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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1243-5993 | Registry Identifier | ICTRP | |
| QHD00014 | Other Identifier | Sanofi Identifier | |
| 2019-004721-24 | EudraCT Number |
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The study was interrupted due to COVID-19 pandemic and terminated due to new changes to the recommendations for flu vaccines
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The primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type.
The secondary objectives of the study were:
The study was planned to start in the second half of 2020 with the Sentinel Safety Cohort. Following the Sentinel Safety Cohort, the main efficacy cohort was to be conducted during the 2021-2022 Northern Hemisphere influenza season (Season 1), the 2021-2022 Southern Hemisphere influenza season (Season 2), and the 2021-2022-2023 Northern Hemisphere influenza season (Season 3).
Participants received either 1 or 2 doses of the study vaccine depending on whether they were previously influenza vaccinated or previously influenza unvaccinated, respectively.
Study duration per participant was approximately 6 to 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIV-HD | Experimental | One injection of QIV-HD on Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. |
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| QIV-SD | Active Comparator | One injection of QIV-SD on Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent influenza vaccine, high-dose | Biological | Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes | Laboratory-confirmed influenza was a positive influenza result on either polymerase chain reaction (PCR) or viral culture. An influenza-like illness (ILI) was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Research Foundation Site Number : 8400008 | San Diego | California | 92123-1881 | United States | ||
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| Label | URL |
|---|---|
| QHD00014 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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The sentinel safety cohort of 100 participants were enrolled in the study. This study was prematurely terminated following a global shift in the influenza vaccine composition from quadrivalent to trivalent formulation for 2024-2025 season. Hence, main efficacy cohort was not conducted, and the safety analysis of the sentinel cohort was presented.
The sentinel safety cohort of the study was conducted at 10 centers from 15 September 2020 to 10 May 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose | Participants who were previously vaccinated against influenza received 1 dose of quadrivalent influenza vaccine (split virion, inactivated) high-dose (QIV-HD) intramuscular (IM) injection on Day 0. Participants who were not previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0 and 1 dose on Day 28. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2021 | Dec 8, 2025 |
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A sentinel safety cohort was selected for collection safety events where QIV-HD was administered open-label in 100 participants. These subjects did not provide blood samples and were not followed for influenza-like illness (ILI) surveillance.
A re-vaccination cohort was composed of a subset of approximately 120 participants from Season 1 (2021-2022 Northern Hemisphere) were re-enrolled and re-randomized in Season 3. The re-vaccination cohort was included, re-randomized to receive either QIV-HD or QIV-SD, provided blood samples in Season 1 and Season 3, and were not followed for ILI surveillance during their participation in Season 3.
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A total of 100 participants were in an uncontrolled, open-label sentinel cohort, while all other participants were in an randomized, modified double-blind design. The following measures ensured the integrity of the blinded data for the participants in the randomized, modified double-blind cohort:
| Quadrivalent influenza vaccine, standard dose | Biological | Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular |
|
| From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive in Participants Aged 6 Through 23 Months for Any Influenza A or B Type | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type According to Previous Vaccination Status | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine According to Previous Vaccination Status | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type and Associated With Acute Otitis Media (AOM) | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The AOM was based on clinical diagnosis. | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Acute Otitis Media | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The AOM was based on clinical diagnosis. | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type and Associated With Acute Lower Respiratory Infection (ALRI) | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The ALRI was based on a clinical and/or x-ray diagnosis. | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Acute Lower Respiratory Infection | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The ALRI was based on a clinical and/or x-ray diagnosis. | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Polymerase Chain Reaction-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine | The PCR-confirmed influenza was a positive influenza result on PCR. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Culture-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine | Culture-confirmed influenza was a positive influenza result on viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Polymerase Chain Reaction-Confirmed as Positive for Any Influenza A or B Types | The PCR-confirmed influenza was a positive influenza result on PCR. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Culture-Confirmed as Positive for Any Influenza A or B Types | Culture-confirmed influenza was a positive influenza result on viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Types and Associated With Hospitalization | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Hospitalization | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
