271 to 354 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.25-mL | A/H3N2 | 221 | 95% Confidence Interval 191 to 256 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.5-mL | A/H3N2 | 332 | 95% Confidence Interval 290 to 380 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.25-mL | B Victoria | 261 | 95% Confidence Interval 227 to 299 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.5-mL | B Victoria | 348 | 95% Confidence Interval 304 to 398 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.25-mL | B Yamagata | 243 | 95% Confidence Interval 213 to 277 | Titers (1/dilutions [dil]) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Fluzone Quadrivalent Vaccine, 0.5-mL | B Yamagata | 349 | 95% Confidence Interval 307 to 397 | Titers (1/dilutions [dil]) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluzone Quadrivalent Vaccine, 0.25-mL | 955 | |
| Overall Study | STARTED | Fluzone Quadrivalent Vaccine, 0.5-mL | 995 | |
| Overall Study | Vaccinated (Safety Analysis Set) | Fluzone Quadrivalent Vaccine, 0.25-mL | 949 | |
| Overall Study | Vaccinated (Safety Analysis Set) | Fluzone Quadrivalent Vaccine, 0.5-mL | 992 | |
| Overall Study | COMPLETED | Fluzone Quadrivalent Vaccine, 0.25-mL | 890 | |
| Overall Study | COMPLETED | Fluzone Quadrivalent Vaccine, 0.5-mL | 917 | |
| Overall Study | NOT COMPLETED | Fluzone Quadrivalent Vaccine, 0.25-mL | 65 | |
| Overall Study | NOT COMPLETED | Fluzone Quadrivalent Vaccine, 0.5-mL | 78 |
Source ClinicalTrials.gov
Adverse events44
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 | Diarrhoea | Gastrointestinal disorders | Fluzone Quadrivalent Vaccine, 0.25-mL | 54 | 949 | |
| other | Diarrhoea | Gastrointestinal disorders | Fluzone Quadrivalent Vaccine, 0.5-mL | 58 | 992 | |
| other | Vomiting | Gastrointestinal disorders | Fluzone Quadrivalent Vaccine, 0.25-mL | 115 | 949 | |
| other | Vomiting | Gastrointestinal disorders | Fluzone Quadrivalent Vaccine, 0.5-mL | 109 | 992 | |
| other | Crying | General disorders | Fluzone Quadrivalent Vaccine, 0.25-mL | 302 | 949 | |
| other | Crying | General disorders | Fluzone Quadrivalent Vaccine, 0.5-mL | 321 | 992 | |
| other | Injection site erythema | General disorders | Fluzone Quadrivalent Vaccine, 0.25-mL | 210 | 949 | |
| other | Injection site erythema | General disorders | Fluzone Quadrivalent Vaccine, 0.5-mL | 228 | 992 | |
| other | Injection site pain | General disorders | Fluzone Quadrivalent Vaccine, 0.25-mL | 430 | 949 | |
| other | Injection site pain | General disorders | Fluzone Quadrivalent Vaccine, 0.5-mL | 473 | 992 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluzone Quadrivalent Vaccine, 0.25-mL | 0 | 949 |
| Total, all-cause mortality | Fluzone Quadrivalent Vaccine, 0.5-mL | 0 | 992 |
| Total, other adverse events | Fluzone Quadrivalent Vaccine, 0.25-mL | 698 | 949 |
| Total, other adverse events | Fluzone Quadrivalent Vaccine, 0.5-mL | 737 | 992 |
| Total, serious adverse events | Fluzone Quadrivalent Vaccine, 0.25-mL | 5 | 949 |
| Total, serious adverse events | Fluzone Quadrivalent Vaccine, 0.5-mL | 5 | 992 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30395011 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fluzone Quadrivalent Vaccine, 0.25-mL vs Fluzone Quadrivalent Vaccine, 0.5-mL: deaths from any cause | Trial comparisons |
| Fluzone Quadrivalent Vaccine, 0.25-mL vs Fluzone Quadrivalent Vaccine, 0.5-mL: 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.
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/NCT02915302
GET https://conductscience.org/api/trials/v1/NCT02915302/events?page=2