Influenza
Conditions
Keywords
Influenza, Quadrivalent Inactivated Influenza Vaccine (QIV)
Brief summary
The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India: Primary objective: * To describe in each age group the immune response induced by a single injection (participants aged \>9 years) or 2 injections (participants aged 6 months to 8 years) of QIV. Secondary objective: * To describe in each age group the safety profile of QIV.
Detailed description
All participants were vaccinated with the QIV (split-virion, inactivated) Northern Hemisphere (NH) or Southern Hemisphere (SH) formulations by the intramuscular (IM) route. Immunogenicity of the vaccine was assessed at baseline (Day 0) and 28 days after the last injection. Safety data were collected up to 28 days after each injection. Serious adverse events (SAEs) were collected throughout the trial.
Interventions
BIOLOGICALQuadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative
0.25 mL, Intramuscular
BIOLOGICALQuadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative
0.5 mL, Intramuscular
BIOLOGICALQuadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative
0.5 mL, Intramuscular
BIOLOGICALQuadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 6 months or older on the day of inclusion * For participants aged 6 to 35 months only: born at full term of pregnancy (\>=37 weeks) or birth weight \>=2.5 kg or both * Informed consent form had been signed and dated by the participants / participants' parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations. For participants aged 7 to 17 years of age, assent form has been signed and dated by the participants * Participants / participants' parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
* For participants aged 9 years or older only: participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) * Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination (except Oral Poliomyelitis Vaccine (OPV) received during national immunization days) * For participants aged 9 years or older only: previous vaccination against influenza (in the previous 9 months) with any influenza vaccine * For participants aged 6 months to 8 years only: previous priming with any influenza vaccine (i.e., participants who received 2 doses for at least 1 previous influenza season) * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; 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) * Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, after questioning * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * Self-reported thrombocytopenia or as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * For participants aged 9 years or older only: current alcohol abuse or drug addiction * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature \>=38.0 degree Celsius). A prospective participants should not be included in the study until the condition had resolved or the febrile event has subsided * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination) | Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. |
| Number of Participants With Seroprotection to Influenza Vaccine Antigens | Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination) | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer \>=40 (1/dilution\[dil\]) at pre-vaccination and at post-final vaccination. |
| Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | 28 days post-final vaccination (post-vaccination) | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<10 (1/dil) and post-vaccination titer \>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \>=10 (1/dil) and \>= 4-fold increase of post-vaccination titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Within 7 days after any vaccination | 1. Solicited injection site reactions: * Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:\>=50 mm) * Age \>=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities \[age 2-11 years\], significant interference with daily activities \[age \>=12 years\]; Erythema and Swelling \>=50 mm \[age 2-11 years\], \>100 mm \[age \>=12 years\]) 2. Solicited systemic reactions: * Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:\>39.5 degree Celsius; Vomiting:\>=6 episodes/24 hours; Crying abnormal:\>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses \>=3 feeds/meals or most feeds/meals; Irritability: inconsolable) * Age \>=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever\>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities) |
Countries
India
Participant flow
Recruitment details
Study participants were enrolled in 8 centers in India from 27 July 2015 to 26 November 2016.
Pre-assignment details
A total of 400 participants (100 in each group) were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28. | 99 |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28. | 98 |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0. | 99 |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0. | 100 |
| Total | 396 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Quadrivalent Influenza Vaccine Group 4: >=18 Years | Total | Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months |
|---|---|---|---|---|---|
| Age, Continuous | 4.9 years STANDARD_DEVIATION 1.5 | 11.7 years STANDARD_DEVIATION 2.2 | 48.5 years STANDARD_DEVIATION 18.8 | 16.6 years STANDARD_DEVIATION 21.2 | 1.0 years STANDARD_DEVIATION 0.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment India | 98 participants | 99 participants | 100 participants | 396 participants | 99 participants |
| Sex: Female, Male Female | 60 Participants | 50 Participants | 34 Participants | 189 Participants | 45 Participants |
| Sex: Female, Male Male | 38 Participants | 49 Participants | 66 Participants | 207 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 29 / 100 | 50 / 100 | 44 / 100 | 24 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Population: Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H1N1 | 14.4 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H3N2 | 44.4 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Victoria | 21.5 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Yamagata | 12.0 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H1N1 | 723 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H3N2 | 1016 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Victoria | 658 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Yamagata | 951 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H3N2 | 3458 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H1N1 | 1895 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H3N2 | 416 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Yamagata | 3582 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Victoria | 2222 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Yamagata | 81.1 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Victoria | 37.5 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H1N1 | 84.1 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Victoria | 2061 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Victoria | 54.1 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Yamagata | 91.7 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H1N1 | 1641 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H3N2 | 2379 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Yamagata | 2273 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H1N1 | 107 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H3N2 | 204 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Victoria | 41.9 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: B Yamagata | 107 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H3N2 | 20.8 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Pre-Vaccination: A/H1N1 | 44.3 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H1N1 | 1232 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Yamagata | 1836 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: B Victoria | 1150 Titers (1/dilutions) |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies | Post-Vaccination: A/H3N2 | 980 Titers (1/dilutions) |
Primary
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<10 (1/dil) and post-vaccination titer \>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \>=10 (1/dil) and \>= 4-fold increase of post-vaccination titer.
