Phase 2
N=1,313
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00958126 ↗Enrolled (actual)
1,313
Serious AEs
3.1%
Results posted
Oct 2012
Primary outcome: Primary: Seroconversion Rate 21 Days After the First Vaccination — 0; 82; 88.2; 94.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CSL425 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate 21 Days After the First Vaccination |
0; 82; 88.2; 94.5; 2.1; 51.2 | — |
| PRIMARY Seroconversion Rate 21 Days After the Second Vaccination |
6.3; 83.2; 91.1; 95.9; 8.3; 59.5 | — |
| PRIMARY Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination |
22.9; 97.0; 96.4; 99.5; 39.6; 92.0 | — |
| PRIMARY Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination |
29.2; 98.5; 99.5; 99.5; 35.4; 96.0 | — |
| SECONDARY Frequency and Intensity of Solicited Adverse Events After the First Vaccination |
22.4; 28.9; 35.8; 52.7; 4.0; 13.3 | — |
| SECONDARY Duration of Solicited Local Adverse Events After the First Vaccination |
1.14; 1.87; 1.71; 1.91; 1.00; 1.75 | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) |
0; 2.9; 2.0; 1.5; 6.0; 4.4 | — |
| SECONDARY Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination |
27.3; 27.5; 30.2; 27.9; 7.1; 12.8 | — |
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 adults
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 and older, inclusive, at the time of providing informed consent.
- Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.
Exclusion Criteria
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
Data sourced from ClinicalTrials.gov (NCT00958126). 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.