Influenza
Conditions
Keywords
Influenza, Trivalent influenza vaccine, Sanofi Pasteur Shenzhen trivalent influenza vaccine
Brief summary
The main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV). Primary objective: * To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV. Secondary objective: * To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).
Detailed description
Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months).
Interventions
BIOLOGICALShenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
0.25 mL Intramuscular (2 doses given 28 days apart)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_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 on the day of inclusion * Informed Consent Form has been signed and dated: * by the parent(s) or legally acceptable representative, if applicable, for subjects \<18 years of age. Additionally, an assent form has been signed by the subject if aged 10 to 17 years (based on local regulations). * by the subject himself/herself for subjects ≥18 years of age. * Subject and parent(s)/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures * For subjects aged 6-35 months only: Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * For subjects aged 3-8 years only: Subject has previously received at least one dose of influenza vaccine in the past years or has a history of prior exposure to influenza virus through natural infection.
Exclusion criteria
* Subject is pregnant (positive urine pregnancy test), 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 or planned receipt of any vaccine within the period from 2 weeks before to 2 weeks after trial vaccination (subjects aged ≥3 years) or within the period from 2 weeks before the first trial vaccination to 2 weeks after the second trial vaccination (subjects aged 6-35 months) * For subjects aged 6-35 months only: Previous vaccination against influenza (i.e. 2 consecutive doses of influenza vaccine \[same seasonal strain composition\]) any time prior to study enrollment or history of prior exposure to influenza virus through natural infection * Vaccination against influenza given in the past 6 months with any influenza vaccine or planned receipt of influenza vaccination during the present study * Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response * 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) * Reported history of seropositivity for Human Immunodeficiency Virus (HIV), after questioning the subject or the subject's parents or another legally acceptable representative * 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 vaccine used in the study or to a vaccine containing any of the same substance * Self-reported thrombocytopenia, as reported by the subject, parent or legally acceptable representative contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination upon 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 that might interfere with the ability to comply with trial procedures * 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 (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * 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 Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination | Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination | Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56. |
| Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination | Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56. |
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Day 0 up to Day 7 post any vaccination | Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years). Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever \>39.5˚C; Crying abnormal - \>3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years) |
Countries
China
Participant flow
Recruitment details
The study participants were enrolled from 05 September 2014 to 09 October 2014 at 1 clinical center at the Province of Guangxi China.
Pre-assignment details
A total of 602 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Age 6 to 35 Months Group Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart. | 150 |
| Age 3 to 17 Years Group Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated). | 150 |
| Age 18 to 60 Years Group Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated). | 151 |
| Age ≥61 Years Group Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated). | 151 |
| Total | 602 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 7 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 2 | 3 |
Baseline characteristics
| Characteristic | Age 3 to 17 Years Group | Age 18 to 60 Years Group | Age 6 to 35 Months Group | Age ≥61 Years Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 150 Participants | 0 Participants | 150 Participants | 0 Participants | 300 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 110 Participants | 110 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 151 Participants | 0 Participants | 41 Participants | 192 Participants |
| Age, Continuous | 8.55 Years STANDARD_DEVIATION 3.09 | 46.5 Years STANDARD_DEVIATION 11.2 | 1.45 Years STANDARD_DEVIATION 0.597 | 69.8 Years STANDARD_DEVIATION 6.37 | 31.5 Years STANDARD_DEVIATION 5.31425 |
| Region of Enrollment China | 150 Participants | 151 Participants | 150 Participants | 151 Participants | 602 Participants |
| Sex: Female, Male Female | 70 Participants | 114 Participants | 68 Participants | 79 Participants | 331 Participants |
| Sex: Female, Male Male | 80 Participants | 37 Participants | 82 Participants | 72 Participants | 271 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 38 / 150 | 52 / 150 | 25 / 151 | 12 / 151 |
| serious Total, serious adverse events | 1 / 150 | 1 / 150 | 0 / 151 | 1 / 151 |
Outcome results
Primary
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Population: Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 6 to 35 Months Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 12.8 Titers (1/dilution) |
| Age 6 to 35 Months Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 152.2 Titers (1/dilution) |
| Age 6 to 35 Months Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; n=150,150,151,151) | 14.3 Titers (1/dilution) |
| Age 6 to 35 Months Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 235.9 Titers (1/dilution) |
| Age 6 to 35 Months Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 5.9 Titers (1/dilution) |
| Age 6 to 35 Months Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 108.5 Titers (1/dilution) |
| Age 3 to 17 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 216.8 Titers (1/dilution) |
| Age 3 to 17 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 236.2 Titers (1/dilution) |
| Age 3 to 17 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 24.3 Titers (1/dilution) |
| Age 3 to 17 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; n=150,150,151,151) | 62 Titers (1/dilution) |
| Age 3 to 17 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 300.7 Titers (1/dilution) |
| Age 3 to 17 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 17.7 Titers (1/dilution) |
