Phase 3
N=861
A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
COVID-19 Prevention
Bottom Line
View on ClinicalTrials.gov: NCT05091307 ↗Enrolled (actual)
861
Serious AEs
2.2%
Results posted
Aug 2023
Primary outcome: Primary: Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine — 306; 393; 134; 165 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ad26.COV2.S (Biological); Placebo (Other); Influenza Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine |
306; 393; 134; 165; 38; 38 | — |
| PRIMARY Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine |
22531; 25035 | — |
| SECONDARY Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination |
261; 204; 23; 21; 34; 210 | — |
| SECONDARY Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination |
256; 205; 30; 26; 84; 208 | — |
| SECONDARY Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination |
71; 71; 10; 9; 36; 50 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
9; 7; 1; 2 | — |
| SECONDARY Number of Participants With Medically-attended Adverse Events (MAAEs) |
51; 51; 11; 16 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) |
9; 12; 0; 0 | — |
| SECONDARY Number of Participants With AEs Leading to Withdrawal From the Study |
0; 0; 0; 0 | — |
| SECONDARY Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine |
286; 484; 284; 509; 61; 75 | — |
| SECONDARY Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine |
17569; 20743 | — |
| SECONDARY GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants |
10340; 14704; 38905 | — |
| SECONDARY Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine |
64.1; 70.0; 65.1; 70.7; 39.1; 46.8 | — |
| SECONDARY Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine |
97.8; 97.3; 100.0; 100.0; 92.8; 93.4 | — |
Summary
The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.
Eligibility Criteria
Inclusion Criteria
- Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participants may have underlying illnesses, as long as the symptoms and signs are medically controlled
- Participant either received complete primary vaccination with an authorized/licensed coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to [>=] 6 months prior to the last vaccination received against COVID-19) or is COVID-19 vaccine-naive
- All participants who were born female and are of childbearing potential must: a. Have a negative highly sensitive urine pregnancy test at screening, b. Have a negative highly sensitive urine pregnancy test on the day of vaccination prior to each study vaccine administration
- Participant agrees to not donate or receive bone marrow, blood, and blood products from the administration of the study vaccine until 3 months after receiving the study vaccines
- Participant must be willing to provide verifiable identification to be contacted and to contact the investigator during the study
Exclusion Criteria
- Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancies considered cured with minimal risk of recurrence per investigator's clinical judgment)
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit [°F]) within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
- Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
- Participant has history of capillary leak syndrome
- Participant received a licensed/registered severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study vaccination (other than study vaccination)
- Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
Data sourced from ClinicalTrials.gov (NCT05091307). 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.