Influenza
Conditions
Keywords
Influenza, Quadrivalent Inactivated Influenza Vaccine
Brief summary
The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan Primary Objective: * To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation Secondary Objective: * To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation
Detailed description
Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 9 to 17 years on the day of inclusion * Assent form (AF) and/or informed consent form (ICF) have been signed and dated by the subject according to each site requirements, and ICF has been signed and dated by the parent(s) or another legally acceptable representative(s) and by an independent witness if applicable * Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Subject is pregnant (or positive urine pregnancy test), or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) * Participation at the time of study enrollment or in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination * Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or in the previous 6 months if administered in the context of a flu vaccination campaign * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, after questioning * Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances * Known or suspected thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination upon investigator's judgment * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * Identified as a family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. |
| Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination. |
| Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | Day 21 post-vaccination | Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer. |
| Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 21 post-vaccination | Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. |
| Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Day 0 up to Day 7 post-vaccination | Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \> 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. |
Countries
Taiwan
Participant flow
Recruitment details
Study participants were enrolled from 18 October 2013 to 19 November 2013 at 2 clinical sites in Taiwan.
Pre-assignment details
A total of 100 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Quadrivalent Influenza Vaccine Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Quadrivalent Influenza Vaccine |
|---|---|
| Age, Categorical <=18 years | 100 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous Age Continuous | 13.4 Years STANDARD_DEVIATION 2.9 |
| Region of Enrollment Taiwan | 100 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 56 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Geometric mean titers were analyzed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/California/07/2009 (H1N1); Pre-dose | 257 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/California/07/2009 (H1N1); Post-dose | 589 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/Texas/50/2012 (H3N2); Pre-dose | 382 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/Texas/50/2012 (H3N2); Post-dose | 782 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Massachusetts/2/2012; Pre-dose | 497 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Massachusetts/2/2012; Post-dose | 1654 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Brisbane/60/2008; Pre-dose | 186 Titers (1/dilution) |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Brisbane/60/2008; Post-dose | 856 Titers (1/dilution) |
Primary
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | A/California/07/2009 (H1N1) | 2.29 Titers ratio |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | A/Texas/50/2012 (H3N2) | 2.05 Titers ratio |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | B/Massachusetts/2/2012 | 3.33 Titers ratio |
| Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine | B/Brisbane/60/2008 | 4.59 Titers ratio |
Primary
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \> 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Injection-site Pain | 56.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Injection-site Pain | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Injection-site Erythema | 6.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Injection-site Erythema | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Injection-site Swelling | 4.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Injection-site Swelling | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Injection-site Induration | 2.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Injection-site Induration | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Injection-site Ecchymosis | 1.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Injection-site Ecchymosis | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Fever | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Fever | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Headache | 8.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Headache | 0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Malaise | 15.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Malaise | 1.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Myalgia | 45.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Myalgia | 1.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Shivering | 3.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine | Grade 3 Shivering | 0 Percentage of participants |
Primary
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Time frame: Day 21 post-vaccination
Population: Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | A/California/07/2009 (H1N1) | 24.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | A/Texas/50/2012 (H3N2) | 20.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | B/Massachusetts/2/2012 | 39.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine | B/Brisbane/60/2008 | 48.0 Percentage of participants |
Primary
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Population: Seroprotection was analyzed in the Immunogenicity Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/California/07/2009 (H1N1); Pre-dose | 95.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/California/07/2009 (H1N1); Post-dose | 100.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/Texas/50/2012 (H3N2); Pre-dose | 97.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | A/Texas/50/2012 (H3N2); Post-dose | 99.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Massachusetts/2/2012; Pre-dose | 94.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Massachusetts/2/2012; Post-dose | 100.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Brisbane/60/2008; Pre-dose | 85.0 Percentage of participants |
| Quadrivalent Influenza Vaccine | Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine | B/Brisbane/60/2008; Post-dose | 100.0 Percentage of participants |