Healthy VolunteersPhase 1NCT04525599

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

A Phase 1 study testing ASP3772 and PCV13 in people with Healthy Volunteers and Pneumococcal Disease, run by Affinivax, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13. Read more about this study

Who is it for?: Ages 12 to 15 monthsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Pneumococcal Disease
What is being tested?: ASP3772 and PCV13
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 17 sitesUnited States
Study dates: 22 Sep 2020to 6 Apr 2022
Phase: Phase 1
Are there results?: None posted in the registry

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 12 to 15 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subject is a healthy toddler who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
Subject is afebrile within the last 48 hours (temperature measured orally is < 100 °F [37.8°C]; measured rectally or tympanic is < 101 °F [38.3°C]; measured in an axillary position or temporal is < 98.4 °F [36.9°C]).
Subject's parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
Subject's parent/legal guardian along with the subject is able and is willing to attend all scheduled visits and to comply with the study procedures.
Subject's parent/legal guardian has access to a telephone.
Subject's parent/legal guardian agrees not to enroll subject in another interventional study while participating in the present study.

Who cannot join

Subject has a known hypersensitivity to any vaccine.
Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs, known or suspected impairment of immunological function or a history of congenital or acquired immunodeficiency.
Subject has or his/her mother has known human immunodeficiency virus infection or known to be hepatitis B surface antigen-positive.
Subject has functional or anatomic asplenia.
Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.

Show all 19Show fewer

Subject has any active malignancy or history of malignancy.
Subject has been in receipt of intramuscular, oral, intravenous, inhaled or intranasal corticosteroid treatment within 2 weeks prior to study vaccination or is planned to receive these medications within 4 weeks after study vaccination. Note: Use of topical corticosteroids is permitted.
Subject has received any live-attenuated vaccines within 4 weeks prior to receipt of the study vaccine or inactivated vaccines within 2 weeks prior to receipt of study vaccine.
Subject has previously received an approved (other than PCV13) or investigational pneumococcal vaccine.
Subject has had any prior receipt of a blood transfusion or blood products, including immunoglobulins.
Subject has received investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
Subject has received a systemically absorbed antibacterial agent within 7 days prior to study vaccination.
Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
Subject has received acetaminophen or nonsteroidal anti-inflammatorydrugs (NSAIDs) within 24 hours prior to receipt of study vaccine.
Subject has a coagulation disorder.
Subject's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study and the subject cannot be adequately followed for safety according to the protocol.
Subject who has a condition which makes the subject unsuitable for study participation.
Subject's parent(s)/legal guardian is an employee of Astellas Pharma Global Development Inc., the study-related contract research organizations (CROs), or the study site.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Emmaus Research Center, Inc
Anaheim, California, 92804
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Meridian Clinical Research
Baton Rouge, Louisiana, 70806
Gentle Medicine Associates
Boynton Beach, Florida, 33435
Dermatology Trial Associates
Bryant, Arkansas, 72022
Coastal Pediatric Associates
Charleston, South Carolina, 29414
Pediatrics Medical Associates
East Norriton, Pennsylvania, 19401
University of Texas Medical Branch
Galveston, Texas, 77555
Houston Clinical Research Associates
Houston, Texas, 77090
The Childrens Clinic
Jonesboro, Arkansas, 72401
Tanner Clinic
Layton, Utah, 84041
Madera Family Medical Group
Madera, California, 93637
Pediatric Care
Provo, Utah, 84604
MultiCare Institute
Spokane, Washington, 99202
PMG Research
Statesville, North Carolina, 28625
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127
Ctr Clin Trials San Gabriel
West Covina, California, 91790

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.

Read the detailed description

After screening, participants will be randomized to ASP3772 or PCV13 on Day 1. A single dose of ASP3772 will be administered on Day 1 as an injection into the right or left thigh muscle at one of three dose levels. The participants randomized to PCV13 will receive a single intramuscular injection of the approved dose of PCV13 into the right or left thigh muscle. All participants will remain at the study site for approximately 30 to 60 minutes following vaccination in order for study site personnel to evaluate any immediate reactions, if needed. The participant's parent/legal guardian will observe for reactions, including daily body temperature measurements and tolerability assessments, from Day 2 through Day 7 and record observed events in the electronic diary device.