| Age 8 to 60 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 188.3 Titers (1/dilution) |
| Age 8 to 60 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; n=150,150,151,151) | 12.2 Titers (1/dilution) |
| Age 8 to 60 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 166.1 Titers (1/dilution) |
| Age 8 to 60 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 202.8 Titers (1/dilution) |
| Age 8 to 60 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 16.3 Titers (1/dilution) |
| Age 8 to 60 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 11.2 Titers (1/dilution) |
| Age ≥61 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 15.3 Titers (1/dilution) |
| Age ≥61 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 170 Titers (1/dilution) |
| Age ≥61 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 144 Titers (1/dilution) |
| Age ≥61 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 237.8 Titers (1/dilution) |
| Age ≥61 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 9 Titers (1/dilution) |
| Age ≥61 Years Group | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; n=150,150,151,151) | 21.1 Titers (1/dilution) |
Other Pre-specified
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years). Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever \>39.5˚C; Crying abnormal - \>3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)
Time frame: Day 0 up to Day 7 post any vaccination
Population: Solicited injection site and systemic reactions were assessed in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Ecchymosis (N=140,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Irritability (N=69,0,0,0) | 14 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Shivering (N=70,148,150,151) | 1 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Headache (N=70,148,150,151) | 1 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Drowsiness (N=69,0,0,0) | 12 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Shivering (N=70,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection-site Swelling (n=140,148,150,151) | 4 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Fever (N=138,148,149,150) | 38 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Malaise (N=70,148,150,151) | 1 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Appetite lost (N=69,0,0,0) | 4 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Crying abnormal (N=69,0,0,0) | 20 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Crying abnormal (N=69,0,0,0) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Erythema (N=140,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Tenderness/Pain (N=140,148,150,151) | 38 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Ecchymosis (N=140,148,150,151) | 1 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Vomiting (N =69,0,0,0) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Myalgia (N=70,148,150,151) | 4 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Headache (N=70,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Appetite lost (N=69,0,0,0) | 20 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Swelling (n=140,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Malaise (N=70,148,150,151) | 5 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Erythema (N=140,148,150,151) | 2 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Vomiting (N=69,0,0,0) | 9 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Induration (N=140,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Tenderness/Pain (N=140,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Induration (N=140,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Drowsiness (N=69,0,0,0) | 1 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Irritability (N=69,0,0,0) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Myalgia (N=70,148,150,151) | 0 Participants |
| Age 6 to 35 Months Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Fever (N=138,148,149,150) | 1 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Vomiting (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Erythema (N=140,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection-site Swelling (n=140,148,150,151) | 5 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Malaise (N=70,148,150,151) | 11 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Fever (N=138,148,149,150) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Induration (N=140,148,150,151) | 3 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Induration (N=140,148,150,151) | 1 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Ecchymosis (N=140,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Ecchymosis (N=140,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Fever (N=138,148,149,150) | 22 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Malaise (N=70,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Irritability (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Myalgia (N=70,148,150,151) | 16 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Shivering (N=70,148,150,151) | 6 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Myalgia (N=70,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Irritability (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Appetite lost (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Crying abnormal (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Shivering (N=70,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Headache (N=70,148,150,151) | 8 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Crying abnormal (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Vomiting (N =69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Appetite lost (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Tenderness/Pain (N=140,148,150,151) | 52 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Swelling (n=140,148,150,151) | 2 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Headache (N=70,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Drowsiness (N=69,0,0,0) | NA Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Tenderness/Pain (N=140,148,150,151) | 0 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Erythema (N=140,148,150,151) | 2 Participants |
