Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

• Sponsor: Pfizer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05301322
• Collaborator: (none)
• Enrollment: 2,230
• Locations: 32
• Arms: 2
• Anticipated Duration (Months): 4.7
• Patients Per Site: 69.7
• Patients Per Site Per Month: 14.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus	Biological: RSVpreF Vaccine; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine	Phase 3

Detailed Description

This Phase 3, multicenter, parallel-group, placebo-controlled, randomized, double-blind study will be conducted in Australia and/or another southern hemisphere country.

Healthy adults ≥65 years of age will be randomized 1:1 to either the coadministration group (RSVpreF + SIIV)/placebo or the sequential-administration group (placebo + SIIV)/RSVpreF. This study design intends to use a single lot of NIP SIIV that is specifically indicated for use in adults ≥65 years of age.

There are 3 scheduled study visits each 1 month apart. To assess immunogenicity, 30 mL blood will be collected prior to vaccination at Visit 1 and Visit 2, and at Visit 3.

Local reactions (redness, swelling, and pain at the injection site) occurring at the RSVpreF or placebo injection site (left deltoid) and systemic events (fever, headache, fatigue, nausea, vomiting, diarrhea, muscle pain, and joint pain) occurring within 7 days after each vaccination visit (Visit 1 and Visit 2) will be prompted for and collected daily by the participant in an e-diary device or smartphone app. SIIV injection site reactions will not be routinely collected in the e-diary.

AEs and SAEs will be collected from the signing of informed consent through Visit 3.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: ParallelParallel
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This study is double-blinded. The participant, study coordinator, and all site staff will be blinded. The majority of sponsor staff will be blinded to study intervention allocation. All laboratory testing personnel performing serological assays or diagnostic assays will remain blinded to the study intervention assigned/received throughout the study.
• Primary Purpose: Prevention
• Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE IN ADULTS ≥65 YEARS OF AGE
• Actual Study Start Date: Apr 13, 2022
• Anticipated Primary Completion Date: Sep 2, 2022
• Anticipated Study Completion Date: Sep 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coadministration Group RSVpreF and SIIV followed by placebo a month later	Biological: RSVpreF Vaccine; RSV Vaccine; Other: Placebo; Placebo; Biological: Seasonal Inactivated Influenza Vaccine; SIIV
Experimental: Sequential Administration Group Placebo and SIIV followed by RSVpreF a month later	Biological: RSVpreF Vaccine; RSV Vaccine; Other: Placebo; Placebo; Biological: Seasonal Inactivated Influenza Vaccine; SIIV

Outcome Measures

Primary Outcome Measures

1. Local reactions (redness, swelling, and pain at the injection site) self-reported on e-diaries [7 days after each vaccination]

   The percentage of participants reporting prompted local reactions within 7 days after vaccination with RSVpreF or placebo.

2. Systemic events (fever, fatigue, headache, nausea, vomiting, diarrhea, muscle pain, and joint pain) self-reported on e-diaries [7 days after each vaccination]

   The percentage of participants reporting prompted systemic events within 7 days after vaccination with RSVpreF or placebo.

3. Adverse Events [1 month after each vaccination]

   The percentage of participants reporting AEs within 1 month after each vaccination.

4. Serious Adverse Events [1 month after each vaccination]

   The percentage of participants reporting SAEs within 1 month after each vaccination.

5. RSV A and RSV B Neutralizing Titers [1 month after each vaccination]

   Geometric Mean Ratio of NTs at 1 month after vaccination with RSVpreF for each RSV subfamily (A or B) in RSVpreF + SIIV to RSVpreF alone (sequential-administration group)

6. SIIV Strain-specific HAI titers or H3N2-neutralizing antibody titers [1 month after vaccination with SIIV]

   Geometric Mean Ratio of the strain-specific HAI (or H3N2-neutralizing antibody) titers 1 month after vaccination with SIIV in the coadministration group to the corresponding HAI (or H3N2-neutralizing antibody) titers in the sequential-administration group

Secondary Outcome Measures

1. RSV A and RSV B Neutralizing Titers expressed as Geometric Mean Titers (GMTs) [From Day 1 up to Month 2 visit]

   Geometric mean of the NTs for RSV A and RSV B before vaccination and at each applicable visit after vaccination with RSVpreF.

2. RSV A and RSV B Neutralizing Titers expressed as Geometric Mean Fold Rise (GMFR) [From Day 1 up to Month 2 visit]

   Geometric Mean Fold Rise of the NTs for RSV A and RSV B before vaccination and at each applicable visit after vaccination with RSVpreF.

