Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Conditions
Brief summary
The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.
Interventions
BIOLOGICALExPEC9V
ExPEC9V will be administered as an IM injection.
BIOLOGICALPlacebo
Placebo will be administered as an IM injection.
BIOLOGICALHD quadrivalent influenza vaccine
HD quadrivalent influenza vaccine will be administered as IM injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination * Participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods * Must sign an ICF indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study * Willing and able to adhere to the lifestyle restrictions specified in this protocol * Agrees to not donate blood from the time of vaccination until 3 months after receiving the last dose of study vaccine
Exclusion criteria
* History of an underlying clinically significant acute or uncontrolled chronic medical condition or significant cognitive impairment or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Known or suspected allergy or history of severe allergic reaction, anaphylaxis, or other serious adverse reactions to vaccines or vaccine excipients * History of severe allergic reactions (for example anaphylaxis) to any component of the high-dose (HD) quadrivalent seasonal influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine * Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the first study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination * History of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine | 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30) | HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported. |
| Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V | CoAd Group: 29 days after the administration of ExPEC9V on Day 1 (Day 30); Control Group: 29 days after the administration of ExPEC9V on Day 30 (Day 59) | Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by ECL based Immunoassay 29 days after administration of ExPEC9V on Day 1 in CoAd group and on Day 30 in Control group were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine | 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30) | Seroconversion was defined for each of the 4 influenza vaccine strains as 1) HI titer greater than or equal to (\>=) 1:40 in participants with a pre-vaccination HI titer of less than (\<) 1:10, or 2) a \>=4-fold HI titer increase in participants with a pre-vaccination HI titer of \>=1:10. |
| Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine | 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30) | Seroprotection was defined for each of the 4 influenza vaccine strains as HI titer \>=1:40 at 29 days after the administration of a HD quadrivalent seasonal influenza vaccine. |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination | Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44) | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) events for which participants were to be specifically questioned and which were noted by participants in their participant diary for 14 days post vaccination (day of vaccination and the subsequent 14 days). Solicited local AEs were injection site pain or tenderness, erythema and swelling at the study vaccine injection site. |
| Percentage of Participants With Solicited Systemic AEs for 14 Days After Each Vaccination | Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44) | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine and were pre-defined systemic events for which participants were to be specifically questioned and which were noted by participants in their participant diary for 14 days post vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs included fever (body temperature \>=100.4 degree Fahrenheit), fatigue, headache, nausea, myalgia, and fever. |
| Percentage of Participants With Unsolicited AEs for 29 Days After Each Vaccination | Up to 29 days post-vaccination 1 on Day 1 (Day 1 up to Day 30) and up to 29 days post-vaccination 2 on Day 30 (Day 30 up to Day 59) | Percentage of participants with unsolicited AEs for 29 days after each vaccination was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary. |
| Percentage of Participants With Medically-attended Adverse Events (MAAEs) From Vaccination 1 Until 6 Months After Vaccination 2 | From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210) | MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. |
| Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 Until 6 Months After Vaccination 2 | From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210) | Percentage of participants with SAEs from vaccination 1 to until 6 months after vaccination 2 was reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay | CoAd Group: Day 1 (Day of ExPEC9V vaccination), Day 30 (29 days after ExPEC9V vaccination), Day 59 (58 days after ExPEC9V vaccination); Control Group: Day 30 (Day of ExPEC9V vaccination), Day 59 (29 days after ExPEC9V vaccination) | Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) and EPA as determined by multiplex ECL-based immunoassay were reported. |
| CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA) | 29 days after the administration of ExPEC9V vaccine on Day 1 (Day 30) | Opsonophagocytic antibody titers to vaccine O-serotype antigens O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 as determined by MOPA were reported. |
| Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA) | 29 days after the administration of ExPEC9V vaccine on Day 30 (Day 59) | Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by MOPA were reported. |
| CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay | 29 days after the administration of ExPEC9V on Day 1 (Day 30) | Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported. |
| Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay | 29 days after the administration of ExPEC9V on Day 30 (Day 59) | Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported. |
| CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA) | 29 days after the administration of ExPEC9V on Day 1 (Day 30) | Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported. |
| Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA) | 29 days after the administration of ExPEC9V on Day 30 (Day 59) | Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported. |
Countries
Belgium, Canada, Poland, United States
Contacts
STUDY_DIRECTORJanssen Research & Development LLC Clinical Trial
Janssen Research & Development, LLC
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 5.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 451 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 22 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 868 Participants |
| Sex: Female, Male Female | 529 Participants |
| Sex: Female, Male Male | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 476 | 0 / 461 | 0 / 481 | 2 / 466 |
| other Total, other adverse events | 362 / 476 | 148 / 461 | 326 / 481 | 225 / 466 |
| serious Total, serious adverse events | 0 / 476 | 13 / 461 | 3 / 481 | 8 / 466 |
Outcome results
None listed