Phase 3
Completed N=1,474
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Source: ClinicalTrials.gov NCT00959049 ↗Enrolled (actual)
1,474
Serious AEs
0.9%
Results posted
Jul 2011
Primary outcomePrimary: Geometric Mean Titer 30 Days After the Last Study Vaccination — 235.44; 345.50; 652.99; 227.19 Titers
Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer 30 Days After the Last Study Vaccination |
235.44; 345.50; 652.99; 227.19; 351.88; 652.17 | — |
| PRIMARY Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination |
84; 66; 64; 74; 64; 61 | — |
| SECONDARY Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) |
116; 100; 98; 78; 1; 0 | — |
| SECONDARY Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B |
164; 152; 149; 131; 1; 4 | — |
| SECONDARY Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C |
174; 169; 167; 151; 1; 4 | — |
| SECONDARY Frequency and Intensity of Unsolicited Adverse Events (UAEs) |
123; 100; 88; 112; 84; 70 | — |
| SECONDARY New Onset of Chronic Illnesses (NOCIs) |
2; 0; 2; 2; 1; 0 | — |
| SECONDARY Serious Adverse Events (SAEs) |
4; 2; 2; 4; 0; 0 | — |
| SECONDARY Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) |
1.57; 1.43; 2.09; 2.22; 3.13; 2.00 | — |
| SECONDARY Duration of Local and Systemic Solicited Symptoms, Cohort B |
1.89; 1.89; 2.32; 2.10; 2.39; 2.09 | — |
| SECONDARY Duration of Local and Systemic Solicited Symptoms, Cohort C |
1.96; 1.99; 2.02; 2.38; 1.75; 2.38 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
- For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
- Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.
Exclusion Criteria
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Data sourced from ClinicalTrials.gov (NCT00959049). 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.