Phase 3
N=959
A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Bottom Line
View on ClinicalTrials.gov: NCT06134804 ↗Enrolled (actual)
959
Serious AEs
1.3%
Results posted
Apr 2026
Primary outcome: Primary: 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 — 368.94; 362.43; 328.38; 335.91 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ExPEC9V (Biological); Placebo (Biological); HD quadrivalent influenza vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
368.94; 362.43; 328.38; 335.91; 727.27; 703.30 | — |
| PRIMARY Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V |
5346351.53; 7269565.30; 2452599.76; 3865399.96; 5584467.27; 7110481.05 | — |
| SECONDARY 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 |
76.1; 74.4; 79.9; 73.1; 71.7; 65.6 | — |
| SECONDARY 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 |
93.1; 93.4; 88.6; 89.6; 98.0; 99.6 | — |
| SECONDARY Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination |
64.9; 54.3; 11.9; 35.2 | — |
| SECONDARY Percentage of Participants With Solicited Systemic AEs for 14 Days After Each Vaccination |
53.8; 44.9; 26.0; 36.9 | — |
| SECONDARY Percentage of Participants With Unsolicited AEs for 29 Days After Each Vaccination |
15.3; 17.7; 13.4; 15.0 | — |
| SECONDARY Percentage of Participants With Medically-attended Adverse Events (MAAEs) From Vaccination 1 Until 6 Months After Vaccination 2 |
17.2; 17.7 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 Until 6 Months After Vaccination 2 |
2.7; 2.3 | — |
| SECONDARY Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay |
739070.3; 5317596.0; 670938.4; 5075672.7; 7240450.4; 154948.9 | — |
| SECONDARY CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA) |
1630.0; 2245.4; 394.8; 1078.1; 1262.7; 1079.1 | — |
| SECONDARY Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA) |
2149.3; 3459.4; 482.9; 1223.2; 1712.4; 1744.7 | — |
| SECONDARY 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 |
6160478.9; 5071887.4; 2997612.3; 2148504.9; 6432286.8; 4733052.6 | — |
| SECONDARY 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 |
8651535.9; 6805961.9; 4943585.5; 3328481.3; 6839103.3; 6413949.7 | — |
| SECONDARY 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) |
1960.7; 1535.9; 2609.3; 2139.6; 455.3; 377.1 | — |
| SECONDARY 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) |
2286.3; 2103.6; 3910.8; 3314.6; 450.4; 494.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06134804). 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.