| Geometric Mean Titer of Influenza Vaccine Antibodies | Antibody titers were measured by hemagglutination inhibition (HAI) assay. | Days 0 and 56 |
| Number of Participants With Seroconversion | Seroconversion for participants with a pre-vaccination titer <10 [1/dilution (dil)]: Post-injection titer >=40 (1/dil) on 28 days after the last vaccination or significant increase. Seroconversion for participants with a pre-vaccination titer >=10 (1/dil): >=4-fold increase from pre- to post-injection titer on 28 days after the last vaccination. Antibody titers were measured by HAI assay. | Days 0 and 56 |
| Number of Participants With Influenza Vaccine Antibody Titer >=10 (1/Dilution) | Antibody titers were measured by HAI assay. The influenza vaccine antibody titer level assessed was >=10 (1/dil). | Days 0 and 56 |
| Influenza Vaccine Antibody Titer Ratio | Antibody titer ratio was calculated as individual antibody titer 28 days after the last vaccination (Day 56) divided by individual antibody titer at Day 0. Antibody titers were measured by HAI assay. | Days 0 and 56 |
| Number of Participants With Influenza Vaccine Antibody Titer >=40 (1/Dilution) | Antibody titers were measured by HAI assay. The influenza vaccine antibody titer level assessed was >=40 (1/dil). | Days 0 and 56 |
| Influenza Seroneutralization (SN) Antibody Titer | The antibody titers were measured by the SN method. | Days 0 and 56 |
| Influenza Seroneutralization Antibody Titer Ratio | Antibody titer ratio was calculated as fold increase in serum SN post-vaccination relative to Day 0. Antibody titers were measured by the SN method. | Day 56 |
| Number of Participants With Influenza Seroneutralization Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution) | Antibody titers were measured by the SN method. The SN antibody titer levels assessed were >=20 (1/dil), >=40 (1/dil) and >=80 (1/dil). | Day 56 |
| Number of Participants With Influenza Seroneutralization Antibody Titer >=2 and >=4 Fold-Rise | Increase of titer levels >=2 and >=4 were assessed. Antibody titers were measured by the SN method. | Day 56 |
| Detectable Influenza Seroneutralization Antibody Titer | Detectable antibody titers were >=10 (1/dil). Antibody titers were measured by the SN method. | Days 0 and 56 |
| Anti-Neuraminidase (Anti-NA) Antibody Titer | Antibody titers were measured by enzyme-linked lectin assay. | Days 0 and 56 |
| Anti-Neuraminidase Antibody Titer Ratio | Antibody titer ratio was calculated as fold increase in anti-NA antibodies post-vaccination relative to Day 0. Antibody titers were measured by enzyme-linked lectin assay. | Day 56 |
| Number of Participants With Anti-Neuraminidase Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution) | Antibody titers were measured by enzyme-linked lectin assay. Anti-NA antibody titer levels assessed were >=20 (1/dil), >=40 (1/dil) and >=80 (1/dil). | Day 56 |
| Number of Participants With Anti-Neuraminidase Antibody Titer >=2 and >=4 Fold-Rise | Increase of titer levels >=2 and >=4 were assessed. Antibody titers were measured by enzyme-linked lectin assay. | Day 56 |
| Detectable Anti-Neuraminidase Antibody Titer | Detectable antibody titers were >=10 (1/dil). Antibody titers were measured by enzyme-linked lectin assay. | Days 0 and 56 |
| Number of Participants With Unsolicited Systemic Adverse Events (AEs) After Each Vaccine Dose Administration | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. | Within 30 minutes after each vaccine administration (vaccines administered at Days 0 and 28) |
| Number of Participants With Solicited Injection Site Reactions After Each Vaccine Dose Administration | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form, and were considered to be related to the study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. | Within 7 days after each vaccine administration (vaccines administered at Days 0 and 28) |
| Number of Participants With Solicited Systemic Reactions After Each Vaccine Dose Administration | A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form, and were considered to be related to the study vaccine administered. Systemic AR were all ARs that were not injection site reactions. | Within 7 days after each vaccine administration (vaccines administered at Days 0 and 28) |
| Number of Participants With Unsolicited Adverse Events After Each Vaccine Dose Administration | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. | Within 28 days after each vaccine administration (vaccines administered at Days 0 and 28) |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | An SAE was defined as any AE 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 (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. | From first dose of study vaccine administration (Day 1) up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 210 days |
| Acevedo Clinical Research Associates Site Number : 8400007 |
| Miami |
| Florida |
| 33142 |
| United States |
| Emory Childrens Center- Site Number : 8400001 | Atlanta | Georgia | 30322 | United States |
| Heartland El Dorado- Site Number : 8400032 | El Dorado | Kansas | 67042 | United States |
| Kentucky Pediatrics / Adult Research- Site Number : 8400005 | Bardstown | Kentucky | 40004 | United States |
| Velocity Clinical Research- New Orleans Site Number : 8400009 | New Orleans | Louisiana | 70119 | United States |
| Ohio Pediatric Research- Site Number : 8400027 | Dayton | Ohio | 45414 | United States |
| Rainbow Pediatrics- Site Number : 8400033 | Barnwell | South Carolina | 29812 | United States |
