Influenza
Conditions
Keywords
Influenza, Trivalent Influenza Virus Vaccine, Quadrivalent Influenza Virus Vaccine
Brief summary
The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults. Observational Objectives: * To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age. * To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.
Interventions
BIOLOGICAL2009-2010 Trivalent Influenza Virus Vaccine
0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.
BIOLOGICAL2008-2009 Trivalent Influenza Virus Vaccine
0.25 mL, Intramuscular; 0.5 mL, Intramuscular.
BIOLOGICALQuadrivalent Influenza Virus Vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Subject is ≥ 6 months to \< 5 years of age or 18 years of age or older on the day of inclusion. * Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. * Subject in reasonably good health as assessed by the Investigator. * Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to give informed consent. * For subjects ≥ 6 months to \< 5 years of age: subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs). * For a woman, inability to bear a child or negative serum/urine pregnancy test, if applicable.
Exclusion criteria
: For all subjects: * History of allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde. * History of serious adverse reaction to any influenza vaccine. * Laboratory-confirmed influenza infection or vaccination against influenza in the six months preceding enrollment in the study. * Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3. * Participation in any other interventional drug or vaccine trial during participation in this study. * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. * Prior personal history of Guillain-Barré syndrome. For subjects \> 6 months to \< 5 years of age: * Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. * Personal or immediate family history of congenital immune deficiency. * Developmental delay, neurologic disorder, or seizure disorder. * Chronic medical, congenital, or developmental disorder. * Known HIV-positive mother. For subjects 18 years of age and older: * Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months. * Diabetes mellitus requiring pharmacological control. * Person deprived of freedom by an administrative or court order (having legal or medical guardian). * For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial. * Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures. * Any subject with the following conditions is not eligible for enrollment. However, the subject may be enrolled subsequently if the condition has resolved and enrollment is still ongoing and the subject meets all other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Day 0 up to 7 days post-vaccination | Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity. |
| Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | 21 Days post last vaccination | Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | 21 Days post last vaccination | Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | 21 Days post last vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 21 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil) |
| Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Day 0 (pre-vaccination) and Day 21 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil). |
| Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Day 0 up to 21 days post-vaccination | Seroconversion to vaccine antigens were defined as a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. |
| Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | 21 Days post last vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Day 21 post-vaccination | Seroconversion to vaccine antigens was defined as a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 01 October through 05 November 2009 in 4 clinical centers in the US.
Pre-assignment details
A total of 600 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV) | 220 |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV) | 190 |
| Study Group 3 (Quadrivalent Influenza Vaccine) Participants received the Quadrivalent Influenza Vaccine (QIV) | 190 |
| Total | 600 |
Baseline characteristics
| Characteristic | Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Study Group 3 (Quadrivalent Influenza Vaccine) | Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 30 Participants | 30 Participants |
| Age, Categorical >=65 years | 55 Participants | 67 Participants | 63 Participants | 185 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants | 123 Participants | 127 Participants | 385 Participants |
| Age Continuous | 54.9 Years STANDARD_DEVIATION 17.5 | 56.7 Years STANDARD_DEVIATION 17.2 | 47.8 Years STANDARD_DEVIATION 24.9 | 52.9 Years STANDARD_DEVIATION 20.8 |
| Region of Enrollment United States | 190 Participants | 190 Participants | 220 Participants | 600 Participants |
| Sex: Female, Male Female | 124 Participants | 130 Participants | 144 Participants | 398 Participants |
| Sex: Female, Male Male | 66 Participants | 60 Participants | 76 Participants | 202 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 | 105 / 220 | 84 / 190 | 91 / 190 |
| serious Total, serious adverse events | 0 / 220 | 0 / 190 | 2 / 190 |
Outcome results
Primary
Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: 21 Days post last vaccination
Population: Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | A/Brisbane/59/2007(A1N1) [N = 375, 0, 190] | 151 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | A/Uruguay/716/2007(H3N2) [N = 375, 0, 190] | 339 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | A/Brisbane/59/2007(A1N1) [N = 375, 0, 190] | 161 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | A/Uruguay/716/2007(H3N2) [N = 375, 0, 190] | 304 Titers |
Primary
Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: 21 Days post last vaccination
Population: Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | B/Brisbane/60/2008 (187, 0, 190) | 114 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | B/Florida/04/2006 (0, 188, 190) | NA Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | B/Brisbane/60/2008 (187, 0, 190) | NA Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | B/Florida/04/2006 (0, 188, 190) | 135 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | B/Brisbane/60/2008 (187, 0, 190) | 101 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. | B/Florida/04/2006 (0, 188, 190) | 155 Titers |
Primary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity.