All participants will have study visits on Day 7 (+ 1 day) and Day 30 (± 5 days) post-vaccination. The Day 7 visit may be conducted on site or by telephone call.The end-of-study visit will occur on Day 180 (± 14 days), which will be a safety follow-up by telephone call.

Conditions: Healthy Volunteers, Pneumococcal Disease
Being tested: ASP3772, PCV13
Keywords: Pneumococcal Disease, ASP3772, Pneumococcal vaccine, Vaccine
Medical subject headings: Pneumococcal Infections

What participants receive

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

ASP3772Biological
Intramuscular (IM) injection
PCV13Biological
Also called Prevnar 13
Intramuscular injection

Study groups in NCT04525599
Study group	Role	What they receive
Group 1, ASP3772 Low Dose	Experimental	Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a low-dose level. Receives: Biological: ASP3772
Group 1, PCV13 Comparator	Active comparator	Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1. Receives: Biological: PCV13
Group 2, ASP3772 Medium Dose	Experimental	Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a medium-dose level. Receives: Biological: ASP3772
Group 2, PCV13 Comparator	Active comparator	Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1. Receives: Biological: PCV13
Group 3, ASP3772 High Dose	Experimental	Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a high-dose level. Receives: Biological: ASP3772
Group 3, PCV13 Comparator	Active comparator	Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1. Receives: Biological: PCV13

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event (AE) observed after study vaccination and up to 30 days post-vaccination. A vaccine-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Measured: Up to Day 30
Number of Participants With Body Temperature Abnormalities and/or Adverse Events
Number of participants with potentially clinically significant body temperature abnormalities.
Measured: Up to Day 30
Reactogenicity Assessed by Number of Solicited Local Reactions
Local reactions are tenderness, movement restriction, redness/erythema and swelling and induration. Local reactogenicity will be evaluated at approximately 30 to 60 minutes post-dose by study site personnel and recorded in an electronic diary device by the participant's parent/legal guardian while at the study site on day 1. The participant's parent/legal guardian will observe reactogenicity and tolerability from day 2 through day 7, and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
Measured: Up to Day 7
Reactogenicity assessed by Number of Solicited Systemic Reactions
Systemic reactions are vomiting, diarrhea, fever, irritability, decrease of appetite and increase or decrease in sleep. Body temperature will be assessed pre-dose and approximately 30 to 60 minutes post-dose. The participant's parent/legal guardian will be asked to observe the systemic reactogenicity symptoms from day 2 through day 7 and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
Measured: Up to Day 7

Secondary outcomes (6)

Proportion of Participants Achieving a Serotype-specific Anticapsular Polysaccharide Immunoglobulin G (PS IgG) Concentration of ≥ 0.35 µg/mL for ASP3772
PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of ASP3772.
Measured: Up to 30 days
Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13
PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of PCV13.
Measured: Up to 30 days
Proportion of Participants Achieving a Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer ≥ 1:8 for ASP3772
OPA measure will be used to characterize the immunological response 30 days following administration of ASP3772.
Measured: Up to 30 days
Proportion of Participants Achieving a Serotype-specific OPA Antibody Titer ≥ 1:8 for PCV13
OPA measure will be used to characterize the immunological response 30 days following administration of PCV13.
Measured: Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for ASP3772
OPA measure will be used to characterize the immunological response 30 days following administration of ASP3772.
Measured: Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for PCV13
OPA measure will be used to characterize the immunological response 30 days following administration of PCV13.
Measured: Up to 30 days

Timeline

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

22 Sep 20206 Apr 2022

First posted25 Aug 2020
Study start22 Sep 2020
Primary completion6 Apr 2022
Study completion6 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04525599
Sponsor's protocol ID: 3772-CL-2001
Other IDs: 2019-004503-12, 2019
Status last verified: Jun 2022
First submitted: 21 Aug 2020
Last updated: 6 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
ClinicalTrials.gov ID: NCT04525599
Acronym / sponsor ID: 3772-CL-2001
Conditions: Healthy Volunteers, Pneumococcal Disease
Keywords: Pneumococcal Disease, ASP3772, Pneumococcal vaccine, Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Affinivax, Inc.Industry (pharma, biotech, devices)
Study start: 22 Sep 2020 (actual)
Primary completion: 6 Apr 2022 (actual)
Study completion: 6 Apr 2022 (actual)
First posted: 25 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, care provider)
Number of arms: 6