| Cenexel JBR- Site Number : 8400006 | Salt Lake City | Utah | 84107 | United States |
| Foothill Family Clinic South- Site Number : 8400045 | Salt Lake City | Utah | 84121 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Expanded safety analysis set included participants who received at least 1 dose of the study vaccine in the sentinel safety cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose | Participants who were previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0. Participants who were not previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0 and 1 dose on Day 28. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes | Laboratory-confirmed influenza was a positive influenza result on either polymerase chain reaction (PCR) or viral culture. An influenza-like illness (ILI) was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive in Participants Aged 6 Through 23 Months for Any Influenza A or B Type | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type According to Previous Vaccination Status | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine According to Previous Vaccination Status | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type and Associated With Acute Otitis Media (AOM) | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The AOM was based on clinical diagnosis. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Acute Otitis Media | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The AOM was based on clinical diagnosis. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type and Associated With Acute Lower Respiratory Infection (ALRI) | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The ALRI was based on a clinical and/or x-ray diagnosis. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Acute Lower Respiratory Infection | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). The ALRI was based on a clinical and/or x-ray diagnosis. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Polymerase Chain Reaction-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine | The PCR-confirmed influenza was a positive influenza result on PCR. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Culture-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine | Culture-confirmed influenza was a positive influenza result on viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Polymerase Chain Reaction-Confirmed as Positive for Any Influenza A or B Types | The PCR-confirmed influenza was a positive influenza result on PCR. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Culture-Confirmed as Positive for Any Influenza A or B Types | Culture-confirmed influenza was a positive influenza result on viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Types and Associated With Hospitalization | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Hospitalization | Laboratory-confirmed influenza was a positive influenza result on either PCR or viral culture. An ILI was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days |
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| Secondary | Geometric Mean Titer of Influenza Vaccine Antibodies | Antibody titers were measured by hemagglutination inhibition (HAI) assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Number of Participants With Seroconversion | Seroconversion for participants with a pre-vaccination titer <10 [1/dilution (dil)]: Post-injection titer >=40 (1/dil) on 28 days after the last vaccination or significant increase. Seroconversion for participants with a pre-vaccination titer >=10 (1/dil): >=4-fold increase from pre- to post-injection titer on 28 days after the last vaccination. Antibody titers were measured by HAI assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Number of Participants With Influenza Vaccine Antibody Titer >=10 (1/Dilution) | Antibody titers were measured by HAI assay. The influenza vaccine antibody titer level assessed was >=10 (1/dil). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Influenza Vaccine Antibody Titer Ratio | Antibody titer ratio was calculated as individual antibody titer 28 days after the last vaccination (Day 56) divided by individual antibody titer at Day 0. Antibody titers were measured by HAI assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Number of Participants With Influenza Vaccine Antibody Titer >=40 (1/Dilution) | Antibody titers were measured by HAI assay. The influenza vaccine antibody titer level assessed was >=40 (1/dil). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Influenza Seroneutralization (SN) Antibody Titer | The antibody titers were measured by the SN method. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Influenza Seroneutralization Antibody Titer Ratio | Antibody titer ratio was calculated as fold increase in serum SN post-vaccination relative to Day 0. Antibody titers were measured by the SN method. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Day 56 |
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| Secondary | Number of Participants With Influenza Seroneutralization Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution) | Antibody titers were measured by the SN method. The SN antibody titer levels assessed were >=20 (1/dil), >=40 (1/dil) and >=80 (1/dil). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Day 56 |
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| Secondary | Number of Participants With Influenza Seroneutralization Antibody Titer >=2 and >=4 Fold-Rise | Increase of titer levels >=2 and >=4 were assessed. Antibody titers were measured by the SN method. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Day 56 |
