Respiratory Tract InfectionPhase 2NCT03572062

A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

A Phase 2 study testing Formulation A, Formulation B and Formulation C in people with Respiratory Tract Infection, run by Pfizer at 16 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine administered12 months after the initial dose. Read more about this study

Who is it for?: Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Tract Infection
What is being tested?: Formulation A, Formulation B and Formulation C
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 317 participants
Where: 16 sitesin 2 countries
Study dates: 5 Jun 2018to 19 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 85 years
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).
Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).

Who cannot join

Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Previous vaccination with any licensed or investigational RSV vaccine before enrollment into the study, or planned receipt throughout the study of nonstudy RSV vaccine.
Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration (applies to Primary Study Cohort - Stages 1 and 2).
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s), including natural rubber latex. In addition, a history of severe allergic reaction (eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg or egg products) or chicken proteins.

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Subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration.Inhaled/nebulized, intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are permitted.
Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome,multiple sclerosis, Sjögren syndrome, idiopathic thrombocytopenic purpura, autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Female subjects of childbearing potential or who are pregnant or breastfeeding; fertile male subjects who are unwilling to use a highly effective method of contraception for at least 28 days after the last dose of investigational product.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Planned donation of blood volumes of approximately 470 mL within 12 weeks after Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

Australia12 sites

Eastern Health
Box Hill, Victoria, 3128
Emeritus Research Pty. Ltd.
Camberwell, Victoria, 3124
Monash Medical Centre
Clayton, Victoria, 3168
Barwon Health
Geelong, Victoria, 3220
Doctors of Ivanhoe
Ivanhoe, Victoria, 3079
Australian Clinical Research Network
Maroubra, New South Wales, 2035
AIM Centre (Hunter Diabetes Centre)
Merewether, New South Wales, 2291
Institute for Respiratory Health
Nedlands, Western Australia, 6009
TrialsWest
Spearwood, Western Australia, 6163
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Data Health Australia Pty Limited (Trading as AusTrials)
Taringa, Queensland, 4068
Westmead Hospital (Infectious Diseases and Microbiology)
Westmead, New South Wales, 2145

Other trials in Australia

United States4 sites

Synexus Clinical Research US
Fremont, Nebraska, 68025
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Optimal Research, LLC
Peoria, Illinois, 61614
Qps Mra, Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS

In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.

Read the detailed description

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with SIIV. Healthy male and female subjects between 65 to 85 years of age will be enrolled. Subjects will receive 2 intramuscular injections to assess the concomitant administration of SIIV when given to subjects receiving one of the 3 RSV vaccine dose-level candidates formulated with or without an adjuvant.

If interim support implementation of revaccination, invited, consenting subjects will be revaccinated with the same dose and formulation of the RSV vaccine or placebo received at Visit 1, concomitantly with SIIV. The safety, tolerability, and immunogenicity of the second dose will be evaluated through 12 months after revaccination.

62 subjects will be randomized 1:1 to receive a dose of high dose adjuvanted RSV vaccine or placebo followed by a second dose 2 months later. Safety, tolerability, and immunogenicity will be evaluated. The subjects will be enrolled before the influenza season. There will be no concomitant SIIV administration.

Conditions: Respiratory Tract Infection
Being tested: Formulation A, Formulation B, Formulation C, Placebo
Keywords: Respiratory tract infection, RSV, Adjuvant, vaccine
Medical subject headings: Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Formulation ABiological
RSV vaccine
Formulation BBiological
Adjuvanted RSV vaccine
Formulation CBiological
RSV vaccine
PlaceboBiological
Placebo