Time frame: 28 days post-final vaccination (post-vaccination)
Population: Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H3N2 | 85 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Victoria | 84 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H1N1 | 86 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Yamagata | 91 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H1N1 | 87 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H3N2 | 77 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Yamagata | 91 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Victoria | 87 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H1N1 | 84 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Yamagata | 86 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Victoria | 95 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H3N2 | 71 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Victoria | 92 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H3N2 | 90 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Yamagata | 86 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H1N1 | 90 Participants |
Primary
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer \>=40 (1/dilution\[dil\]) at pre-vaccination and at post-final vaccination.
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Population: Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H1N1 | 23 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H3N2 | 40 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Victoria | 30 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Yamagata | 18 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H1N1 | 93 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H3N2 | 96 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Victoria | 88 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Yamagata | 93 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H3N2 | 98 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H1N1 | 98 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H3N2 | 94 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Yamagata | 98 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Victoria | 98 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Yamagata | 65 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Victoria | 47 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H1N1 | 62 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Victoria | 98 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Victoria | 63 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Yamagata | 74 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H1N1 | 99 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H3N2 | 99 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Yamagata | 98 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H1N1 | 86 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H3N2 | 85 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Victoria | 53 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: B Yamagata | 83 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H3N2 | 34 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Pre-Vaccination: A/H1N1 | 60 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H1N1 | 99 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Yamagata | 97 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: B Victoria | 99 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Post-Vaccination: A/H3N2 | 96 Participants |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
1. Solicited injection site reactions: * Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:\>=50 mm) * Age \>=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities \[age 2-11 years\], significant interference with daily activities \[age \>=12 years\]; Erythema and Swelling \>=50 mm \[age 2-11 years\], \>100 mm \[age \>=12 years\]) 2. Solicited systemic reactions: * Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:\>39.5 degree Celsius; Vomiting:\>=6 episodes/24 hours; Crying abnormal:\>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses \>=3 feeds/meals or most feeds/meals; Irritability: inconsolable) * Age \>=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever\>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)
Time frame: Within 7 days after any vaccination
Population: Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, 'Number Analyzed' = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Drowsiness | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Drowsiness | 1 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Fever | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Myalgia | 1 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Crying abnormal | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Crying abnormal | 1 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Vomiting | 2 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Vomiting | 2 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Erythema | 1 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Pain / Tenderness | 12 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Malaise | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Malaise | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Shivering | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Headache | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Headache | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Swelling | 2 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3: Injection site Pain / Tenderness | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Irritability | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Irritability | 5 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Shivering | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Appetite lost | 0 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Appetite lost | 3 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Fever | 9 Participants |
| Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Myalgia | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Erythema | 3 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Pain / Tenderness | 40 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3: Injection site Pain / Tenderness | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Swelling | 3 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Fever | 8 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Fever | 2 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Irritability | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Headache | 4 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Headache | 1 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Malaise | 4 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Malaise | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Myalgia | 9 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Myalgia | 0 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Shivering | 2 Participants |
| Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Shivering | 1 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Erythema | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Pain / Tenderness | 35 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Myalgia | 16 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Shivering | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3: Injection site Pain / Tenderness | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Malaise | 7 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Myalgia | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Shivering | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Fever | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Erythema | 4 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Fever | 2 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Headache | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Malaise | 0 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Swelling | 4 Participants |
| Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Headache | 6 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Myalgia | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Pain / Tenderness | 24 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Headache | 1 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Headache | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Erythema | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Malaise | 1 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Shivering | 1 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Malaise | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3: Injection site Pain / Tenderness | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Myalgia | 3 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Shivering | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Fever | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Fever | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Swelling | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Injection site Swelling | 0 Participants |
| Quadrivalent Influenza Vaccine Group 4: >=18 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine | Grade 3 Injection site Erythema | 0 Participants |