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| Secondary | Detectable Influenza Seroneutralization Antibody Titer | Detectable antibody titers were >=10 (1/dil). Antibody titers were measured by the SN method. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Anti-Neuraminidase (Anti-NA) Antibody Titer | Antibody titers were measured by enzyme-linked lectin assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Anti-Neuraminidase Antibody Titer Ratio | Antibody titer ratio was calculated as fold increase in anti-NA antibodies post-vaccination relative to Day 0. Antibody titers were measured by enzyme-linked lectin assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Day 56 |
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| Secondary | Number of Participants With Anti-Neuraminidase Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution) | Antibody titers were measured by enzyme-linked lectin assay. Anti-NA antibody titer levels assessed were >=20 (1/dil), >=40 (1/dil) and >=80 (1/dil). | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Day 56 |
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| Secondary | Number of Participants With Anti-Neuraminidase Antibody Titer >=2 and >=4 Fold-Rise | Increase of titer levels >=2 and >=4 were assessed. Antibody titers were measured by enzyme-linked lectin assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Day 56 |
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| Secondary | Detectable Anti-Neuraminidase Antibody Titer | Detectable antibody titers were >=10 (1/dil). Antibody titers were measured by enzyme-linked lectin assay. | The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed. | Posted | Days 0 and 56 |
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| Secondary | Number of Participants With Unsolicited Systemic Adverse Events (AEs) After Each Vaccine Dose Administration | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. | Expanded safety analysis set included participants who received at least 1 dose of the study vaccine in the sentinel safety cohort. | Posted | Count of Participants | Participants | Within 30 minutes after each vaccine administration (vaccines administered at Days 0 and 28) |
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| Secondary | Number of Participants With Solicited Injection Site Reactions After Each Vaccine Dose Administration | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form, and were considered to be related to the study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. | Expanded safety analysis set included participants who received at least 1 dose of the study vaccine in the sentinel safety cohort. | Posted | Count of Participants | Participants | Within 7 days after each vaccine administration (vaccines administered at Days 0 and 28) |
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| Secondary | Number of Participants With Solicited Systemic Reactions After Each Vaccine Dose Administration | A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form, and were considered to be related to the study vaccine administered. Systemic AR were all ARs that were not injection site reactions. | Expanded safety analysis set included participants who received at least 1 dose of the study vaccine in the sentinel safety cohort. | Posted | Count of Participants | Participants | Within 7 days after each vaccine administration (vaccines administered at Days 0 and 28) |
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| Secondary | Number of Participants With Unsolicited Adverse Events After Each Vaccine Dose Administration | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. | Expanded safety analysis set included participants who received at least 1 dose of the study vaccine in the sentinel safety cohort. | Posted | Count of Participants | Participants | Within 28 days after each vaccine administration (vaccines administered at Days 0 and 28) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | An SAE was defined as any AE 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 (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. | Expanded safety analysis set included participants who received at least 1 dose of the study vaccine in the sentinel safety cohort. | Posted | Count of Participants | Participants | From first dose of study vaccine administration (Day 1) up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 210 days |
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From first dose of study vaccine administration (Day 1) up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 210 days.
Analysis was performed on the expanded safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose | Participants who were previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0. Participants who were not previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0 and 1 dose on Day 28. | 0 | 100 | 1 | 100 | 65 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis Media Acute | Infections and infestations | MedDra 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
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| Crying | General disorders | MedDra 27.1 | Systematic Assessment |
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| Injection Site Bruising | General disorders | MedDra 27.1 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDra 27.1 | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDra 27.1 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDra 27.1 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDra 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
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The main efficacy cohort was not conducted due to shift in the global influenza vaccine guidelines. Hence, no analysis was performed.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2020 | Dec 8, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| White |
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| Mixed Origin |
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| Not Reported |
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