Study groups in NCT03572062
Study group	Role	What they receive
Arm 1	Experimental	Low dose formulation A and SIIV Receives: Biological: Formulation A
Arm 2	Experimental	Low dose formulation B and SIIV Receives: Biological: Formulation B
Arm 3	Experimental	Mid dose formulation A and SIIV Receives: Biological: Formulation A
Arm 4	Experimental	Mid dose formulation B and SIIV Receives: Biological: Formulation B
Arm 5	Experimental	High dose formulation A and SIIV Receives: Biological: Formulation A
Arm 6	Experimental	High dose formulation B and SIIV Receives: Biological: Formulation B
Arm 7	Experimental	High dose formulation C and SIIV Receives: Biological: Formulation C
Arm 8	Placebo comparator	Placebo and SIIV Receives: Biological: Placebo
M0M2 Arm 1	Experimental	High dose formulation B Receives: Biological: Formulation B
M0M2 Arm 2	Placebo comparator	Placebo Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than [>] 21). 1 measuring device unit = 0.5 centimeter (cm) and graded as: mild (2.5 to 5.0 cm), moderate (greater than [>] 5.0 to 10.0 cm), and severe (>10 cm). Pain at injection site was graded as: mild (did not interfere with activity), moderate (interferes with activity) and severe (prevented daily activity).
Measured: Within 14 days after Vaccination 1
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees [deg] Celsius [C]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Vomiting was graded as: mild (1-2 times in 24 hours [h]), moderate (>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h).
Measured: Within 14 days after Vaccination 1
Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events.
Measured: Within 1 month after Vaccination 1
Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Measured: Up to 12 months after Vaccination 1

Secondary outcomes (2)

Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. Titers above the lower limit of quantitation (LLOQ) were considered accurate and their quantitated values were reported. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5 × LLOQ.
Measured: Before vaccination and 1 Month after Vaccination 1
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
The HAI and neutralizing titer LLOQ value for each strain was 1:10. Assay results below the LLOQ were set to 0.5 × LLOQ. The analysis was performed on following strains: H1N1 A/Michigan, H3N2 A/Brisbane, B/Phuket for HAI and H3N2/Brisbane for neutralizing assay.
Measured: Before vaccination and 1 Month after Vaccination 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 201819 Aug 2020

First posted28 Jun 2018
Study start5 Jun 2018
Primary completion23 Jun 2020
Study completion19 Aug 2020

Why it stopped: Study halted prematurely by sponsor and will not resume, participants are no longer being examined or receiving intervention.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Tract InfectionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03572062
Sponsor's protocol ID: C3671002
Other IDs: RSV ADJUVANT
Status last verified: Aug 2021
First submitted: 1 Jun 2018
Last updated: 26 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Baber J, Arya M, Moodley Y, Jaques A, Jiang Q, Swanson KA, Cooper D, Maddur MS, Loschko J, Gurtman A, Jansen KU, Gruber WC, Dormitzer PR, Schmoele-Thoma B. A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. J Infect Dis. 2022 Dec 13;226(12):2054-2063. doi: 10.1093/infdis/jiac189.
PubMed 35543281

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS
ClinicalTrials.gov ID: NCT03572062
Acronym / sponsor ID: C3671002
Conditions: Respiratory Tract Infection
Keywords: Respiratory tract infection, RSV, Adjuvant, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study halted prematurely by sponsor and will not resume, participants are no longer being examined or receiving intervention.
Enrolment: 317 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 5 Jun 2018 (actual)
Primary completion: 23 Jun 2020 (actual)
Study completion: 19 Aug 2020 (actual)
First posted: 28 Jun 2018 (actual)
Results: Posted 26 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10
Model description: Parallel

Arm	Type	Receives
Arm 1	Experimental	Biological: Formulation ALow dose formulation A and SIIV
Arm 2	Experimental	Biological: Formulation BLow dose formulation B and SIIV
Arm 3	Experimental	Biological: Formulation AMid dose formulation A and SIIV
Arm 4	Experimental	Biological: Formulation BMid dose formulation B and SIIV
Arm 5	Experimental	Biological: Formulation AHigh dose formulation A and SIIV
Arm 6	Experimental	Biological: Formulation BHigh dose formulation B and SIIV
Arm 7	Experimental	Biological: Formulation CHigh dose formulation C and SIIV
Arm 8	Placebo comparator	Biological: PlaceboPlacebo and SIIV
M0M2 Arm 1	Experimental	Biological: Formulation BHigh dose formulation B
M0M2 Arm 2	Placebo comparator	Biological: PlaceboPlacebo

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).
Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).

