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The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflexal V 0.25 mL x 2 | Active Comparator |
| |
| Inflexal V 0.5 mL x 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflexal V | Biological | vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | Seroprotection rate | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen |
| Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | Seroconversion rate | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen |
| Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability | Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Principi, Prof Dr | Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122, Milano, Italy | Principal Investigator |
| Gian Vincenzo Zuccotti, Prof Dr | Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital, 74, Via GB Grassi, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital | Milan | 20157 | Italy | |||
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Recruitment period: 05 October - 17 January 2011; Location: University of Milan
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| ID | Title | Description |
|---|---|---|
| FG000 | Inflexal V 0.25 mL x 2 | 2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:
|
| FG001 | Inflexal V 0.5 mL x 1 | 1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inflexal V 0.25 mL x 2 | Two 0.25 mL doses (on Day 1 and 29) |
| BG001 | Inflexal V 0.5 mL x 1 | One 0.5 mL dose (on Day 1) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | Seroprotection rate | Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | percentage subjects | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen |
|
Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inflexal V 0.25 mL x 2 - After 1st Vaccination |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319806111 | info@crucell.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C475022 | Inflexal V |
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| Inflexal V | Biological | Inflexal V 0.5 mL administrated once only |
|
| Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena" |
| Milan |
| 20122 |
| Italy |
| Migrated/moved from study area |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability | Safety population, all vaccinated subjects | Posted | Number | participants | Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary |
|
|
|
| Primary | Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | Seroconversion rate | Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | percentage subjects | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen |
|
|
|
| Primary | Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value | Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | Fold (ratio) | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen |
|
|
|
| 1 |
| 102 |
| 51 |
| 102 |
| EG001 | Inflexal V 0.25 mL x 2 - After 2nd Vaccination | 0 | 101 | 48 | 101 |
| EG002 | Inflexal V 0.5 mL x 1 | 5 | 100 | 49 | 100 |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchopulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastroenterisits rotavirus | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Erythema (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Induration (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhage (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 60 days from the time submitted to the sponsor for review. The sponsor reserves the right to remove any proprietary or confidential information and to require that publication be delayed for up to 60 additional days to enable the sponsor to prepare and file patent applications.
| D012140 | Respiratory Tract Diseases |
|
| Solicited local AEs |
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| Solicited systemic AEs |
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| Percentage of subjects seroconverted: B-strain |
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| GMT fold increase from baseline: B-strain |
|