Phase 3
Completed N=1,356
Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children
Source: ClinicalTrials.gov NCT01310400 ↗Enrolled (actual)
1,356
Serious AEs
0.2%
Results posted
May 2013
Primary outcomePrimary: Immunogenicity, Assessed by the Haemagglutination (HI) Test — 97.2; 89.7; 92.7; 90.5 percentage of participants — p=0.0036
Summary
A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity, Assessed by the Haemagglutination (HI) Test |
97.2; 89.7; 92.7; 90.5; 83.4; 82.6 | 0.0036 sig |
| SECONDARY Fold Increase in Geometric Mean Titer (GMT) |
36.6; 25.9; 25.4; 72.5; 48.8; 54.2 | — |
| SECONDARY Seroprotection |
97.6; 92.1; 93.2; 91.3; 84.5; 82.8 | — |
| SECONDARY Safety: Incidence of Solicited and Unsolicited Adverse Events |
38.5; 33.0; 35.7; 32.3; 29.1; 29.5 | — |
Eligibility Criteria
Inclusion Criteria
- ≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
- Recording of medical history and physical examination reveal no abnormality
- The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization
Exclusion criteria
- Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
- Previous vaccination against influenza
- At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
- Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
- Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)
- Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study
- Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period
- At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs
- Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided)
- Family history of Guillain-Barré Syndrome
- Severe congenital deficiency or disease
- Antecedent of neurological disease or epileptic attack
- Severe cardiopulmonary disease with possibility to influence the study result
- Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection
- Suspected non-compliance
Data sourced from ClinicalTrials.gov (NCT01310400). 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. Informational only — not medical advice.