Influenza
Conditions
Keywords
Influenza, Quadrivalent influenza vaccine, Trivalent influenza vaccine
Brief summary
The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety. Objectives: * To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed. * To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations
Detailed description
All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for safety and immunogenicity for up to Day 21 post-vaccination.
Interventions
BIOLOGICALQuadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016
0.5 mL, Intramuscular
BIOLOGICALTrivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 60 years on the day of inclusion * Subjects aged 18 years: Assent form has been signed and dated by the subject or by an independent witness, and informed consent form has been signed and dated by at least one parent or another legally acceptable representative or by an independent witness Subjects aged 19 to 60 years: Informed consent form has been signed and dated by the subject or by an independent witness * Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
* Subject is 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 3 weeks after vaccination) * Participation at the time of study enrollment (or in the 4 weeks preceding the 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 trial vaccination or planned receipt of any vaccine until the second visit, 3 weeks following the trial vaccination * Vaccination against influenza if administered in the context of a clinical trial or a flu vaccination campaign or self-reported history of influenza infection (influenza-like illness) in the previous 6 months * 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) * Known history of seropositivity for Human Immunodeficiency Virus (HIV) or Hepatitis C * Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances * Known or suspected thrombocytopenia, contraindicating intramuscular vaccination, based on Investigator's judgment * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, based on Investigator's judgment * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction * Chronic illness that, in the opinion of the investigator, is 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 (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has 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 of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. |
| Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21. |
| Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. |
| Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 21 post-vaccination | Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21. |
| Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. |
| Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 0 up Day 3 post-vaccination | The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature \>38.0˚C for at least 1 day), Malaise, and Shivering (rigors). |
| Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Day 0 up Day 7 post-vaccination | Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. |
Countries
South Korea
Participant flow
Recruitment details
The study participants were enrolled from 11 September 2015 to 03 November 2015 at 5 clinic sites in the Republic of Korea.
Pre-assignment details
A total of 300 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Quadrivalent Influenza Vaccine Group Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route. | 200 |
| Trivalent Influenza Vaccine Group Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route. | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | Trivalent Influenza Vaccine Group | Quadrivalent Influenza Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 200 Participants | 300 Participants |
| Age, Continuous Age Continuous | 35.6 Years STANDARD_DEVIATION 9.5 | 35.9 Years STANDARD_DEVIATION 9.1 | 35.8 Years STANDARD_DEVIATION 9.2 |
| Region of Enrollment Korea, Republic of | 100 Participants | 200 Participants | 300 Participants |
| Sex: Female, Male Female | 71 Participants | 150 Participants | 221 Participants |
| Sex: Female, Male Male | 29 Participants | 50 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 141 / 200 | 64 / 100 |
| serious Total, serious adverse events | 0 / 200 | 0 / 100 |
Outcome results
Primary
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Geometric mean titer ratios of influenza antibodies were assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1 (N=199, 99) | 4.10 Titer ratio |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2 (N=199, 99) | 11.6 Titer ratio |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket (N=199, 99) | 4.17 Titer ratio |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris (N=199, 100) | 3.97 Titer ratio |
| Trivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris (N=199, 100) | 2.08 Titer ratio |
| Trivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1 (N=199, 99) | 5.64 Titer ratio |
| Trivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket (N=199, 99) | 5.04 Titer ratio |
| Trivalent Influenza Vaccine Group | Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2 (N=199, 99) | 19.3 Titer ratio |
Primary
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 0 (N=199, 99) | 142 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 21 (N=199, 100) | 737 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 21 (N=199, 99) | 583 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 0 (N=199, 99) | 41.6 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 21 (N=199, 99) | 483 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 0 (N=199, 99) | 256 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 21 (N=199, 99) | 1068 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 0 (N=199, 100) | 186 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 0 (N=199, 100) | 139 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 0 (N=199, 99) | 116 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 21 (N=199, 99) | 691 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 21 (N=199, 100) | 290 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 21 (N=199, 99) | 1105 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 21 (N=199, 99) | 651 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 0 (N=199, 99) | 219 Titers (1/dilution) |
| Trivalent Influenza Vaccine Group | Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 0 (N=199, 99) | 35.8 Titers (1/dilution) |
Primary
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
Time frame: Day 21 post-vaccination
Population: Immunogenicity was assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1 (N=199, 99) | 39.7 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2 (N=199, 99) | 72.4 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket (N=199, 99) | 48.7 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris (N=199, 100) | 46.2 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris (N=199, 100) | 23.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1 (N=199, 99) | 46.5 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket (N=199, 99) | 53.5 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2 (N=199, 99) | 84.8 Percentage of Participants |
Primary
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Seroprotection was assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 0 (N=199, 99) | 83.4 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 21 (N=199, 99) | 99.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 0 (N=199, 99) | 56.3 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 21 (N=199, 99) | 98.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 0 (N=199, 99) | 91.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 21 (N=199, 99) | 100.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 0 (N=199, 100) | 89.4 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 21 (N=199, 100) | 100.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 21 (N=199, 99) | 99.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 0 (N=199, 99) | 78.8 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 21 (N=199, 100) | 97.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 21 (N=199, 99) | 100.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 21 (N=199, 99) | 100.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 0 (N=199, 99) | 87.9 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 0 (N=199, 99) | 55.6 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 0 (N=199, 100) | 85.0 Percentage of Participants |
Primary
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.
Time frame: Day 0 up Day 7 post-vaccination
Population: Solicited injection-site and systemic reactions were analyzed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Pain | 1.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Erythema | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Swelling | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Fever | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Malaise | 33.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Pain | 70.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Erythema | 2.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Swelling | 3.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Induration | 3.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Induration | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Ecchymosis | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Ecchymosis | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Fever | 0.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Headache | 16.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Headache | 1.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Malaise | 1.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Myalgia | 51.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Myalgia | 1.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Shivering | 6.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Shivering | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Induration | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Pain | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Myalgia | 49.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Ecchymosis | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Shivering | 6.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Headache | 2.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Ecchymosis | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Malaise | 42.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Shivering | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Malaise | 1.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Pain | 64.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Fever | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Erythema | 3.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Erythema | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Fever | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Swelling | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Injection-site Swelling | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Grade 3 Myalgia | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Injection-site Induration | 2.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Any Headache | 20.0 Percentage of Participants |
Primary
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature \>38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
Time frame: Day 0 up Day 3 post-vaccination
Population: Solicited reactions were analyzed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Injection site Ecchymosis (Inj. site Bruising) | 6.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Reaction listed in the EMA note for guidance | 34.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Pyrexia (temperature >38.0˚C for at least 1 day) | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Injection site Induration (≥50 mm for 4 days) | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Malaise | 31.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Shivering (Rigors) | 5.5 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Shivering (Rigors) | 6.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Injection site Induration (≥50 mm for 4 days) | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Injection site Ecchymosis (Inj. site Bruising) | 4.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Reaction listed in the EMA note for guidance | 40.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Pyrexia (temperature >38.0˚C for at least 1 day) | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | Malaise | 40.0 Percentage of Participants |
Primary
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Immunogenicity was assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 0 (N=199, 99) | 5.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 21 (N=199, 99) | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 21 (N=199, 100) | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 0 (N=199, 99) | 17.1 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 21 (N=199, 99) | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 0 (N=199, 99) | 1.5 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 21 (N=199, 99) | 0.0 Percentage of Participants |
| Quadrivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 0 (N=199, 100) | 0.5 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 0 (N=199, 99) | 20.2 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 0 (N=199, 99) | 6.1 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 0 (N=199, 99) | 1.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 0 (N=199, 100) | 2.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H3N2; Day 21 (N=199, 99) | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Bris; Day 21 (N=199, 100) | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | A/H1N1; Day 21 (N=199, 99) | 0.0 Percentage of Participants |
| Trivalent Influenza Vaccine Group | Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route | B/Phuket; Day 21 (N=199, 99) | 0.0 Percentage of Participants |