免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Efficacy Study With QIVc in Pediatric Subjects
Efficacy Study With QIVc in Pediatric Subjects
Study Description
Brief Summary:
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza, Human | Biological: QIVc Biological: Comparator | Phase 3 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3830 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The trial is designed as an observer-blind study. During the treatment period of the study designated and trained unblinded personnel will be responsible for administering the study vaccines to the subjects. |
| Primary Purpose: | Prevention |
| Official Title: | A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months |
| Actual Study Start Date : | May 13, 2019 |
| Estimated Primary Completion Date : | September 27, 2023 |
| Estimated Study Completion Date : | September 27, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Seqirus QIVc
Cell-derived Quadrivalent Influenza Vaccine
|
Biological: QIVc
QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
Other Name: Flucelvax Quadrivalent
|
|
Active Comparator: Comparator
Non-influenza Comparator (NesiVac-C)
|
Biological: Comparator
Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)
|
Outcome Measures
Primary Outcome Measures :
- Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match [ Time Frame: Day 14 to Day 180 ]First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
- Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Secondary Outcome Measures :
- Efficacy Endpoint: First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
- Efficacy Endpoint: First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
- Efficacy Endpoint: First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season
- Immunogenicity Endpoint: a) Prevaccination and postvaccination Geometric Mean Titer (GMT) [ Time Frame: Day 1 and 28 days after last vaccination ]The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a microneutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
- Immunogenicity Endpoint: Seroconversion rates (SCR) [ Time Frame: Day 1 and 28 days after last vaccination ]
The measures for immunogenicity are determined by a HI and/or a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
SCR is defined as the percentage of subjects with either a prevaccination HI (or MN) titer < 1:10 and a postvaccination HI (or MN) titer ≥ 1:40, or a prevaccination HI (or MN) titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI (or MN) titer
- Immunogenicity endpoint: Geometric Mean Ratio (GMR) [ Time Frame: Day 1 and 28 days after last vaccination ]
The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a micro neutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
GMR is the geometric mean of the fold increase of post-vaccination HI (or MN) titer over the pre-vaccination HI (or MN) titer
- Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events (AE) [ Time Frame: 7 days following each vaccination ]Percentage of subjects with solicited local and systemic AEs will be assessed for 7 days following each vaccination in the QIVc group and in the comparator group
- Safety Endpoint: Percentage of subjects with unsolicited AEs [ Time Frame: 28 days following each vaccination ]Percentage of subjects with any unsolicited AEs will be assessed in the QIVc group and in the comparator group until 28 days after each vaccination
- Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AEs leading to withdrawal from the study or vaccination [ Time Frame: Day 1 to Day 180 ]Percentage of subjects with serious AEs (SAE), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events will be reported in the QIVc group and in the comparator group
- Safety Endpoint: Percentage of subjects with medically-attended AEs [ Time Frame: 30 days following ILI onset ]Percentage of subjects with medically-attended AEs within 30 days after ILI onset will be reported in the QIVc group and in the comparator group
Eligibility Criteria
| Ages Eligible for Study: | 6 Months to 47 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
In order to participate in this study, all subjects must meet all of the inclusion criteria described.
- Individuals of 6 through 47 months of age on the day of informed consent.
- Individuals whose parent(s)/Legally Acceptable Representative(LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up .
- Individuals in generally good health as per the Investigator's medical judgement.
Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.
Exclusion Criteria:
- Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
- History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
- A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
- Abnormal function of the immune system resulting from a clinical condition
- Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
- Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.
Additional eligibility criteria may be discussed by contacting the site.
Contacts and Locations
Contacts
| Contact: Seqirus Clinical Data Disclosure Manager | (855) 358-8966 | seqirus.clinicaltrials@seqirus.com |
Locations
Show 56 study locations
Sponsors and Collaborators
Seqirus
Investigators
| Study Director: | Clinical Program Director | Seqirus |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 22, 2019 | ||||||
| First Posted Date ICMJE | May 1, 2019 | ||||||
| Last Update Posted Date | March 11, 2021 | ||||||
| Actual Study Start Date ICMJE | May 13, 2019 | ||||||
| Estimated Primary Completion Date | September 27, 2023 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Efficacy Study With QIVc in Pediatric Subjects | ||||||
| Official Title ICMJE | A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months | ||||||
| Brief Summary | This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: The trial is designed as an observer-blind study. During the treatment period of the study designated and trained unblinded personnel will be responsible for administering the study vaccines to the subjects. Primary Purpose: Prevention
|
||||||
| Condition ICMJE | Influenza, Human | ||||||
| Intervention ICMJE |
|
||||||
| Study Arms ICMJE |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
3830 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | September 27, 2023 | ||||||
| Estimated Primary Completion Date | September 27, 2023 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: In order to participate in this study, all subjects must meet all of the inclusion criteria described.
Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations. Exclusion Criteria:
Additional eligibility criteria may be discussed by contacting the site. |
||||||
| Sex/Gender ICMJE |
|
||||||
| Ages ICMJE | 6 Months to 47 Months (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE |
|
||||||
| Listed Location Countries ICMJE | Bangladesh, Bulgaria, Czechia, Estonia, Honduras, Latvia, Malaysia, New Zealand, Philippines, Poland, Romania, Thailand, Ukraine | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03932682 | ||||||
| Other Study ID Numbers ICMJE | V130_14 2018-001857-29 ( EudraCT Number ) |
||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement ICMJE |
|
||||||
| Responsible Party | Seqirus | ||||||
| Study Sponsor ICMJE | Seqirus | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
|
||||||
| PRS Account | Seqirus | ||||||
| Verification Date | March 2021 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||