| Age 3 to 17 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Drowsiness (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Myalgia (N=70,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Induration (N=140,148,150,151) | 2 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Ecchymosis (N=140,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Headache (N=70,148,150,151) | 6 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Headache (N=70,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Malaise (N=70,148,150,151) | 6 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Malaise (N=70,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Myalgia (N=70,148,150,151) | 5 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Shivering (N=70,148,150,151) | 3 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Shivering (N=70,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Crying abnormal (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Tenderness/Pain (N=140,148,150,151) | 25 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Swelling (n=140,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Tenderness/Pain (N=140,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Erythema (N=140,148,150,151) | 3 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Erythema (N=140,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection-site Swelling (n=140,148,150,151) | 2 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Induration (N=140,148,150,151) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Ecchymosis (N=140,148,150,151) | 2 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Fever (N=138,148,149,150) | 6 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Fever (N=138,148,149,150) | 0 Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Crying abnormal (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Drowsiness (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Drowsiness (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Appetite lost (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Appetite lost (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Irritability (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Irritability (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Vomiting (N=69,0,0,0) | NA Participants |
| Age 8 to 60 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Vomiting (N =69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Malaise (N=70,148,150,151) | 5 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Drowsiness (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Tenderness/Pain (N=140,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Swelling (n=140,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Headache (N=70,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Drowsiness (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Tenderness/Pain (N=140,148,150,151) | 12 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Crying abnormal (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Vomiting (N =69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Appetite lost (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Shivering (N=70,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Shivering (N=70,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Vomiting (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Appetite lost (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Myalgia (N=70,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Headache (N=70,148,150,151) | 4 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Induration (N=140,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Irritability (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Myalgia (N=70,148,150,151) | 1 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Ecchymosis (N=140,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Malaise (N=70,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Fever (N=138,148,149,150) | 5 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Ecchymosis (N=140,148,150,151) | 1 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection-site Swelling (n=140,148,150,151) | 1 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Induration (N=140,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Fever (N=138,148,149,150) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Irritability (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Crying abnormal (N=69,0,0,0) | NA Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Grade 3 Inj. site Erythema (N=140,148,150,151) | 0 Participants |
| Age ≥61 Years Group | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine | Injection site Erythema (N=140,148,150,151) | 1 Participants |
Other Pre-specified
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.
Time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Population: Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 to 35 Months Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (N=125,145,149,145) | 86.4 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (N=123,146,149,148) | 93.5 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (N=125,146,149,147) | 90.4 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (N=125,145,149,145) | 79.3 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (N=123,146,149,148) | 82.2 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (N=125,146,149,147) | 56.2 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (N=125,146,149,147) | 83.2 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (N=125,145,149,145) | 91.3 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (N=123,146,149,148) | 85.9 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (N=125,145,149,145) | 84.1 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (N=123,146,149,148) | 80.4 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (N=125,146,149,147) | 78.2 Percentage of participants |
Other Pre-specified
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.
Time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Population: Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 to 35 Months Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 1.3 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 88.8 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 93.5 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; N=150,150,151,151) | 32.0 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 98.4 Percentage of participants |
| Age 6 to 35 Months Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 31.3 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; N=150,150,151,151) | 78.0 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 45.3 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 30.0 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 99.3 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 95.2 Percentage of participants |
| Age 3 to 17 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 94.5 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 98.7 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 96.6 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 95.3 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; N=150,150,151,151) | 21.9 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 17.2 Percentage of participants |
| Age 8 to 60 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 29.8 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Pre-dose; N=150,150,151,151) | 39.1 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Pre-dose; N=150,150,151,151) | 14.6 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H1N1 (Post-dose; N=125,145,149,145) | 89.7 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Post-dose; N=123,146,149,148) | 93.9 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | A/H3N2 (Post-dose; N=125,146,149,147) | 95.9 Percentage of participants |
| Age ≥61 Years Group | Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine | B (Pre-dose; N=150,150,151,151) | 23.8 Percentage of participants |