Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years
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ClinicalTrials.gov Identifier: NCT02550197 |
Recruitment Status :
Completed
First Posted : September 15, 2015
Results First Posted : November 4, 2016
Last Update Posted : March 28, 2022
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The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.
Objectives:
- To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.
- To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 Biological: Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 18 to 60 Years in the Republic of Korea |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
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Experimental: QIV Group
Subjects will receive one dose of the Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation
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Biological: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016
0.5 mL, Intramuscular |
Active Comparator: TIV Group
Subjects will receive one dose of the Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
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Biological: Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
0.5 mL, Intramuscular |
- Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ]Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
- Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ]Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
- Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ]Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
- Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 21 post-vaccination ]Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
- Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ]Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
- Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 0 up Day 3 post-vaccination ]The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
- Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route [ Time Frame: Day 0 up Day 7 post-vaccination ]Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged 18 to 60 years on the day of inclusion
- Subjects aged 18 years: Assent form has been signed and dated by the subject or by an independent witness, and informed consent form has been signed and dated by at least one parent or another legally acceptable representative or by an independent witness Subjects aged 19 to 60 years: Informed consent form has been signed and dated by the subject or by an independent witness
- Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination)
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine until the second visit, 3 weeks following the trial vaccination
- Vaccination against influenza if administered in the context of a clinical trial or a flu vaccination campaign or self-reported history of influenza infection (influenza-like illness) in the previous 6 months
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known history of seropositivity for Human Immunodeficiency Virus (HIV) or Hepatitis C
- Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
- Known or suspected thrombocytopenia, contraindicating intramuscular vaccination, based on Investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, based on Investigator's judgment
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550197
Korea, Republic of | |
Ansan-si, Korea, Republic of, 425-707 | |
Incheon, Korea, Republic of, 400-712 | |
Seoul, Korea, Republic of, 120-752 | |
Seoul, Korea, Republic of, 150-950 | |
Seoul, Korea, Republic of, 152-840 |
Study Director: | Medical Director | Sanofi Pasteur SA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT02550197 |
Other Study ID Numbers: |
GQM07 U1111-1143-9015 ( Other Identifier: WHO ) |
First Posted: | September 15, 2015 Key Record Dates |
Results First Posted: | November 4, 2016 |
Last Update Posted: | March 28, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
Influenza Quadrivalent influenza vaccine Trivalent influenza vaccine |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |