Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
This study has been completed.
Sponsor:
Crucell Holland BV
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01229397
First received: October 22, 2010
Last updated: July 18, 2012
Last verified: September 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Inflexal V |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule |
Resource links provided by NLM:
Further study details as provided by Crucell Holland BV:
Primary Outcome Measures:
- 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 ≤60 years) as reference [ Time Frame: This assesment will be done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with local and systemic adverse events as a measure of safety and tolerability [ Time Frame: This assesment will be done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ] [ Designated as safety issue: Yes ]
| Enrollment: | 205 |
| Study Start Date: | October 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Inflexal V 0,25mL x2 |
Biological: Inflexal V
vaccination with Inflexal V 0,25mL x 2
|
| Experimental: Inflexal V 0,5mL x 1 |
Biological: Inflexal V
Inflexal V 0,5mL administrated once only
|
Eligibility| Ages Eligible for Study: | 6 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female children
- Aged ≥6 to <36 months on Day 1
- Born at a gestational age ≥37 weeks
- Written informed consent
- No previous influenza vaccination
Exclusion Criteria:
- Acute respiratory infection or other acute disease
- Acute febrile illness (≥38.0 °C)
- Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus
- Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)
- Known hypersensitivity to any vaccine component
- Known history of egg protein allergy or severe atopy
- Known blood coagulation disorder
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed)
- Known immunodeficiency (including leukemia, cancer, HIV seropositivity)
- Investigational medicinal product received in the past 3 months (90 days)
- Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period
- Participation in another clinical trial
- Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee
- Suspected non-compliance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229397
Locations
| Italy | |
| Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital | |
| Milan, Italy, 20157 | |
| Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena" | |
| Milano, Italy, 20122 | |
Sponsors and Collaborators
Crucell Holland BV
Investigators
| Principal Investigator: | 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, |
More Information
No publications provided
| Responsible Party: | Crucell Holland BV |
| ClinicalTrials.gov Identifier: | NCT01229397 History of Changes |
| Other Study ID Numbers: | INF-V-A005 |
| Study First Received: | October 22, 2010 |
| Last Updated: | July 18, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Crucell Holland BV:
|
Influenza Virus Vaccination Immunisation |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013