Last updated: 12/22/2024 12:10:10
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
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.This study also evaluated 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.
Primary purpose:
Prevention
Trial design:
Sequential Assignment
Masking:
Double (Participant, Care Provider)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: From Day 1 up to Day 180 (Follow-up)
Maximum Body Temperature over 7 days Post-vaccination
Timeframe: Up to 7 Days Post-vaccination
Number of participants with Solicited Local Reactions
Timeframe: From Day 1 up to Day 7
Number of participants with Solicited Systemic Reactions
Timeframe: From Day 1 up to Day 7
Secondary outcomes:
Percentage of Participants with Serotype-specific Immunoglobulin G (IgG) Concentration of greater than or equal to (>=) 0.35 microgram per milliliter (µg/mL)
Timeframe: On Day 1 and Day 30
Percentage of Participants with Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer >= Lower Limit of Quantification (LLOQ)
Timeframe: On Day 1 and Day 30
Geometric Mean Titer (GMT) for Serotype-specific OPA
Timeframe: On Day 1 and Day 30
Interventions:
Enrollment:
75
Primary completion date:
2022-06-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dorota Borys, Richard Rupp, Ronald Smulders, Gurunadh R Chichili, Laura L Kovanda, Vicki Santos, Frank Malinoski, George Siber, Richard Malley, Shite Sebastian. Safety, tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine in toddlers: A phase 1 randomized controlled trial.. Vaccine. 2024-Apr-11;42(10): 2560-2571.
DOI: 10.1016/j.vaccine.2024.02.001
PMID: 38360475
Medical condition
healthy volunteers, Pneumonia, Bacterial, Pneumococcal disease
Product
Not applicable
Collaborators
Affinivax Inc.
Study date(s)
September 2020 to April 2022
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
12 - 15 Months
Accepts healthy volunteers
Yes
- 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 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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-inflammatory drugs (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 location(s)
Location
Dermatology Trial Associates
Bryant, Arkansas, United States, 72022
Status
Study Complete
Location
Emmaus Research Center, Inc
Anaheim, California, United States, 92804
Status
Study Complete
Location
Madera Family Medical Group
Madera, California, United States, 93637
Status
Study Complete
Location
Ctr Clin Trials San Gabriel
West Covina, California, United States, 91790
Status
Study Complete
Location
Gentle Medicine Associates
Boynton Beach, Florida, United States, 33435
Status
Study Complete
Showing 1 - 6 of 48 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2022-06-04
Actual study completion date
2022-06-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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