Arm	Type	Receives
Group 1, ASP3772 Low Dose	Experimental	Biological: ASP3772Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a low-dose level.
Group 1, PCV13 Comparator	Active comparator	Biological: PCV13Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
Group 2, ASP3772 Medium Dose	Experimental	Biological: ASP3772Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a medium-dose level.
Group 2, PCV13 Comparator	Active comparator	Biological: PCV13Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
Group 3, ASP3772 High Dose	Experimental	Biological: ASP3772Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a high-dose level.
Group 3, PCV13 Comparator	Active comparator	Biological: PCV13Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.

Who may qualify

Ages: 12 to 15 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subject is a healthy toddler who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
Subject is afebrile within the last 48 hours (temperature measured orally is < 100 °F [37.8°C]; measured rectally or tympanic is < 101 °F [38.3°C]; measured in an axillary position or temporal is < 98.4 °F [36.9°C]).
Subject's parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
Subject's parent/legal guardian along with the subject is able and is willing to attend all scheduled visits and to comply with the study procedures.
Subject's parent/legal guardian has access to a telephone.

Key exclusion criteria (19 listed)

Subject has a known hypersensitivity to any vaccine.
Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs, known or suspected impairment of immunological function or a history of congenital or acquired immunodeficiency.
Subject has or his/her mother has known human immunodeficiency virus infection or known to be hepatitis B surface antigen-positive.
Subject has functional or anatomic asplenia.
Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.

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
ASP3772Intramuscular (IM) injection	Biological	Group 1, ASP3772 Low Dose, Group 2, ASP3772 Medium Dose, Group 3, ASP3772 High Dose
PCV13Also: Prevnar 13Intramuscular injection	Biological	Group 1, PCV13 Comparator, Group 2, PCV13 Comparator, Group 3, PCV13 Comparator

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 30
A TEAE is defined as an adverse event (AE) observed after study vaccination and up to 30 days post-vaccination. A vaccine-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Number of Participants With Body Temperature Abnormalities and/or Adverse Events
Time frame: Up to Day 30
Number of participants with potentially clinically significant body temperature abnormalities.
Reactogenicity Assessed by Number of Solicited Local Reactions
Time frame: Up to Day 7
Local reactions are tenderness, movement restriction, redness/erythema and swelling and induration. Local reactogenicity will be evaluated at approximately 30 to 60 minutes post-dose by study site personnel and recorded in an electronic diary device by the participant's parent/legal guardian while at the study site on day 1. The participant's parent/legal guardian will observe reactogenicity and tolerability from day 2 through day 7, and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
Reactogenicity assessed by Number of Solicited Systemic Reactions
Time frame: Up to Day 7
Systemic reactions are vomiting, diarrhea, fever, irritability, decrease of appetite and increase or decrease in sleep. Body temperature will be assessed pre-dose and approximately 30 to 60 minutes post-dose. The participant's parent/legal guardian will be asked to observe the systemic reactogenicity symptoms from day 2 through day 7 and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).

6 secondary outcomes

Proportion of Participants Achieving a Serotype-specific Anticapsular Polysaccharide Immunoglobulin G (PS IgG) Concentration of ≥ 0.35 µg/mL for ASP3772
Time frame: Up to 30 days
Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13
Time frame: Up to 30 days
Proportion of Participants Achieving a Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer ≥ 1:8 for ASP3772
Time frame: Up to 30 days
Proportion of Participants Achieving a Serotype-specific OPA Antibody Titer ≥ 1:8 for PCV13
Time frame: Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for ASP3772
Time frame: Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for PCV13
Time frame: Up to 30 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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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.

Medical Director study director

Astellas Pharma Global Development, Inc.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP3772 and PCV13 in people with Healthy Volunteers and Pneumococcal Disease, run by Affinivax, Inc. at 17 sites in United States.

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 6 inclusion and 19 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: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Day 30). 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 NCT04525599.

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 6 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.