Phase 3 N=205 Randomized Prevention

Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT01229397 ↗

Enrolled (actual)

205

Serious AEs

2.0%

Results posted

May 2013

Primary outcome: 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 — 99.0; 98.0; 99.0; 97.0 percentage subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Inflexal V (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Crucell Holland BV
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
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	25.5; 19.6; 31.6; 24.6; 12.8; 14.7	—
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	25.5; 19.6; 31.6; 24.6; 12.8; 14.7	—
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	25.5; 19.6; 31.6; 24.6; 12.8; 14.7	—
SECONDARY Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability	51; 48; 49; 29; 32; 30	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01229397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.