Influenza Clinical Trial
Official title:
A Randomized, Partially Observer-blind, Single-centre Study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Influenza Vaccines in Adults Primed With Adjuvanted Influenza A/Vietnam/1194/04 (H5N1) Vaccine
This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.
OBJECTIVES:
Immunogenicity objectives
1. To evaluate the magnitude of the antibody responses to one or two 'priming' 0.5mL
intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1)
influenza vaccine, each dose containing 7.5μg of H5N1 haemagglutinin, in
immunologically naïve subjects;
2. To examine the kinetics of the antibody responses to one 0.5mL 'booster' intramuscular
dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically
drifted vaccine, given at doses of 3.75 or 7.5μg, in subjects primed with one or two
doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
3. To evaluate the magnitude of the antibody responses to one 0.5mL 'booster'
intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted
antigenically drifted vaccine, given at doses of 3.75μg or 7.5μg, in subjects primed
with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1)
influenza vaccine;
4. To evaluate the breadth of the antibody responses induced by 'priming' (see 1., above),
and 'booster' vaccination regimens (see 2., and 3., above), with respect to a
representative range of antigenically distinct H5N1 viruses (wild-type and attenuated);
and
5. To evaluate the persistence of the antibody responses induced by 'priming' (see 1.,
above), and 'booster' vaccination regimens (see 2., and 3., above).
Safety objective
1. To evaluate the safety of the administration of one or two 'priming' 0.5mL intramuscular
(IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (each
dose containing 7.5μg of H5N1 haemagglutinin), in immunologically naïve subjects, followed
by one 3.75μg or 7.5μg 'booster' dose of antigenically drifted MF59-adjuvanted H5N1 vaccine,
or non-adjuvanted antigenically drifted H5N1 vaccine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |