Influenza, Swine-origin A/H1N1 Influenza
Conditions
Keywords
Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Children
Brief summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
Detailed description
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Interventions
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
BIOLOGICALNormal saline solution (placebo)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 9 Years
Healthy volunteers
Yes
Inclusion criteria
: All subjects: * Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years * Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures Subjects aged 3 to 9 years: * Healthy children aged 3 to 9 years on the day of inclusion Subjects aged 6 to 35 months: * Healthy infants and toddlers aged 6 to 35 months on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Exclusion criteria
: * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Receipt of any vaccine in the 4 weeks preceding the trial vaccination * Planned receipt of any vaccine prior to the Day 42 blood sample * Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances * Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator. * Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009 * Personal or family history of Guillain-Barré syndrome * Active neoplastic disease or a history of any hematologic malignancy * Known seizure/epilepsy history and/or taking anti-seizure medication * Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study * Febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-vaccination (Day 0) and 21 days post-vaccination | Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-vaccination (Day 0) and Day 21 post-vaccination | Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-vaccination (Day 0) and 21 days post-vaccination | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-vaccination (Day 0) and 21 days post-vaccination | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-vaccination (Day 0) and Day 21 post-vaccination | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-vaccination (Day 0) and Day 21 post-vaccination | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Days 0 to 7 post-vaccination | Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability. |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Days 0 to 7 post-vaccination | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering. |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Days 0 to 7 post vaccination | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.
Pre-assignment details
A total of 474 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participants by arm
| Arm | Count |
|---|---|
| A/H1N1 Vaccine Group 1 Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. | 215 |
| A/H1N1 Vaccine Group 2 Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. | 208 |
| Placebo Group Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | 51 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 7 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | A/H1N1 Vaccine Group 2 | Placebo Group | A/H1N1 Vaccine Group 1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 208 Participants | 51 Participants | 215 Participants | 474 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.3 Years STANDARD_DEVIATION 2.8 | 3.7 Years STANDARD_DEVIATION 2.7 | 4.1 Years STANDARD_DEVIATION 2.8 | 4.2 Years STANDARD_DEVIATION 2.8 |
| Region of Enrollment United States | 208 participants | 51 participants | 215 participants | 474 participants |
| Sex: Female, Male Female | 99 Participants | 24 Participants | 111 Participants | 234 Participants |
| Sex: Female, Male Male | 109 Participants | 27 Participants | 104 Participants | 240 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 110 / 219 | 104 / 204 | 27 / 51 |
| serious Total, serious adverse events | 1 / 219 | 0 / 204 | 1 / 51 |
Outcome results
Primary
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) GMT | 74.8 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1 (Day 0) GMT | 6.01 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) GMT | 459 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) GMT | 104 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1 (Day 0) GMT | 5.54 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) GMT | 586 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1 (Day 0) GMT | 11.9 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) GMT | 14.3 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) GMT | 12.1 Titers |
Primary
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) GMT | 33.3 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) GMT | 5.99 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) GMT | 368 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) GMT | 45.1 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) GMT | 5.48 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) GMT | 586 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) GMT | 5.00 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) GMT | 5.64 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) GMT | 5.08 Titers |
Primary
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil | 91 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil | 7 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil | 98 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil | 88 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil | 91 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil | 7 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil | 8 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil | 8 Participants |
Primary
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil | 72 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil | 90 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil | 79 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil | 87 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil | 0 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil | 1 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil | 0 Participants |
Primary
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil | 64 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil | 95 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil | 68 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil | 90 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil | 5 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil | 6 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil | 5 Participants |
Primary
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil | 43 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil | 84 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil | 42 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil | 86 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil | 0 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil | 1 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil | 0 Participants |
Primary
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Time frame: Days 0 to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Post Dose 1 | 12 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Solicited Injection Site Reaction - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Post Dose 1 | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) -Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade (Grd) 3 Injection Site Reaction - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Grade 3 Solicited Systemic Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Solicited Systemic Reaction - Any Dose | 14 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Post Dose 2 | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Post Dose 1 | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Malaise (Prevents daily activity) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Any Dose | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Any Dose | 17 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Post Dose 1 | 7 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Myalgia (Prevents Daily Activity) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Headache (Prevents daily activity) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Pain (Incapacitating) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Any Dose | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Solicited Injection Site Reaction - Any Dose | 20 