Time frame: Day 0 up to 7 days post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (220, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Tenderness (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Appetite lost (15, 0, 0) | 1 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Pain (205, 190, 190) | 105 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Tenderness (15, 0, 0) | 4 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Appetite lost (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Shivering (190, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Drowsiness (15, 0, 0) | 4 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Crying abnormal (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Myalgia (205, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Drowsiness (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Myalgia (205, 190, 190) | 50 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Irritability (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Induration (190, 190, 190) | 3 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Irritability (15, 0, 0) | 5 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Erythema (220, 190, 190) | 7 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Crying abnormal (15, 0, 0) | 1 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Induration (190, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Shivering (190, 190, 190) | 10 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Ecchymosis (190, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Headache (205, 189, 190) | 1 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Malaise (205, 190, 190) | 3 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Fever (220, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (220, 190, 190) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Fever (220, 190, 190) | 2 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Vomiting (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (206, 190, 190) | 1 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Ecchymosis (190, 190, 190) | 1 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Vomiting (15, 0, 0) | 0 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Swelling (220, 190, 190) | 10 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Malaise (205, 190, 190) | 30 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Headache (205, 189, 190) | 35 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Tenderness (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (206, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Erythema (220, 190, 190) | 3 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (220, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (220, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Induration (190, 190, 190) | 1 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Induration (190, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Ecchymosis (190, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Fever (220, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Vomiting (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Malaise (205, 190, 190) | 23 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Malaise (205, 190, 190) | 1 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Appetite lost (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Drowsiness (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Crying abnormal (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Headache (205, 189, 190) | 34 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Headache (205, 189, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Irritability (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Shivering (190, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Tenderness (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Pain (205, 190, 190) | 82 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Swelling (220, 190, 190) | 2 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Ecchymosis (190, 190, 190) | 1 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Fever (220, 190, 190) | 1 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Vomiting (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Appetite lost (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Drowsiness (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Crying abnormal (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Irritability (15, 0, 0) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Myalgia (205, 190, 190) | 32 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Myalgia (205, 190, 190) | 0 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Shivering (190, 190, 190) | 6 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Induration (190, 190, 190) | 1 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Tenderness (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Pain (205, 190, 190) | 90 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (206, 190, 190) | 1 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Vomiting (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (220, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Swelling (220, 190, 190) | 1 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Induration (190, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Vomiting (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (220, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Ecchymosis (190, 190, 190) | 1 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Injection site Ecchymosis (190, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Fever (220, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Headache (205, 189, 190) | 30 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Erythema (220, 190, 190) | 2 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Malaise (205, 190, 190) | 20 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Fever (220, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Headache (205, 189, 190) | 1 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Crying abnormal (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Irritability (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Crying abnormal (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Irritability (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Drowsiness (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Drowsiness (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Myalgia (205, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Shivering (190, 190, 190) | 5 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Appetite lost (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Myalgia (205, 190, 190) | 45 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Shivering (190, 190, 190) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Appetite lost (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Injection site Tenderness (15, 0, 0) | 0 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. | Grade 3 Malaise (205, 190, 190) | 2 Participants |
Other Pre-specified
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: 21 Days post last vaccination
Population: Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H3N2, Pre-vaccination (186, 188, 190) | 29.9 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Florida/04/2006, Post-vaccination (0, 187, 190) | NA Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) | 22.0 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H3N2, Post-vaccination (187, 188, 190) | 302 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Florida/04/2006, Pre-vaccination (0, 187, 190) | NA Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H1N1, Post-vaccination (187, 188, 190) | 145 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H1N1, Pre-vaccination (186, 188, 190) | 27.5 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Brisbane/60/2008, Post-vaccination (187, 0, 190) | 114 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Brisbane/60/2008, Post-vaccination (187, 0, 190) | NA Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H1N1, Pre-vaccination (186, 188, 190) | 28.4 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H1N1, Post-vaccination (187, 188, 190) | 157 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H3N2, Pre-vaccination (186, 188, 190) | 32.7 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H3N2, Post-vaccination (187, 188, 190) | 380 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) | NA Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Florida/04/2006, Pre-vaccination (0, 187, 190) | 32.6 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Florida/04/2006, Post-vaccination (0, 187, 190) | 135 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) | 19.9 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H1N1, Post-vaccination (187, 188, 190) | 161 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H1N1, Pre-vaccination (186, 188, 190) | 27.6 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Florida/04/2006, Post-vaccination (0, 187, 190) | 155 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Florida/04/2006, Pre-vaccination (0, 187, 190) | 27.1 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H3N2, Post-vaccination (187, 188, 190) | 304 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | A/H3N2, Pre-vaccination (186, 188, 190) | 38.5 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants | B/Brisbane/60/2008, Post-vaccination (187, 0, 190) | 101 Titers |
Other Pre-specified
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: 21 Days post last vaccination
Population: Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Florida/04/2006, Post-vaccination (0, 187, 189) | NA Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H3N2, Post-vaccination (214, 188, 189) | 285 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H3N2, Pre-vaccination (214, 187, 189) | 30.5 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H1N1, Pre-vaccination (214, 186, 189) | 27.0 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) | 15.5 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Brisbane/60/2008, Post-vaccination (215, 0, 189) | 76.7 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H1N1, Post-vaccination (214, 187, 189) | 153 Titers |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Florida/04/2006, Pre-vaccination (0, 186, 189) | NA Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Florida/04/2006, Pre-vaccination (0, 186, 189) | 26.6 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H1N1, Post-vaccination (214, 187, 189) | 145 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H1N1, Pre-vaccination (214, 186, 189) | 27.8 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) | NA Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H3N2, Post-vaccination (214, 188, 189) | 330 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Florida/04/2006, Post-vaccination (0, 187, 189) | 96.5 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H3N2, Pre-vaccination (214, 187, 189) | 34.6 Titers |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Brisbane/60/2008, Post-vaccination (215, 0, 189) | NA Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Florida/04/2006, Pre-vaccination (0, 186, 189) | 21.7 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H1N1, Pre-vaccination (214, 186, 189) | 25.4 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H1N1, Post-vaccination (214, 187, 189) | 143 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Brisbane/60/2008, Post-vaccination (215, 0, 189) | 75.6 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Florida/04/2006, Post-vaccination (0, 187, 189) | 109 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H3N2, Pre-vaccination (214, 187, 189) | 37.8 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | A/H3N2, Post-vaccination (214, 188, 189) | 263 Titers |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants | B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) | 16.2 Titers |
Other Pre-specified
Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Seroconversion to vaccine antigens was defined as a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 21 post-vaccination
Population: Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 (187, 188, 190) | 103 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 (0, 188, 190) | NA Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 (187, 0, 190) | 104 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 (187, 188, 190) | 130 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 (0, 188, 190) | 83 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 (187, 0, 190) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 (187, 188, 190) | 120 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 (187, 188, 190) | 97 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 (187, 0, 190) | 101 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 (187, 188, 190) | 119 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 (187, 188, 190) | 112 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 (0, 188, 190) | 110 Participants |
Other Pre-specified
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)
Time frame: Day 0 (pre-vaccination) and Day 21 post final vaccination
