| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (toddlers), Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator |
|
| E.1.1.1 | Medical condition in easily understood language |
| Healthy volunteers (toddlers), Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10078416 |
| E.1.2 | Term | Invasive bacterial infection |
| E.1.2 | System Organ Class | 100000004862 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To evaluate the safety and tolerability of 3 dose levels of ASP3772, in comparison to the active comparator Prevnar 13® (PCV13) in toddlers approximately 12 to 15 months of age who have previously been administered the routine 3-dose series of PCV13. |
|
| E.2.2 | Secondary objectives of the trial |
| To evaluate the immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator (PCV13) in toddlers approximately 12 to 15 months of age who have previously been administered the routine 3-dose series of PCV13. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulation (e.g., Health Insurance Portability and Accountability Act authorization) must be obtained from the subject’s parent/legal guardian.
2. Subject is a healthy toddler, approximately 12 to 15 months of age who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
3. 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]).
4. Subject’s parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
5. 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.
6. Subject’s parent/legal guardian has access to a telephone.
7. Subject’s parent/legal guardian agrees not to enroll subject in another interventional study while participating in the present study. |
|
| E.4 | Principal exclusion criteria |
1. Subject has a known hypersensitivity to any vaccine.
2. 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.
3. Subject has or his/her mother has known human immunodeficiency virus infection or
known to be hepatitis B surface antigen-positive.
4. Subject has functional or anatomic asplenia.
5. Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
6. 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, as judged by the investigator.
7. Subject has any active malignancy or history of malignancy.
8. 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.
9. 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.
10. Subject has previously received an approved (other than PCV13) or investigational pneumococcal vaccine.
11. Subject has had any prior receipt of a blood transfusion or blood products, including immunoglobulins.
12. Subject has received investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
13. Subject has received a systemically absorbed antibacterial agent within 7 days prior to study vaccination.
14. Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
15. Subject has received acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) within 24 hours prior to receipt of study vaccine.
16. Subject has a coagulation disorder.
17. Subject’s parent/legal guardian is (in the opinion of the investigator) 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.
18. Subject who has a condition, which, in the opinion of the investigator, makes the subject unsuitable for study participation.
19. Subject’s parent(s)/legal guardian is an employee of APGD, the study-related contract research organizations (CROs) or the study site. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
● Treatment-emergent adverse events (TEAEs)
● Body temperature
● Reactogenicity using solicited adverse reactions for up to 7 days postvaccination. These include local and systemic reactions with a predefined grading scale. Local reactions are tenderness, movement restriction, redness/erythema and swelling and induration.
Systemic reactions are vomiting, diarrhea, fever, irritability, decrease of appetite and increase or decrease in sleep. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
● The proportion of subjects achieving a serotype-specific anticapsular polysaccharide (PS) immunoglobulin G (IgG) concentration of ≥ 0.35 μg/mL and the difference between each ASP3772 dose level and PCV13.
● The proportion of subjects achieving a serotype-specific opsonophagocytic activity (OPA) antibody titer ≥ 1:8 and the difference in the proportion between each dose level of ASP3772 and PCV13.
● The geometric mean titer (GMT) for serotype-specific OPA postvaccination. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Screening/Dosing (prior to administration of study vaccine) and day 30 (visit 3) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| tolerability, Immunogenicity |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | Yes |
| E.7.1.3.1 | Other trial type description |
|
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 6 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| completion of the last visit (day 180) for all subjects who do not terminate the study permanently. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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