临床试验/NCT05886777

NCT05886777已完成2 期

A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATE(S) AGAINST INFECTIOUS RESPIRATORY ILLNESSES, INCLUDING COVID-19 AND RSV, IN HEALTHY INDIVIDUALS

Pfizer34 个研究点分布在 1 个国家目标入组 1,142 人开始时间: 2023年6月5日最近更新: 2024年12月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Pfizer
入组人数: 1,142
试验地点: 34
主要终点: Percentage of Participants With Local Reactions Within 7 Days After Vaccination

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to learn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections.

This study is seeking participants who:

are 65 years of age or older.
are healthy or have well-controlled chronic conditions.
in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1).
have not had a flu shot in the last 120 days.
agree to be present for all study visits, procedures, and blood draws.

Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 65 Years 至 —（Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female participants ≥65 years of age at Visit 1 (Day 1).
•Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
•Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
•Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
•Participants who have received at least 3 prior US authorized mRNA COVID 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before Visit A101 (Day 1).

排除标准

•A confirmed diagnosis of COVID 19, RSV infection, or influenza ≤120 days before study intervention administration.
•History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
•Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
•Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
•Allergy to egg proteins (egg or egg products) or chicken proteins.
•Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
•Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
•Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
•Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
•Receipt of any influenza vaccine ≤120 days before study enrollment.
•Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
•Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

研究组 & 干预措施

Group 7

Experimental

Coadministration RSVpreF + bivalent BNT162b2 + QIV

干预措施: Bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)

Group 1

Experimental

Combination [RSVpreF+BNT162b2] + Quadrivalent influenza vaccine (QIV)

干预措施: Combination [RSVpreF+BNTb162b2] (Biological)

Group 1

Experimental

Combination [RSVpreF+BNT162b2] + Quadrivalent influenza vaccine (QIV)

干预措施: QIV (Biological)

Group 2

Experimental

Combination [RSVpreF+BNT162b2] + placebo

干预措施: Combination [RSVpreF+BNTb162b2] (Biological)

Group 2

Experimental

Combination [RSVpreF+BNT162b2] + placebo

干预措施: Normal Saline Placebo (Biological)

Group 3

Active Comparator

BNT162b2 + placebo

干预措施: Bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)

Group 3

Active Comparator

BNT162b2 + placebo

干预措施: Normal Saline Placebo (Biological)

Group 4

Active Comparator

RSVpreF + placebo

干预措施: RSVpreF (Biological)

Group 4

Active Comparator

RSVpreF + placebo

干预措施: Normal Saline Placebo (Biological)

Group 5

Active Comparator

QIV + placebo

干预措施: QIV (Biological)

Group 5

Active Comparator

QIV + placebo

干预措施: Normal Saline Placebo (Biological)

Group 6

Experimental

Coadministration RSVpreF + bivalent BNT162b2 + placebo

干预措施: Bivalent BNT162b2 (original/Omi BA.4/BA.5) (Biological)

Group 6

Experimental

Coadministration RSVpreF + bivalent BNT162b2 + placebo

干预措施: RSVpreF (Biological)

Group 6

Experimental

Coadministration RSVpreF + bivalent BNT162b2 + placebo

干预措施: Normal Saline Placebo (Biological)

Group 7

Experimental

Coadministration RSVpreF + bivalent BNT162b2 + QIV

干预措施: RSVpreF (Biological)

Group 7

Experimental

Coadministration RSVpreF + bivalent BNT162b2 + QIV

干预措施: QIV (Biological)

结局指标

主要结局

Percentage of Participants With Local Reactions Within 7 Days After Vaccination

时间窗: Day 1 to Day 7 after Vaccination on Day 1

Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.

Percentage of Participants With Systemic Events Within 7 Days After Vaccination

时间窗: Day 1 to Day 7 after Vaccination on Day 1

Systemic events included fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain and joint pain. These were recorded by participants in an e-diary. Fever was defined as oral temperature greater than or equal to (\>=) 38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C and severe: \>38.9 to 40.0 deg C. Vomiting was categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea was categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity and severe: prevented daily routine activity.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

时间窗: Within 1 Month after Vaccination

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure.

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination

时间窗: Within 6 Months after Vaccination

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.

Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4