Key exclusion criteria (14 listed)

Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Previous vaccination with any licensed or investigational RSV vaccine before enrollment into the study, or planned receipt throughout the study of nonstudy RSV vaccine.
Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration (applies to Primary Study Cohort - Stages 1 and 2).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Formulation ARSV vaccine	Biological	Arm 1, Arm 3, Arm 5
Formulation BAdjuvanted RSV vaccine	Biological	Arm 2, Arm 4, Arm 6, M0M2 Arm 1
Formulation CRSV vaccine	Biological	Arm 7
PlaceboPlacebo	Biological	Arm 8, M0M2 Arm 2

Primary outcome

Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Time frame: Within 14 days after Vaccination 1
Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than [>] 21). 1 measuring device unit = 0.5 centimeter (cm) and graded as: mild (2.5 to 5.0 cm), moderate (greater than [>] 5.0 to 10.0 cm), and severe (>10 cm). Pain at injection site was graded as: mild (did not interfere with activity), moderate (interferes with activity) and severe (prevented daily activity).
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Time frame: Within 14 days after Vaccination 1
Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees [deg] Celsius [C]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Vomiting was graded as: mild (1-2 times in 24 hours [h]), moderate (>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h).
Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
Time frame: Within 1 month after Vaccination 1
An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events.
Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1
Time frame: Up to 12 months after Vaccination 1
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.

2 secondary outcomes

Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
Time frame: Before vaccination and 1 Month after Vaccination 1
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
Time frame: Before vaccination and 1 Month after Vaccination 1

Results and safety

Results posted to the registry on 26 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV	32	32
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV	32	32
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV	32	32
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV	31	31
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV	32	31
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV	32	28
Primary Cohort: RSVpreF 240 mcg + SIIV	32	31
Primary Cohort: Placebo + SIIV	31	30
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3	32	0
Month-0, Month-2 Cohort: Placebo	31	0

Primary outcome: Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1

Time frame: Within 14 days after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV n = 30	Primary Cohort: RSVpreF 240 mcg + SIIV n = 32	Primary Cohort: Placebo + SIIV n = 30
Pain at Injection Site: Mild	32.3 (16.7 to 51.4)	28.1 (13.7 to 46.7)	3.1 (0.1 to 16.2)	25.8 (11.9 to 44.6)	22.6 (9.6 to 41.1)	16.7 (5.6 to 34.7)	18.8 (7.2 to 36.4)	6.7 (0.8 to 22.1)
Pain at Injection Site: Moderate	0 (0.0 to 11.2)	3.1 (0.1 to 16.2)	0 (0.0 to 10.9)	3.2 (0.1 to 16.7)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	3.3 (0.1 to 17.2)
Pain at Injection Site: Severe	0 (0.0 to 11.2)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	0 (0.0 to 11.2)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)
Redness: Mild	3.2 (0.1 to 16.7)	0 (0.0 to 10.9)	3.1 (0.1 to 16.2)	0 (0.0 to 11.2)	3.2 (0.1 to 16.7)	0 (0.0 to 11.6)	3.1 (0.1 to 16.2)	0 (0.0 to 11.6)
Redness: Moderate	3.2 (0.1 to 16.7)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	0 (0.0 to 11.2)	3.2 (0.1 to 16.7)	0 (0.0 to 11.6)	3.1 (0.1 to 16.2)	0 (0.0 to 11.6)
Redness: Severe	0 (0.0 to 11.2)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	0 (0.0 to 11.2)	3.2 (0.1 to 16.7)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)
Swelling: Mild	3.2 (0.1 to 16.7)	3.1 (0.1 to 16.2)	3.1 (0.1 to 16.2)	0 (0.0 to 11.2)	3.2 (0.1 to 16.7)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	3.3 (0.1 to 17.2)
Swelling: Moderate	0 (0.0 to 11.2)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	3.2 (0.1 to 16.7)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)

Population analysed: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Primary cohort only.