Population: Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H3N2, Pre-vaccination (186, 187, 190) | 83 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Florida/04/2006, Post-vaccination (0, 187, 190) | NA Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H3N2, Post-vaccination (187, 188, 190) | 180 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Florida/04/2006, Pre-vaccination (0, 187, 190) | NA Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H1N1, Post-vaccination (187, 188, 190) | 168 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) | 80 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H1N1, Pre-vaccination (186, 188, 190) | 84 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Brisbane/60/2008, Post-vaccination (187, 0, 190) | 168 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Brisbane/60/2008, Post-vaccination (187, 0, 190) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Florida/04/2006, Pre-vaccination (0, 187, 190) | 97 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Florida/04/2006, Post-vaccination (0, 187, 190) | 174 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H1N1, Pre-vaccination (186, 188, 190) | 77 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H3N2, Pre-vaccination (186, 187, 190) | 91 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H1N1, Post-vaccination (187, 188, 190) | 173 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H3N2, Post-vaccination (187, 188, 190) | 177 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) | NA Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Florida/04/2006, Post-vaccination (0, 187, 190) | 175 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H1N1, Pre-vaccination (186, 188, 190) | 81 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H1N1, Post-vaccination (187, 188, 190) | 176 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H3N2, Pre-vaccination (186, 187, 190) | 93 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | A/H3N2, Post-vaccination (187, 188, 190) | 180 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) | 69 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Brisbane/60/2008, Post-vaccination (187, 0, 190) | 162 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine | B/Florida/04/2006, Pre-vaccination (0, 187, 190) | 89 Participants |
Other Pre-specified
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Seroconversion to vaccine antigens were defined as a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 0 up to 21 days post-vaccination
Population: Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 Pre-vaccination (214, 0, 189) | 57 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 Pre-vaccination (214, 186, 189) | 88 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 Post-vaccination (213, 187, 189) | 148 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 Pre-vaccination (0, 186, 189) | NA Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 Post-vaccination (214, 0, 189) | 111 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 Post-vaccination (0, 186, 189) | NA Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 Pre-vaccination (214, 187, 189) | 100 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 Post-vaccination (213, 186, 189) | 118 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 Post-vaccination (214, 0, 189) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 Pre-vaccination (214, 186, 189) | 71 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 Post-vaccination (213, 186, 189) | 90 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 Pre-vaccination (214, 187, 189) | 94 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 Pre-vaccination (214, 0, 189) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 Pre-vaccination (0, 186, 189) | 80 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 Post-vaccination (0, 186, 189) | 79 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 Post-vaccination (213, 187, 189) | 119 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 Post-vaccination (0, 186, 189) | 100 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 Pre-vaccination (214, 187, 189) | 92 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 Post-vaccination (214, 0, 189) | 99 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 Pre-vaccination (214, 186, 189) | 70 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2 Post-vaccination (213, 187, 189) | 116 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008 Pre-vaccination (214, 0, 189) | 50 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006 Pre-vaccination (0, 186, 189) | 67 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1 Post-vaccination (213, 186, 189) | 112 Participants |
Other Pre-specified
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil).
Time frame: Day 0 (pre-vaccination) and Day 21 post final vaccination
Population: Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2, Post-vaccination (214, 188, 189) | 209 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006, Post-vaccination (0, 187, 189) | NA Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1, Pre-vaccination (214, 186, 189) | 88 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2, Pre-vaccination (214, 187, 189) | 100 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) | 57 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008, Post-vaccination (215, 0, 189) | 172 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1, Post-vaccination (214, 187, 189) | 193 Participants |
| Study Group 1 (2009-2010 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006, Pre-vaccination (0, 186, 189) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008, Post-vaccination (215, 0, 189) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) | NA Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2, Pre-vaccination (214, 187, 189) | 94 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1, Pre-vaccination (214, 186, 189) | 71 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1, Post-vaccination (214, 187, 189) | 168 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2, Post-vaccination (214, 188, 189) | 179 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006, Post-vaccination (0, 187, 189) | 164 Participants |
| Study Group 2 (2008-2009 Trivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006, Pre-vaccination (0, 186, 189) | 80 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006, Post-vaccination (0, 187, 189) | 169 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2, Pre-vaccination (214, 187, 189) | 92 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H3N2, Post-vaccination (214, 188, 189) | 179 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) | 50 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Brisbane/60/2008, Post-vaccination (215, 0, 189) | 153 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | B/Florida/04/2006, Pre-vaccination (0, 186, 189) | 67 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1, Post-vaccination (214, 187, 189) | 169 Participants |
| Study Group 3 (Quadrivalent Influenza Vaccine) | Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | A/H1N1, Pre-vaccination (214, 186, 189) | 70 Participants |