Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
Sponsor:
Sanofi Pasteur, a Sanofi Company
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | October 4, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | September 18, 2018 | ||
| Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Number of participants reporting solicited injection site reactions or systemic reactions[ Time Frame: Within 7 days after any injection ] Injection site reactions: tenderness/pain, erythema, swelling, induration and bruising. Systemic reactions for participants < 36 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; 3 to 17 years: fever, headache, malaise, myalgia, and shivering Geometric mean titers (GMTs) of influenza vaccine antibodies[ Time Frame: Day 28 after each injection ] Antibody titers are measured by HAI and expressed as GMTs Influenza vaccine antibody titer ratio[ Time Frame: Day 28 after each injection ] Ratio of titers measured by HAI on Day 28/Day 0 for all participants and Day 56/Day 0 for participants receiving 2 injections Number of participants with seroconversion[ Time Frame: Day 28 after each injection ] Antibody titers are measured by HAI. Seroconversion is defined as titer < 10 [1/dilution {dil}] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28 Number of participants with titers ≥ 40 (1/dil)[ Time Frame: Day 28 after each injection ] Antibody titers are measured by HAI Neutralization test (NT) titers of influenza vaccine antibodies[ Time Frame: Day 28 after each injection ] Antibody titers are measured by virus SN method and expressed as NT titers Influenza vaccine antibody NT titer ratio[ Time Frame: Day 28 after each injection ] Ratio of titers measured by virus SN method on Day 28/Day 0 for all participants and Day 56/Day 0 for participants receiving 2 injections Participants with influenza vaccine antibody NT titers above pre-defined thresholds[ Time Frame: Day 28 after each injection ] Antibody titers are measured by virus SN method Fold-increase in influenza vaccine antibody NT titer[ Time Frame: Day 28 after each injection ] Antibody titers are measured by virus SN method. The increase post/pre-injection ≥2 and ≥ 4 is assessed |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age |
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| Official Title ICMJE | Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age |
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| Brief Summary | The objectives of this study are: - To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study - To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) - To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement methods - To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods |
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| Detailed Description | Study duration per participant will be approximately 180 days for participants receiving one dose of vaccine and 208 days for participants receiving two doses of vaccine | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: The study will be divided into 13 groups and will enroll in 4 stages. The study will use a stepwise age de-escalation and dose ascension design for children 6 months to < 5 years of age. Masking: Interventional Masking Description:Modified double-blind: the participant's parent / legally acceptable representative, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccine but will not be involved in safety data collection. Primary Purpose: Prevention |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
700 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | August 2019 | ||
| Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion criteria : - Aged 6 months to 17 years on the day of inclusion - Assent form has been signed and dated by the subject (7 to 17 years of age) and informed consent form has been signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations - Subject / and subject and parent / guardian are able to attend all scheduled visits and to comply with all study procedures - For subjects aged < 24 months: Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg Exclusion criteria: - Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 3 for subjects receiving 1 dose of influenza vaccine or Visit 5 for subjects receiving 2 doses of influenza vaccine - For previously influenza vaccinated subjects: Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another vaccine - For previously influenza unvaccinated subjects: Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another influenza vaccine - For previously influenza unvaccinated subjects: Any previous laboratory confirmed influenza infection (from birth to the day of inclusion) - 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 systemic hypersensitivity 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 - Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement - 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 study 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 [≥ 100.4 F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided - Identified as an immediate family member (ie, spouse, natural or adopted child, grandchild, nephew, or niece) of the Investigator or employee with direct involvement in the proposed study - Personal history of GBS - 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 - Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder - Known seropositivity for hepatitis B or hepatitis C The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | ||
| Sex/Gender |
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| Ages | 6 Months and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Sanofi Pasteur, a Sanofi Company | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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