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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1189-3713 | Other Identifier | WHO | |
| 2018-005026-39 | EudraCT Number |
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The objectives of this study were:
Study duration per participant was approximately 180 days for participants who received one dose of vaccine and 208 days for participants who received two doses of vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 months to 17 years) | Experimental | Participants from United States (US) (aged 6 months to 17 years) received single injection of 30 microgram (μg) QIV-HD, intramuscularly (IM) at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
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| Group 2: QIV-HD 45 μg (US: 6 months to 17 years) | Experimental | Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
| Group 3: QIV-HD, 60 μg (US: 6 months to 17 years) | Experimental | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
| Group 4: Pooled QIV-SD, 15 μg (US: 6 months to 17 years) | Active Comparator | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. | Within 30 minutes after any vaccination |
| Number of Participants With Unsolicited Adverse Events After Any Vaccination | An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Adverse reactions (ARs) were AEs related to vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions. | Within 28 days after any vaccination |
| Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as SAEs which included new onset of Guillain-Barré syndrome, encephalitis/myelitis (including transverse myelitis), Bell's palsy, convulsions, optic neuritis, and brachial neuritis. |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant'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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400004 | San Diego | California | 92123-1881 | United States | ||
| Investigational Site Number 8400001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33610374 | Result | Chang LJ, Anderson EJ, Jeanfreau R, He Y, Hicks B, Shrestha A, Pandey A, Landolfi V, DeBruijn I; QHD04 Study Group. Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through <18 years of age: A randomized controlled phase II dose-finding trial. Vaccine. 2021 Mar 12;39(11):1572-1582. doi: 10.1016/j.vaccine.2021.02.014. Epub 2021 Feb 18. |
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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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A total of 665 participants were enrolled in the study.
The study was conducted at 16 centers in United States (US) and Canada from 09 October 2018 to 16 October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 30 microgram (μg) high-dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at 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 | Feb 25, 2019 | May 14, 2020 |
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The study was divided into 13 groups and enrolled participants in 4 stages. The study used a stepwise age de-escalation and dose ascension design for children 6 months to less than (<) 5 years of age.
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Modified double-blind: the participant's parent / legally acceptable representative, the Investigator, and other study personnel remained unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.
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| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 months) | Experimental | Participants from Canada (aged 6 to less than [<] 24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
| Group 6: Adjuvanted TIV (Canada: 6 to <24 months) | Active Comparator | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
|
| Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated) | Biological | Pharmaceutical form: Solution for injection Route of administration: IM |
|
| FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated) | Biological | Pharmaceutical form: Solution for injection Route of administration: IM |
|
| From Day 0 up to 6 months (i.e. 180 days) post last vaccination |
| Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Anti-influenza antibodies were measured by hemagglutination inhibition (HAI) assay for strains A/H1N1, A/H3N2, B/Victoria and B/Yamagata lineage. Seroconversion: defined as either HAI titer <10(1/dilution) at Day 0 and post-vaccination titer greater than or equal to (>=)40(1/dilution) at Day 28, or HAI titer >=10(1/dilution) at Day 0 and >=4-fold increase in HAI titer (1/dilution) at Day 28. Data for this Outcome Measure (OM) was planned to be collected and reported for dose level (QIV-HD 30μg and 45μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to complex study design and analysis of doses and age groups, QIV-SD group participants, who matched to participants in QIV-HD 30μg and 45μg dose formulations groups (who were 9 through 17 years old and shared matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable. | Day 28 post any vaccination |
| Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Data for this OM was planned to be collected and reported for dose level (QIV-HD 30 μg and QIV-HD 45 μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to the complex study design and analysis of the dose formulation and age groups in the study, QIV-SD group participants, who matched to participants in the QIV-HD 30 μg and QIV-HD 45 μg dose formulations groups (who were 9 through 17 years old and shared a matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable. | Day 28 post any vaccination |
| Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-vaccination and pre-vaccination. | Day 0 (pre-vaccination), Day 28 (post any vaccination) |
| Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMT was measured for each influenza strain using HAI assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. | Day 28 post any vaccination |
| Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMT was measured for each influenza strain using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. | Day 28 post any vaccination |
| Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMTRs of anti-influenza antibodies were measured using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage and B/Yamagata lineage. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Day 0 (pre-vaccination), Day 28 (post any vaccination) |
| Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | Neutralizing Antibody titer was measured for each influenza strain with SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage at pre-defined thresholds of >=20, >=40 and >=80 (1/dilution). | Day 28 post any vaccination |
| Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | Neutralizing Antibody titer was measured for each influenza strain with SN method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / pre-vaccination computed value. | Day 28 post any vaccination |
| Number of Participants With Solicited Injection Site Reactions | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included tenderness/pain, erythema, swelling, induration and bruising. | Within 7 days after any vaccination |
| Number of Participants With Solicited Systemic Reactions After Any Vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. Fever was planned to be evaluated for the whole population where as, the other events (vomiting, crying abnormal, drowsiness, appetite lost, and irritability) were planned to be evaluated only in the participants aged 6 months to <36 months. | Within 7 days after any vaccination |
| Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included: headache, malaise, myalgia and shivering. | Within 7 days after any vaccination |
| Miami |
| Florida |
| 33186 |
| United States |
| Investigational Site Number 8400002 | Atlanta | Georgia | 30322 | United States |
| Investigational Site Number 8400013 | El Dorado | Kansas | 67042 | United States |
| Investigational Site Number 8400015 | Newton | Kansas | 67114 | United States |
| Investigational Site Number 8400009 | Wichita | Kansas | 67207 | United States |
| Investigational Site Number 8400007 | Metairie | Louisiana | 70006 | United States |
| Investigational Site Number 8400010 | Las Vegas | Nevada | 89104 | United States |
| Investigational Site Number 8400011 | Warwick | Rhode Island | 02886 | United States |
| Investigational Site Number 8400003 | Salt Lake City | Utah | 84107 | United States |
| Investigational Site Number 8400012 | Salt Lake City | Utah | 84109 | United States |
| Investigational Site Number 8400005 | Salt Lake City | Utah | 84121 | United States |
| Investigational Site Number 8400014 | West Jordan | Utah | 84088-8865 | United States |
| Investigational Site Number 1241003 | Montreal | H3T 1C5 | Canada |
| Investigational Site Number 1241002 | Pierrefonds | H9H 4Y6 | Canada |
| Investigational Site Number 1241001 | Québec | G1E 7G9 | Canada |
| FG001 |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) |
Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| FG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| FG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| FG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to less than [<] 24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| FG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted trivalent influenza vaccine (TIV), IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Safety Analysis Set Population (SafAS) | SafAS: Included participants who had received at least one dose of the study vaccines. |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on the randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| BG001 | Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| BG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| BG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| BG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| BG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| BG006 | Total | Total of all reporting groups |
| 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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| Age, Customized | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. | Analysis was performed on SafAS population which included participants who had received at least one dose of the study vaccines. | Posted | Count of Participants | Participants | Within 30 minutes after any vaccination |
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| Primary | Number of Participants With Unsolicited Adverse Events After Any Vaccination | An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Adverse reactions (ARs) were AEs related to vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions. | Analysis was performed on the SafAS population. | Posted | Count of Participants | Participants | Within 28 days after any vaccination |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as SAEs which included new onset of Guillain-Barré syndrome, encephalitis/myelitis (including transverse myelitis), Bell's palsy, convulsions, optic neuritis, and brachial neuritis. | Analysis was performed on the SafAS population. | Posted | Count of Participants | Participants | From Day 0 up to 6 months (i.e. 180 days) post last vaccination |
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| Primary | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Anti-influenza antibodies were measured by hemagglutination inhibition (HAI) assay for strains A/H1N1, A/H3N2, B/Victoria and B/Yamagata lineage. Seroconversion: defined as either HAI titer <10(1/dilution) at Day 0 and post-vaccination titer greater than or equal to (>=)40(1/dilution) at Day 28, or HAI titer >=10(1/dilution) at Day 0 and >=4-fold increase in HAI titer (1/dilution) at Day 28. Data for this Outcome Measure (OM) was planned to be collected and reported for dose level (QIV-HD 30μg and 45μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to complex study design and analysis of doses and age groups, QIV-SD group participants, who matched to participants in QIV-HD 30μg and 45μg dose formulations groups (who were 9 through 17 years old and shared matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable. | Analysis was performed on immunogenicity analysis set (IAS) population which included randomized participants who received 1 dose or 2 doses of study vaccine and had a post-vaccination blood sample. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Count of Participants | Participants | Day 28 post any vaccination |
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| Primary | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Data for this OM was planned to be collected and reported for dose level (QIV-HD 30 μg and QIV-HD 45 μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to the complex study design and analysis of the dose formulation and age groups in the study, QIV-SD group participants, who matched to participants in the QIV-HD 30 μg and QIV-HD 45 μg dose formulations groups (who were 9 through 17 years old and shared a matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable. | Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | Day 28 post any vaccination |
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| Primary | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-vaccination and pre-vaccination. | Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-vaccination), Day 28 (post any vaccination) |
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| Primary | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMT was measured for each influenza strain using HAI assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. | Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Count of Participants | Participants | Day 28 post any vaccination |
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| Primary | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMT was measured for each influenza strain using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. | Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | Day 28 post any vaccination |
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| Primary | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | GMTRs of anti-influenza antibodies were measured using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage and B/Yamagata lineage. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-vaccination), Day 28 (post any vaccination) |
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| Primary | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | Neutralizing Antibody titer was measured for each influenza strain with SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage at pre-defined thresholds of >=20, >=40 and >=80 (1/dilution). | Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Count of Participants | Participants | Day 28 post any vaccination |
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| Primary | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | Neutralizing Antibody titer was measured for each influenza strain with SN method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / pre-vaccination computed value. | Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Count of Participants | Participants | Day 28 post any vaccination |
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| Primary | Number of Participants With Solicited Injection Site Reactions | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included tenderness/pain, erythema, swelling, induration and bruising. | Analysis was performed on the SafAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Within 7 days after any vaccination |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Systemic Reactions After Any Vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. Fever was planned to be evaluated for the whole population where as, the other events (vomiting, crying abnormal, drowsiness, appetite lost, and irritability) were planned to be evaluated only in the participants aged 6 months to <36 months. | Analysis was performed on the SafAS population. Here, 'number analyzed' = number of participants with available data for each specified category. | Posted | Count of Participants | Participants | Within 7 days after any vaccination |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included: headache, malaise, myalgia and shivering. | Analysis was performed on the SafAS population. Here, "overall number of participants analyzed"= participants evaluable for this outcome measure. Data not collected and reported for Groups 5 and 6 because none of the participants in both groups lies in the age group of >36 months. | Posted | Count of Participants | Participants | Within 7 days after any vaccination |
|
AEs were collected from Day 0 (post-vaccination) up to 28 days after last vaccination. Solicited Reaction (SR) data were collected up to Day 7 after any vaccination. SAE data were collected throughout the study (up to 180 days after last vaccination).
An SR was an AE that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS population.
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 | Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 0 | 122 | 0 | 122 | 101 | 122 |
| EG001 | Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 0 | 121 | 0 | 121 | 100 | 121 |
| EG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 0 | 158 | 2 | 158 | 118 | 158 |
| EG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 0 | 234 | 0 | 234 | 165 | 234 |
| EG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 0 | 13 | 0 | 13 | 13 | 13 |
| EG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 0 | 13 | 1 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Infection | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA-22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Oral Mucosal Eruption | Gastrointestinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Injection Site Warmth | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA-22.0 | Systematic Assessment |
| |
| Tongue Injury | Injury, poisoning and procedural complications | MedDRA-22.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Sleep Terror | Psychiatric disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA-22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA-22.0 | Systematic Assessment |
|
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 participant 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 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 4, 2019 | May 14, 2020 | 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 |
| D000954 | Antigens, Surface |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| 6 - < 36 months |
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| 36 months - < 5 years |
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| 5 - 8 years |
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| 9 - 17 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
| OG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
| OG001 | Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4a: QIV-SD, 15 μg, (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 30 μg. |
| OG004 | Group 4b: QIV-SD, 15 μg, (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 45 μg. |
| OG005 | Group 4c: QIV-SD, 15 μg, (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 60 μg. |
| OG006 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG007 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4a: QIV-SD, 15 μg, (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 30 μg. |
| OG004 | Group 4b: QIV-SD, 15 μg, (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 45 μg. |
| OG005 | Group 4c: QIV-SD, 15 μg, (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received 15 μg QIV-SD, IM and were restricted for comparison to relevant experimental study group QIV-HD 60 μg. |
| OG006 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG007 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
| OG002 | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG004 | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG005 | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Participants from Canada (aged 6 to <24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
|
|
| OG002 |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) |
Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| OG003 | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
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