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade (Grd) 3 Injection Site Reaction - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Post Dose 1 | 12 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Post Dose 2 | 16 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Pain (Incapacitating) - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Post Dose 1 | 7 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Post Dose 2 | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Any Dose | 12 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Post Dose 1 | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Solicited Systemic Reaction - Any Dose | 13 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Grade 3 Solicited Systemic Reaction - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) -Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Headache (Prevents daily activity) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Post Dose 1 | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Post Dose 2 | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Any Dose | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Malaise (Prevents daily activity) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Myalgia (Prevents Daily Activity) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Myalgia (Prevents Daily Activity) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Headache (Prevents daily activity) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Post Dose 1 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Swelling - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Post Dose 1 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Malaise - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Solicited Injection Site Reaction - Any Dose | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grd 3 Malaise (Prevents daily activity) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Shivering - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Post Dose 1 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Solicited Systemic Reaction - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade (Grd) 3 Injection Site Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Grade 3 Solicited Systemic Reaction - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Erythema - Post Dose 1 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Ecchymosis - Post Dose 1 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Pain (Incapacitating) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Fever - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Myalgia - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) -Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Pain - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Headache - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | Any Induration - Post Dose 2 | 1 Participants |
Primary
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Time frame: Days 0 to 7 post vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Any Dose | 23 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Post Dose 2 | 7 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Post Dose 1 | 48 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Post Dose 2 | 13 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Any Dose | 11 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Solicited Injection Site Reaction - Any Dose | 70 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Post Dose 1 | 15 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Induration (≥ 5 cm) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Post Dose 1 | 14 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Post Dose 1 | 9 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Injection Site Reaction - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Post Dose 2 | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Any Dose | 32 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Post Dose 2 | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Any Dose | 13 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Post Dose 2 | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Solicited Systemic Reaction - Any Dose | 51 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Post Dose 2 | 14 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Post Dose 2 | 34 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Post Dose 1 | 19 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Erythema (≥ 5 cm) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Malaise (Prevents daily activity) Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Post Dose 1 | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Any Dose | 29 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Any Dose | 63 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Post Dose 2 | 16 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Any Dose | 8 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Post Dose 1 | 18 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Swelling (≥ 5 cm) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Malaise (Prevents daily activity) Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Headache (Prevents daily activity) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Post Dose 1 | 7 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Pain (Incapacitating) - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Any Dose | 18 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Solicited Injection Site Reaction - Any Dose | 59 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Injection Site Reaction - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Post Dose 1 | 42 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Post Dose 2 | 31 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Any Dose | 54 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Pain (Incapacitating) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Post Dose 1 | 14 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Any Dose | 15 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Erythema (≥ 5 cm) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Post Dose 1 | 10 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Any Dose | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Swelling (≥ 5 cm) Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Post Dose 1 | 8 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Any Dose | 8 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Post Dose 1 | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Post Dose 2 | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Any Dose | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Solicited Systemic Reaction - Any Dose | 38 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 7 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Post Dose 1 | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Post Dose 2 | 10 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Headache (Prevents daily activity) Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Post Dose 1 | 12 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Post Dose 2 | 14 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Any Dose | 24 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Malaise (Prevents daily activity) Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Post Dose 1 | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Post Dose 2 | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Malaise (Prevents daily activity) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Any Dose | 8 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Post Dose 2 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Post Dose 1 | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Malaise (Prevents daily activity) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Any Dose | 7 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Post Dose 2 | 8 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Headache (Prevents daily activity) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Post Dose 1 | 7 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Post Dose 2 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Swelling - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Post Dose 1 | 12 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Malaise - Any Dose | 10 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Solicited Injection Site Reaction - Any Dose | 16 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Gr 3 Malaise (Prevents daily activity) Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Shivering - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Solicited Systemic Reaction - Any Dose | 12 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Injection Site Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Post Dose 2 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Erythema - Post Dose 1 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Ecchymosis - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Pain (Incapacitating) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Fever - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Myalgia - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Any Dose | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Pain - Any Dose | 16 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Headache - Post Dose 1 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years | Any Induration - Post Dose 2 | 0 Participants |