3. Strain-specific HAI titers or H3N2-neutralizing antibody titers expressed as Geometric Mean Titers (GMTs) [Before and 1 month after vaccination with SIIV]

   Geometric Mean Titers before vaccination and 1 month after vaccination with SIIV.

4. Strain-specific HAI titers or H3N2-neutralizing antibody titers expressed as GMFRs [Before and 1 month after vaccination with SIIV]

   Geometric Mean Fold Rise of strain-specific HAI titers (or H3N2-neutralizing antibody titers if interpretable H3N2-HAI titers cannot be obtained) before vaccination and 1 month after vaccination with SIIV.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male and female participants ≥65 years of age at the time of consent.

2. Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e diary for 7 days after each study vaccination.

3. Healthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for inclusion in the study.

4. Capable of giving signed informed consent

Exclusion Criteria:

1. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection.

2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.

3. Allergy to egg proteins (egg or egg products) or chicken proteins.

4. History of Guillain-Barré syndrome.

5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.

6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

7. Other 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.

8. Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt throughout the study of nonstudy RSV vaccine.

9. Previous vaccination with any influenza vaccine within 6 months before study intervention administration, or planned receipt of any nonstudy licensed or investigational influenza vaccine during study participation.

10. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.

11. Individuals who receive chronic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids (<20 mg/day of prednisone or equivalent) have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroid use is permitted.

12. Current alcohol abuse or illicit drug use.

13. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s)

14. Participation in other studies involving investigational product(s) within 28 days prior to consent and/or during study participation

15. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paratus Clinical Research Canberra	Bruce	Australian Capital Territory	Australia	2617
2	Paratus Clinical Research Western Sydney	Blacktown	New South Wales	Australia	2148
3	Emeritus Research	Botany	New South Wales	Australia	2019
4	Genesis Research Services	Broadmeadow	New South Wales	Australia	2292
5	Northern Beaches Clinical Research	Brookvale	New South Wales	Australia	2100
6	Northside Health	Coffs Harbour	New South Wales	Australia	2450
7	Holdsworth House Medical Practice	Darlinghurst	New South Wales	Australia	2010
8	Paratus Clinical Research Central Coast	Kanwal	New South Wales	Australia	2259
9	The AIM Centre / Hunter Diabetes Centre	Merewether	New South Wales	Australia	2291
10	John Hunter Hospital	New Lambton Heights	New South Wales	Australia	2305
11	Scientia Clinical Research	Randwick	New South Wales	Australia	2031
12	Australian Clinical Research Network	Sydney	New South Wales	Australia	NSW 2035
13	Westmead Hospital	Westmead	New South Wales	Australia	2145
14	Paratus Clinical Research Brisbane	Albion	Queensland	Australia	4010
15	Core Research Group	Brisbane	Queensland	Australia	4064
16	Griffith University	Gold Coast Campus	Queensland	Australia	4222
17	Nucleus Network Brisbane	Herston	Queensland	Australia	4006
18	Mackay Hospital and Health Service	Mackay	Queensland	Australia	4740
19	USC Clinical Trials Moreton Bay	Morayfield	Queensland	Australia	4506
20	USC Clinical Trials Centre	Sippy Downs	Queensland	Australia	4556
21	AusTrials Taringa	Taringa	Queensland	Australia	4068
22	Core Research Group	Taringa	Queensland	Australia	4068
23	AusTrials Wellers Hill	Tarragindi	Queensland	Australia	4121
24	CMAX Clinical Research Pty Ltd	Adelaide	South Australia	Australia	5000
25	University of Tasmania	Hobart	Tasmania	Australia	7000
26	Box Hill Hospital	Box Hill	Victoria	Australia	3128
27	Emeritus Research	Camberwell	Victoria	Australia	3124
28	Barwon Health	Geelong	Victoria	Australia	3220
29	Doctors of Ivanhoe	Ivanhoe	Victoria	Australia	3079
30	Nucleus Network Melbourne	Melbourne	Victoria	Australia	3004
31	Institute for Respiratory Health	Nedlands	Western Australia	Australia	6009
32	Latitude Clinical Research	Spearwood	Western Australia	Australia	6163

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05301322
• Other Study ID Numbers: C3671006
• First Posted: Mar 29, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Respiratory tract infection; RSV; vaccine; older adults
• Additional relevant MeSH terms: Vaccines

Study Results

No Results Posted as of Jul 11, 2022