CompletedPhase 1/2

Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

United States980 participantsStarted 2024-11-18

Plain-language summary

Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number of injections and to maintain observer blinding. Thus, each participant will receive two injections at enrollment, one in each deltoid muscle. Study details include: * The study duration will be approximately 12 months * Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on Day(D) 01 * Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose) * The visit frequency for participants will be D01 and D30, and D09-D366 (telephone call) Number of Participants: Approximately 980 participants are expected to be randomized.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria to be checked at Screening Visit: * Aged 50 years or older on the day of inclusion Informed consent * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all study procedures. * Participant must be able to receive an injection in the deltoid muscle of both arms. * Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine. Inclusion criteria to be checked at Visit 1 (Day \[D\]01): * Aged 50 years or older on the day of inclusions * Participants who are healthy or with pre-existing stable condition (defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before enrollment), as determined by medical evaluation including medical history and physical examination. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. OR • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration. A female participant of childbearing …

What they're measuring

Number of participants with immediate adverse events (AEs)

Timeframe: Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination

Number of participants with solicited injection site reactions

Timeframe: Up to 7 each days after vaccination

Number of participants with solicited systemic reactions

Timeframe: Up to 7 days after each vaccination

Number of participants with unsolicited AEs

Timeframe: Up to 28 days after each vaccination

Number of participants with adverse events of special interest (AESIs)

Timeframe: Up to 180 days after each vaccination

Number of participants with medical attended adverse events (MAAEs)

Timeframe: Up to 180 days after each vaccination

Number of participants with MAAEs relating to predefined PIMDs

Timeframe: From Day 182 through 12 months following the last study vaccination

Trial details

NCT IDNCT06695130

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-03

View on ClinicalTrials.gov More COVID-19 Immunization trials

Plain-language summary

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with immediate adverse events (AEs)

Timeframe: Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination

Number of participants with solicited injection site reactions

Timeframe: Up to 7 each days after vaccination

Number of participants with solicited systemic reactions

Timeframe: Up to 7 days after each vaccination

Number of participants with unsolicited AEs

Timeframe: Up to 28 days after each vaccination

Number of participants with adverse events of special interest (AESIs)

Timeframe: Up to 180 days after each vaccination

Number of participants with medical attended adverse events (MAAEs)

Timeframe: Up to 180 days after each vaccination

Number of participants with MAAEs relating to predefined PIMDs

Timeframe: From Day 182 through 12 months following the last study vaccination