Phase 2
N=422
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
A/Vietnam/H5N1 Influenza Virus
Bottom Line
View on ClinicalTrials.gov: NCT02680002 ↗Enrolled (actual)
422
Serious AEs
1.7%
Results posted
Aug 2020
Primary outcome: Primary: Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. — 34; 41; 34; 34 occurrences
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 7.5 mcg H5N1 (stored as monobulk) (Biological); 15 mcg H5N1 (stored as monobulk) (Biological); 90 mcg H5N1 (stored as monobulk) (Biological); 90 mcg H5N1 (stored in vials) (Biological); MF59 (Other); MF59 (stored as monobulk) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biomedical Advanced Research and Development Authority
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. |
26; 24; 23; 24; 18; 23 | — |
| PRIMARY Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. |
26; 24; 23; 24; 18; 23 | — |
| PRIMARY Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. |
20; 20; 17; 21; 17; 21 | — |
| PRIMARY Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. |
20; 20; 17; 21; 17; 21 | — |
| PRIMARY Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. |
20; 17; 23; 24; 17; 18 | — |
| PRIMARY Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. |
11; 10; 11; 17; 9; 9 | — |
| PRIMARY Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody |
40.0; 40.0; 40.0; 56.6; 20; 14.1 | — |
| SECONDARY Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events (AE) |
28; 37; 36; 42; 31; 27 | — |
| SECONDARY Frequency of Unsolicited Adverse Events (AE) |
184; 179; 186; 202; 156; 174 | — |
| SECONDARY Occurrence of Clinical Safety Laboratory AEs |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies |
5.0; 5.0; 5.4; 5.2; 5.1; 5.3 | — |
| SECONDARY GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies |
6.1; 5.5; 5.5; 6.0; 5.4; 5.7 | — |
| SECONDARY Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies |
13; 6; 8; 18; 12; 16 | — |
| SECONDARY Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies |
10; 3; 11; 13; 9; 12 | — |
Summary
The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.
Eligibility Criteria
Inclusion Criteria
- Male or nonpregnant female
- Provide written informed consent prior to study-related procedures
- Stable health status
- Access to consistent and reliable means of telephone contact
- Able to understand and comply with planned study procedures
- Agree to stay in contact with site, and no plans to move from study area for study duration
Exclusion Criteria
- Allergic to eggs, other vaccine components, or squalene-based adjuvants
- Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
- Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
- Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
- Have an active neoplastic disease or history of hematologic malignancy
- Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose inhaled steroids (>800 mcg/day) within preceding 6 months
- Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
- Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years
Data sourced from ClinicalTrials.gov (NCT02680002). 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.