FluBub Study: Early influenza vaccination in infants
Safety and Immunogenicity of Early Quadrivalent Influenza Vaccine (FluBub Study)
Telethon Kids Institute
180 participants
Jul 2, 2020
Interventional
Conditions
Summary
Young children, particularly those younger than six (6) months are at increased risk of severe influenza infection. Influenza vaccination is recommended for all children 6 months of age or older, but not for younger children. This is despite their risk of severe disease. The safety and immune response to previously available trivalent influenza vaccines (TIV; conferring protection against three influenza strains) has already been demonstrated in infants under 6 months of age, yet these reassuring data have not translated into routine use. There are no data on the safety and immune response in infants under 6 months of age to quadrivalent influenza vaccines (QIV; conferring protection against four strains; routinely used in Australia since 2016), nor is anything known about the impact of the now recommended maternal influenza vaccination on vaccine responses in infants under 6 months of age. We will conduct a phase 2, prospective randomised open-label feasibility study to assess both the safety of early (under 6 months) influenza vaccination in healthy young infants and its ability to generate a protective immune response via antibody production (immunogenicity). This will be compared with infants vaccinated according to the currently recommended schedule. Approximately 160 infants will be randomised to a vaccination strategy which will either have an early start to the schedule or commence according to the currently recommended schedule. Arm 1: Early vaccination and booster (receipt of QIV at 6 to <12 weeks; booster at least 4 weeks later); Arm 3: [Control] Standard vaccination (QIV at 6-7 months of age; booster at least 4 weeks later); Solicited and unsolicited adverse events will be monitored. Antibody responses will be assessed using the standard haemagglutination inhibition and focal reduction assays. The strength of immune responses will be assessed across the different arms, and impact of amount of maternal antibody present will be considered in the analyses. Additional testing using a systems serological approach will be performed on remaining samples to generate new knowledge on the mechanisms determining vaccine efficacy. Surveillance for influenza infection will occur during the influenza season with episodes of acute respiratory infection confirmed through nasopharyngeal samples. This is a pilot study that will tell us whether a larger, more informative study will be worthwhile.
Eligibility
Inclusion Criteria3
- The mothers' year of birth was removed. to address obstacles to eligibility without compromising the study outcomes. This change occurred in Protocol v4.0 dated 21 April 2020.
- Infants will be enrolled in the study only if, in the opinion of the investigator, they and their mothers are considered able and likely to comply with the requirements of the research protocol.
- Arm 4, infants born to mothers with confirmed influenza infection was removed from Protocol v11 dated 17 October 2022 due to the low incidence of influenza cases and low recruitment numbers. Removal of this exploratory Arm will not compromise the study endpoints.
Exclusion Criteria8
- Infants born <37 weeks or >42 weeks gestation;
- Infants with congenital malformations, immunodeficiency or receiving immunosuppressive therapy
- Infants born to mothers with immunodeficiency or receiving immunosuppressive therapy;
- Infants previously receiving any monoclonal or polyclonal antibody (e.g, IV immunoglobulin);
- Infants currently enrolled in a clinical trial for a drug or vaccine.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results;
- infants whose parents/guardians are unwilling to comply with study requirements and follow-up until at least 8 months of age;
- Children of employees of the clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
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Interventions
Young children, particularly those younger than six (6) months are at increased risk of severe influenza infection. Influenza vaccination is recommended for all children 6 months of age or older, but not for younger children. This is despite their risk of severe disease. The safety and immune response to previously available trivalent influenza vaccines (TIV; conferring protection against three influenza strains) has already been demonstrated in infants under 6 months of age, yet these reassuring data have not translated into routine use. There are no data on the safety and immune response in infants under 6 months of age to quadrivalent influenza vaccines (QIV; conferring protection against four strains; routinely used in Australia since 2016), nor is anything known about the impact of the now recommended maternal influenza vaccination on vaccine responses in infants under 6 months of age. We will conduct a phase 2, prospective randomised open-label feasibility study to assess both the safety of early (under 6 months) influenza vaccination in healthy young infants and its ability to generate a protective immune response via antibody production (immunogenicity). This will be compared with infants vaccinated according to the currently recommended schedule. Approximately 160 infants will be randomised to a vaccination strategy which will either have an early start to the schedule or commence according to the currently recommended schedule. Arm 1: Early vaccination and booster (receipt of QIV at 6 to <12 weeks; booster at least 4 weeks later); Arm 3: [Control] Standard vaccination (QIV at 6-7 months of age; booster at least 4 weeks later); Solicited and unsolicited adverse events will be monitored. Antibody responses will be assessed using the standard haemagglutination inhibition and focal reduction assays. The strength of immune responses will be assessed across the different arms, and impact of amount of maternal antibody present will be considered in the analyses. Additional testing using a systems serological approach will be performed on remaining samples to generate new knowledge on the mechanisms determining vaccine efficacy. Surveillance for influenza infection will occur during the influenza season with episodes of acute respiratory infection confirmed through nasopharyngeal samples. This is a pilot study that will tell us whether a larger, more informative study will be worthwhile.
Locations(8)
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ACTRN12620000644965