Phase 4
N=1,992
Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00825162 ↗Enrolled (actual)
1,992
Serious AEs
1.3%
Results posted
Jul 2011
Primary outcome: Primary: Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) — 254; 167; 160; 111 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CSL Limited Influenza Virus Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) |
254; 167; 160; 111; 1; 2 | — |
| PRIMARY Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) |
1.83; 1.76; 2.55; 2.74; 3.06; 3.20 | — |
| PRIMARY Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) |
512; 312; 463; 282; 2; 2 | — |
| PRIMARY Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) |
1.89; 1.68; 2.45; 2.21; 2.48; 2.09 | — |
| PRIMARY Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) |
281; 271; 1; 66; 8; 52 | — |
| PRIMARY Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) |
2.02; 2.52; 2.81; 1.21; 1.97; 2.20 | — |
| SECONDARY Frequency and Intensity of Unsolicited Adverse Events (UAEs) |
531; 521; 167; 115; 183; 63 | — |
| SECONDARY Frequency of Serious Adverse Events |
19; 5; 2; 0; 0; 0 | — |
| SECONDARY Frequency of New Onsets of Chronic Illness |
10; 5; 2; 2; 0; 0 | — |
Summary
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
Eligibility Criteria
Inclusion Criteria
- Healthy male or female participants aged ≥ 6 months to 3 days in the 3 months preceding vaccination; ii. Age 9 years and above: ≥ 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination; Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study;
- Current treatment with warfarin or other anticoagulants;
- Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or entry into such a study during the on study period;
- Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
- If, in the Investigator's opinion, the participant should not take part in the clinical study.
Data sourced from ClinicalTrials.gov (NCT00825162). 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.