Phase 2
N=473
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00958243 ↗Enrolled (actual)
473
Serious AEs
1.1%
Results posted
Aug 2011
Primary outcome: Primary: Seroconversion Rate 21 Days After First Study Vaccination — 4.0; 88.2; 83.1; 3.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CSL's 2009 H1N1 Influenza Vaccine (CSL425) (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate 21 Days After First Study Vaccination |
4.0; 88.2; 83.1; 3.7; 84.6; 88.2 | — |
| PRIMARY Seroconversion Rate 21 Days After Second Study Vaccination |
28.6; 98.9; 100.0; 15.4; 98.0; 99.0 | — |
| PRIMARY Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination |
8.0; 90.2; 84.3; 25.9; 84.6; 89.2 | — |
| PRIMARY Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination |
28.6; 98.9; 100.0; 34.6; 98.0; 100.0 | — |
| SECONDARY Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A |
42; 44; 37; 35; 33; 27 | — |
| SECONDARY Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A |
1.00; 1.52; 1.91; 1.50; 2.20; 2.56 | — |
| SECONDARY Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B |
43; 38; 49; 29; 34; 40 | — |
| SECONDARY Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B |
1.33; 1.63; 1.46; 2.29; 2.17; 2.24 | — |
| SECONDARY Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination |
69; 52; 55; 50; 49; 41 | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) |
0; 2; 3; 0; 0; 0 | — |
Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
Eligibility Criteria
Inclusion Criteria
- Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
- For children < 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.
Exclusion Criteria
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
Data sourced from ClinicalTrials.gov (NCT00958243). 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.