Primary
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Time frame: Days 0 to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade (Grd) 3 Injection Site Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Post Dose 1 | 24 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Post Dose 2 | 19 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Any Dose | 28 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grd 3 Tenderness-Crying or movement less, Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Post Dose 1 | 13 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Post Dose 2 | 12 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Post Dose 1 | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Solicited Injection Site Reaction - Any Dose | 33 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Post Dose 1 | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Post Dose 2 | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Solicited Systemic Reaction - Any Dose | 31 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Grade 3 Solicited Systemic Reaction - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Post Dose 1 | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Fever ( ≥102.1 ºF or ≥39.0 ºC) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Vomiting (> 6 episodes/24 hr) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Post Dose 1 | 17 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Post Dose 2 | 8 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Any Dose | 20 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Crying Abnormal (>3 hr) Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Post Dose 1 | 8 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Post Dose 2 | 8 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Any Dose | 11 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Drowsiness (Sleeps most of time) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Post Dose 1 | 8 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Any Dose | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grd 3 Appetite Lost (Refused 3 meals) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Post Dose 1 | 23 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Post Dose 2 | 14 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Any Dose | 26 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Irritability (Inconsolable) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Solicited Injection Site Reaction - Any Dose | 23 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Post Dose 1 | 12 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade (Grd) 3 Injection Site Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Post Dose 2 | 17 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Post Dose 1 | 14 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Post Dose 2 | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Post Dose 1 | 12 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Any Dose | 25 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Any Dose | 20 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Post Dose 2 | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grd 3 Tenderness-Crying or movement less, Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Any Dose | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Post Dose 1 | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Fever ( ≥102.1 ºF or ≥39.0 ºC) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grd 3 Appetite Lost (Refused 3 meals) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Any Dose | 14 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Any Dose | 7 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Solicited Systemic Reaction - Any Dose | 32 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Post Dose 1 | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Post Dose 2 | 7 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Post Dose 2 | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Post Dose 1 | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Crying Abnormal (>3 hr) Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Drowsiness (Sleeps most of time) Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Irritability (Inconsolable) Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Grade 3 Solicited Systemic Reaction - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Any Dose | 14 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Post Dose 1 | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Post Dose 1 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Vomiting (> 6 episodes/24 hr) Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Any Dose | 11 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Post Dose 1 | 22 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Induration (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Post Dose 1 | 7 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Ecchymosis - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Ecchymosis (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Irritability (Inconsolable) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Solicited Systemic Reaction - Any Dose | 11 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Grade 3 Solicited Systemic Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Drowsiness (Sleeps most of time) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Fever - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Post Dose 1 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Fever ( ≥102.1 ºF or ≥39.0 ºC) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Post Dose 2 | 6 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Vomiting - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Vomiting (> 6 episodes/24 hr) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Any Dose | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Solicited Injection Site Reaction - Any Dose | 11 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade (Grd) 3 Injection Site Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Appetite Lost - Post Dose 2 | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Post Dose 1 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Post Dose 1 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Post Dose 2 | 7 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Tenderness - Any Dose | 10 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grd 3 Tenderness-Crying or movement less, Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Post Dose 2 | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Erythema - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Crying Abnormal - Any Dose | 7 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Erythema (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grd 3 Appetite Lost (Refused 3 meals) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Crying Abnormal (>3 hr) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Swelling - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Irritability - Any Dose | 9 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Grade 3 Swelling (≥ 5 cm) Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Induration - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Any Drowsiness - Post Dose 1 | 3 Participants |