Phase 2
N=240
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Influenza Caused by the Novel Influenza A (H1N1) Virus
Bottom Line
View on ClinicalTrials.gov: NCT00938639 ↗Enrolled (actual)
240
Serious AEs
0.4%
Results posted
Nov 2013
Primary outcome: Primary: Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination — 74.2; 81.5; 77.5; 75.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CSL425 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination |
74.2; 81.5; 77.5; 75.6 | — |
| PRIMARY HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination |
82.1; 89.6; 87.2; 83.5 | — |
| PRIMARY Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination |
11.83; 19.54; 24.83; 39.70 | — |
| PRIMARY GMFI in the HI and MN Antibody Titer After the Second Vaccination |
16.00; 23.30; 32.30; 46.50 | — |
| PRIMARY Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination |
95.0; 89.1; 88.3; 83.2 | — |
| PRIMARY Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination |
98.3; 96.5; 95.7; 92.2 | — |
| SECONDARY HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group |
77.6; 71.0; 85.2; 77.6; 82.8; 72.6 | — |
| SECONDARY HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group |
83.6; 80.6; 87.9; 91.2; 89.1; 85.5 | — |
| SECONDARY GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group |
15.13; 9.39; 25.79; 14.60; 36.73; 17.21 | — |
| SECONDARY GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group |
18.00; 14.41; 26.01; 20.82; 37.95; 28.00 | — |
| SECONDARY Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group |
96.6; 93.5; 98.4; 79.3; 94.8; 82.3 | — |
| SECONDARY Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group |
98.2; 98.4; 100.0; 93.0; 100.0; 91.9 | — |
| SECONDARY Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination |
92.9; 83.7; 95.2; 93.6; 77.4; 74.0 | — |
| SECONDARY Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination |
64.1; 80.0; 74.7; 86.8; 77.6; 78.3 | — |
| SECONDARY GMFI in the HI Antibody Titre 180 Days After the Second Vaccination |
0.49; 0.42 | — |
| SECONDARY Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination |
95.7; 91.9 | — |
| SECONDARY Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination |
40.0; 49.2; 20.8; 22.5; 0; 0 | — |
| SECONDARY Duration of Solicited Local AEs After the First Vaccination |
1.96; 1.67; 1.00; 1.00; 1.64; 2.70 | — |
| SECONDARY Frequency and Intensity of Solicited Local AEs After the Second Vaccination |
28.6; 42.9; 11.8; 16.8; 0; 0 | — |
| SECONDARY Duration of Solicited Local AEs After the Second Vaccination |
1.50; 2.40; 6.00; 1.67; 1.75; 1.43 | — |
| SECONDARY Frequency and Intensity of Solicited Systemic AEs After the First Vaccination |
37.5; 53.3; 26.7; 37.5; 0; 0 | — |
| SECONDARY Duration of Solicited Systemic AEs After the First Vaccination |
1.15; 1.64; 2.00; 1.47; 2.24; 1.67 | — |
| SECONDARY Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination |
19.3; 32.8; 12.6; 21.8; 0; 0 | — |
| SECONDARY Duration of Solicited Systemic AEs After the Second Vaccination |
1.19; 1.58; 1.64; 2.10; 2.08; 2.06 | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) |
0.8; 0; 0; 0; 0; 0 | — |
| SECONDARY Frequency and Intensity of Unsolicited AEs |
40.0; 35.0; 24.2; 15.8; 15.0; 15.0 | — |
Summary
The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.
Eligibility Criteria
Inclusion Criteria
- Male or female aged >= 18 to < 65 years at the time of providing informed consent.
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 (NCT00938639). 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.