InfluenzaPhase 3QHD00014NCT04544267
Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
A Phase 3 study testing Quadrivalent influenza vaccine, high-dose and Quadrivalent influenza vaccine, standard dose in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent influenza vaccine, high-dose and Quadrivalent influenza vaccine, standard dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Sep 2020to 2 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6 to 35 months on the day of the first study visit
- Informed consent form was signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations.
- Participant and parent / guardian who were able to attend all scheduled visits and to comply with all study procedures.
- Covered by health insurance if required by local regulations
- For Season 3 Re-vaccination Cohort: eligible participants must have been enrolled in the Season 1 (2021-2022 Northern Hemisphere season) immunogenicity subset and must have completed all study procedures (ie, blood draws and vaccinations) in Season 1.
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- For all participants: Receipt of any vaccine in the 30 days preceding the first study vaccination. For participants in immunogenicity subset: Planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
- Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another influenza vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency (eg, HIV); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. Exception: participants with an egg allergy are allowed to enroll in the study.
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- Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination
- Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion.
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). A prospective participant would not be included in the study until the condition was resolved or the febrile event was subsided.
- Identified as natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
- Personal or family history of Guillain-Barre Syndrome.
- Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
- Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
- For Season 3 (2022-2023 Northern Hemisphere) main cohort: participants who were enrolled in a previous study season are excluded from Season 3, with the exception of the Re-vaccination Cohort.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory Childrens Center- Site Number : 8400001
Atlanta, Georgia, 30322
Kentucky Pediatrics / Adult Research- Site Number : 8400005
Bardstown, Kentucky, 40004
Rainbow Pediatrics- Site Number : 8400033
Barnwell, South Carolina, 29812
Ohio Pediatric Research- Site Number : 8400027
Dayton, Ohio, 45414
Heartland El Dorado- Site Number : 8400032
El Dorado, Kansas, 67042
Acevedo Clinical Research Associates Site Number : 8400007
Miami, Florida, 33142
Velocity Clinical Research- New Orleans Site Number : 8400009
New Orleans, Louisiana, 70119
Cenexel JBR- Site Number : 8400006
Salt Lake City, Utah, 84107
Foothill Family Clinic South- Site Number : 8400045
Salt Lake City, Utah, 84121
California Research Foundation Site Number : 8400008
San Diego, California, 92123-1881
About this study
Official title: Efficacy, Immunogenicity, and Safety of High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
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:
- To compare QIV-HD to 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 using a more stringent threshold
- in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine.
- in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types.
- To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age
- To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response
- To describe the immune response to revaccination in Season 3 (Northern Hemisphere)
- To describe the safety profile of each vaccine
Read the detailed description
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.
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza vaccine, high-dose, Quadrivalent influenza vaccine, standard dose
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent influenza vaccine, high-doseBiological
Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
Quadrivalent influenza vaccine, standard doseBiological
Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Quadrivalent influenza vaccine, high-dose |
| 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. Receives: Biological: Quadrivalent influenza vaccine, standard dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Secondary outcomes (34)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Days 0 and 56
Influenza Seroneutralization (SN) Antibody Titer
The antibody titers were measured by the SN method.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 56
Detectable Influenza Seroneutralization Antibody Titer
Detectable antibody titers were >=10 (1/dil). Antibody titers were measured by the SN method.
Measured: Days 0 and 56
Anti-Neuraminidase (Anti-NA) Antibody Titer
Antibody titers were measured by enzyme-linked lectin assay.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 56
Detectable Anti-Neuraminidase Antibody Titer
Detectable antibody titers were >=10 (1/dil). Antibody titers were measured by enzyme-linked lectin assay.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start15 Sep 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Why it stopped: The study was interrupted due to COVID-19 pandemic and terminated due to new changes to the recommendations for flu vaccines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544267
- Sponsor's protocol ID
- QHD00014
- Other IDs
- U1111-1243-5993, QHD00014, 2019-004721-24, 2019
- Acronym
- QHD00014
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2020
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Immunogenicity, and Safety of High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
- ClinicalTrials.gov ID
- NCT04544267
- Acronym / sponsor ID
- QHD00014 / QHD00014
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was interrupted due to COVID-19 pandemic and terminated due to new changes to the recommendations for flu vaccines
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare QIV-HD to 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 using a more stringent threshold
- in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine.
- in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types.
- To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age
- To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response
- To describe the immune response to revaccination in Season 3 (Northern Hemisphere)
- To describe the safety profile of each vaccine
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| QIV-HD | Experimental | Biological: Quadrivalent influenza vaccine, high-doseOne 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. |
| QIV-SD | Active comparator | Biological: Quadrivalent influenza vaccine, standard doseOne 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. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 6 to 35 months on the day of the first study visit
- Informed consent form was signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations.
- Participant and parent / guardian who were able to attend all scheduled visits and to comply with all study procedures.
- Covered by health insurance if required by local regulations
- For Season 3 Re-vaccination Cohort: eligible participants must have been enrolled in the Season 1 (2021-2022 Northern Hemisphere season) immunogenicity subset and must have completed all study procedures (ie, blood draws and vaccinations) in Season 1.
Key exclusion criteria (15 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- For all participants: Receipt of any vaccine in the 30 days preceding the first study vaccination. For participants in immunogenicity subset: Planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
- Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another influenza vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency (eg, HIV); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent influenza vaccine, high-dosePharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular | Biological | QIV-HD |
| Quadrivalent influenza vaccine, standard dosePharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular | Biological | QIV-SD |
Primary outcome
Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes
Time frame: 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
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).
34 secondary outcomes
Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 0 and 56
Number of Participants With Seroconversion
Time frame: Days 0 and 56
Number of Participants With Influenza Vaccine Antibody Titer >=10 (1/Dilution)
Time frame: Days 0 and 56
Influenza Vaccine Antibody Titer Ratio
Time frame: Days 0 and 56
Number of Participants With Influenza Vaccine Antibody Titer >=40 (1/Dilution)
Time frame: Days 0 and 56
Influenza Seroneutralization (SN) Antibody Titer
Time frame: Days 0 and 56
Influenza Seroneutralization Antibody Titer Ratio
Time frame: Day 56
Number of Participants With Influenza Seroneutralization Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution)
Time frame: Day 56
Number of Participants With Influenza Seroneutralization Antibody Titer >=2 and >=4 Fold-Rise
Time frame: Day 56
Detectable Influenza Seroneutralization Antibody Titer
Time frame: Days 0 and 56
Anti-Neuraminidase (Anti-NA) Antibody Titer
Time frame: Days 0 and 56
Anti-Neuraminidase Antibody Titer Ratio
Time frame: Day 56
Number of Participants With Anti-Neuraminidase Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution)
Time frame: Day 56
Number of Participants With Anti-Neuraminidase Antibody Titer >=2 and >=4 Fold-Rise
Time frame: Day 56
Detectable Anti-Neuraminidase Antibody Titer
Time frame: Days 0 and 56
Number of Participants With Unsolicited Systemic Adverse Events (AEs) After Each Vaccine Dose Administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- QHD00014 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent influenza vaccine, high-dose and Quadrivalent influenza vaccine, standard dose in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.