Trial · NCT05513053
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
NCT05513053, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2024-05-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. Trials, record NCT05513053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05513053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
- NCT number
- NCT05513053
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,308 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Influenza Immunization
- Interventions
- Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
- First posted
- 2022-08-23
- Last updated
- 2025-09-09
- Other registries' IDs
- eudract:2022-000577-11
- Results first posted
- 2024-05-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Day 29 | GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. |
| Primary | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | Day 29 | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer. |
| Secondary | GMTs Against Influenza Vaccine Antibodies at Day 1 | Pre-vaccination on Day 1 | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. |
| Secondary | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | On Days 1 and 29 | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 and \>=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. |
| Secondary | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | On Days 1 and 29 | GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. |
| Secondary | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination on Day 1 | An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs. |
| Secondary | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | From Day 1 up to 7 days post-vaccination (up to Day 8) | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology. |
| Secondary | Number of Participants With Unsolicited AEs | From Day 1 up to 28 days post-vaccination (up to Day 29) | An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. |
| Secondary | Number of Participants With Medically Attended Adverse Events (MAAEs) | From Day 1 up to 28 days post-vaccination (up to Day 29) | An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | From Day 1 up to 6 months post-vaccination, 181 days | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Day 29 | Analysis was performed on the Per-protocol analysis set (PPAS)-subset of full analysis set (FAS) which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. | titer | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | Day 29 | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 29 are reported. | percentage of participants | NUMBER |
| SECONDARY | GMTs Against Influenza Vaccine Antibodies at Day 1 | Pre-vaccination on Day 1 | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 1 are reported. | titer | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | On Days 1 and 29 | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category on Days 1 and 29 are reported. | percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | On Days 1 and 29 | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category on Days 1 and Day 29 are reported. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination on Day 1 | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | From Day 1 up to 7 days post-vaccination (up to Day 8) | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. Number of participants analyzed signifies those participants with data collected for this outcome measure and number analyzed signifies those participants with data collected for specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Unsolicited AEs | From Day 1 up to 28 days post-vaccination (up to Day 29) | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Attended Adverse Events (MAAEs) | From Day 1 up to 28 days post-vaccination (up to Day 29) | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | From Day 1 up to 6 months post-vaccination, 181 days | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 1: Participants Aged 9 to 17 Years | A/H1N1 | 1946 | 95% Confidence Interval 1795 to 2109 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 2: Participants Aged 18 to 49 Years | A/H1N1 | 982 | 95% Confidence Interval 881 to 1094 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 1: Participants Aged 9 to 17 Years | A/H3N2 | 1975 | 95% Confidence Interval 1771 to 2202 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 2: Participants Aged 18 to 49 Years | A/H3N2 | 604 | 95% Confidence Interval 531 to 687 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 1: Participants Aged 9 to 17 Years | B/Victoria | 405 | 95% Confidence Interval 362 to 452 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 2: Participants Aged 18 to 49 Years | B/Victoria | 258 | 95% Confidence Interval 233 to 285 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 1: Participants Aged 9 to 17 Years | B/Yamagata | 1941 | 95% Confidence Interval 1779 to 2118 | titer |
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | Cohort 2: Participants Aged 18 to 49 Years | B/Yamagata | 1593 | 95% Confidence Interval 1477 to 1717 | titer |
| Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | Cohort 1: Participants Aged 9 to 17 Years | A/H1N1 | 78.3 | 95% Confidence Interval 74.8 to 81.5 | percentage of participants |
| Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | Cohort 2: Participants Aged 18 to 49 Years | A/H1N1 | 76.4 | 95% Confidence Interval 72.8 to 79.7 | percentage of participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Participants Aged 9 to 17 Years | 648 | |
| Overall Study | STARTED | Cohort 2: Participants Aged 18 to 49 Years | 660 | |
| Overall Study | COMPLETED | Cohort 1: Participants Aged 9 to 17 Years | 629 | |
| Overall Study | COMPLETED | Cohort 2: Participants Aged 18 to 49 Years | 635 | |
| Overall Study | NOT COMPLETED | Cohort 1: Participants Aged 9 to 17 Years | 19 | |
| Overall Study | NOT COMPLETED | Cohort 2: Participants Aged 18 to 49 Years | 25 |
Source ClinicalTrials.gov
Adverse events30
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 | Headache | Nervous system disorders | Cohort 1: Participants Aged 9 to 17 Years | 114 | 641 | 121 |
| other | Headache | Nervous system disorders | Cohort 2: Participants Aged 18 to 49 Years | 152 | 658 | 153 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Cohort 1: Participants Aged 9 to 17 Years | 119 | 641 | 119 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Cohort 2: Participants Aged 18 to 49 Years | 129 | 658 | 129 |
| other | Chills | General disorders | Cohort 1: Participants Aged 9 to 17 Years | 45 | 641 | 45 |
| other | Chills | General disorders | Cohort 2: Participants Aged 18 to 49 Years | 40 | 658 | 40 |
| other | Injection Site Pain | General disorders | Cohort 1: Participants Aged 9 to 17 Years | 212 | 641 | 212 |
| other | Injection Site Pain | General disorders | Cohort 2: Participants Aged 18 to 49 Years | 255 | 658 | 256 |
| other | Malaise | General disorders | Cohort 1: Participants Aged 9 to 17 Years | 100 | 641 | 100 |
| other | Malaise | General disorders | Cohort 2: Participants Aged 18 to 49 Years | 106 | 658 | 106 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Participants Aged 9 to 17 Years | 0 | 641 |
| Total, all-cause mortality | Cohort 2: Participants Aged 18 to 49 Years | 0 | 658 |
| Total, other adverse events | Cohort 1: Participants Aged 9 to 17 Years | 263 | 641 |
| Total, other adverse events | Cohort 2: Participants Aged 18 to 49 Years | 336 | 658 |
| Total, serious adverse events | Cohort 1: Participants Aged 9 to 17 Years | 3 | 641 |
| Total, serious adverse events | Cohort 2: Participants Aged 18 to 49 Years | 7 | 658 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40412421 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Trial comparisons |
| Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With Unsolicited AEs | Trial comparisons |
| Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With Medically Attended Adverse Events (MAAEs) | Trial comparisons |
| Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: deaths from any cause | Trial comparisons |
| Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: 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/NCT05513053
GET https://conductscience.org/api/trials/v1/NCT05513053/results?page=2