Primary outcome: Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1

Time frame: Within 14 days after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV n = 30	Primary Cohort: RSVpreF 240 mcg + SIIV n = 32	Primary Cohort: Placebo + SIIV n = 30
Fever: Mild	0 (0.0 to 11.2)	0 (0.0 to 10.9)	9.4 (2.0 to 25.0)	0 (0.0 to 11.2)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)
Fever: Moderate	3.2 (0.1 to 16.7)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	3.2 (0.1 to 16.7)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)
Fever: Severe	0 (0.0 to 11.2)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	0 (0.0 to 11.2)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)
Fever: Grade 4	0 (0.0 to 11.2)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	0 (0.0 to 11.2)	0 (0.0 to 11.2)	0 (0.0 to 11.6)	0 (0.0 to 10.9)	0 (0.0 to 11.6)
Nausea: Mild	9.7 (2.0 to 25.8)	3.1 (0.1 to 16.2)	3.1 (0.1 to 16.2)	0 (0.0 to 11.2)	6.5 (0.8 to 21.4)	0 (0.0 to 11.6)	6.3 (0.8 to 20.8)	10.0 (2.1 to 26.5)
Nausea: Moderate	0 (0.0 to 11.2)	0 (0.0 to 10.9)	0 (0.0 to 10.9)	6.5 (0.8 to 21.4)	3.2 (0.1 to 16.7)	0 (0.0 to 11.6)	0 (0.0 to 10.9)

Primary outcome: Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1

Time frame: Within 1 month after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV n = 30	Primary Cohort: RSVpreF 240 mcg + SIIV n = 32	Primary Cohort: Placebo + SIIV n = 30
Value	21.9 (9.3 to 40.0)	21.9 (9.3 to 40.0)	34.4 (18.6 to 53.2)	29.0 (14.2 to 48.0)	25.8 (11.9 to 44.6)	23.3 (9.9 to 42.3)	21.9 (9.3 to 40.0)	16.7 (5.6 to 34.7)

Population analysed: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Data for this outcome measure was planned to be collected for Primary cohort only.

Primary outcome: Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1

Time frame: Up to 12 months after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV n = 32	Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV n = 31	Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV n = 30	Primary Cohort: RSVpreF 240 mcg + SIIV n = 32	Primary Cohort: Placebo + SIIV n = 30
MAEs	46.9 (29.1 to 65.3)	59.4 (40.6 to 76.3)	46.9 (29.1 to 65.3)	51.6 (33.1 to 69.8)	54.8 (36.0 to 72.7)	60.0 (40.6 to 77.3)	50.0 (31.9 to 68.1)	50.0 (31.3 to 68.7)
SAEs	6.3 (0.8 to 20.8)	12.5 (3.5 to 29.0)	12.5 (3.5 to 29.0)	12.9 (3.6 to 29.8)	16.1 (5.5 to 33.7)	13.3 (3.8 to 30.7)	12.5 (3.5 to 29.0)	10.0 (2.1 to 26.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV	2 of 32 (6.3%)	17 of 32 (53.1%)	0 of 32
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV	4 of 32 (12.5%)	17 of 32 (53.1%)	0 of 32
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV	4 of 32 (12.5%)	21 of 32 (65.6%)	0 of 32
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV	4 of 31 (12.9%)	21 of 31 (67.7%)	0 of 31
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV	5 of 31 (16.1%)	17 of 31 (54.8%)	0 of 31
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV	4 of 30 (13.3%)	12 of 30 (40%)	1 of 30
Primary Cohort: RSVpreF 240 mcg + SIIV	4 of 32 (12.5%)	25 of 32 (78.1%)	0 of 32
Primary Cohort: Placebo + SIIV	3 of 30 (10%)	14 of 30 (46.7%)	0 of 30
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3	6 of 32 (18.8%)	28 of 32 (87.5%)	0 of 32
Month-0, Month-2 Cohort: Placebo	5 of 31 (16.1%)	23 of 31 (74.2%)	0 of 31

Limitations and caveats (from the sponsor): Study follow up of the Month-0, Month-2 cohort was terminated early due to sponsor decision, with all participants followed up through 6 months after Vaccination 2.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35543281Baber J, Arya M, Moodley Y, Jaques A, Jiang Q, Swanson KA, Cooper D, Maddur MS, Loschko J, Gurtman A, Jansen KU, Gruber WC, Dormitzer PR, Schmoele-Thoma B. A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. J Infect Dis. 2022 Dec 13;226(12):2054-2063. doi: 10.1093/infdis/jiac189.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Formulation A, Formulation B and Formulation C in people with Respiratory Tract Infection, run by Pfizer at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 (time frame: Within 14 days after Vaccination 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03572062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.