Phase 2
N=369
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Influenza Caused by the Novel Influenza A (H1N1) Virus
Bottom Line
View on ClinicalTrials.gov: NCT00940108 ↗Enrolled (actual)
369
Serious AEs
1.9%
Results posted
Nov 2013
Primary outcome: Primary: Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination — 88.2; 97.3; 85.7; 91.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CSL425 (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination |
88.2; 97.3; 85.7; 91.9 | — |
| PRIMARY HI Antibody Titre Seroconversion Rate After the Second Vaccination |
96.9; 98.6; 97.9; 96.9 | — |
| PRIMARY Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination |
13.95; 22.17; 13.25; 15.93 | — |
| PRIMARY GMFI in the HI Antibody Titre After the Second Vaccination |
57.64; 72.93; 37.48; 37.06 | — |
| PRIMARY Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination |
92.1; 100.0; 92.9; 96.0 | — |
| PRIMARY Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination |
69.5; 63.8; 68.0; 71.2; 48.8; 43.8 | — |
| SECONDARY Duration of Solicited AEs After the First Vaccination |
1.48; 1.52; 1.91; 1.80; 2.08; 2.23 | — |
| SECONDARY Duration of Solicited AEs After the Second Vaccination |
1.67; 1.64; 1.90; 1.80; 1.69; 2.14 | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) |
4.9; 1.3; 1.0; 1.0; 0; 0 | — |
| SECONDARY Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination |
78.0; 82.5; 67.0; 76.0; 26.8; 33.8 | — |
Summary
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
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 of gestation.
Exclusion Criteria
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
Data sourced from ClinicalTrials.gov (NCT00940108). 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.