SAFETY AND TOLERABILITY OF V114 IN HEALTHY INFANTS
- Conditions
- -J13 Pneumonia due to Streptococcus pneumoniaePneumonia due to Streptococcus pneumoniaeJ13
- Registration Number
- PER-051-18
- Lead Sponsor
- Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 183
1.Be healthy (based on a review of medical history and physical examination) based on the clinical judgement of the investigator.
2.Be male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent.
3.Have a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
Please refer to the protocol for more information.
1.Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
2.Has a known hypersensitivity to any component of the PCV or any diphtheria toxoid containing vaccine.
3.Had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
4.Has a known or suspected impairment of immunological function.
5.Has a history of congenital or acquired immunodeficiency.
6.Has or his/her mother has a documented human immunodeficiency virus (HIV) infection.
7.Has known or history of functional or anatomic asplenia.
8.Has failure to thrive based on the clinical judgement of the investigator.
9.Has a known coagulation disorder contraindicating intramuscular vaccination.
10.Has a history of autoimmune disease.
11.Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
12.Has received a dose of any pneumococcal vaccine prior to study entry.
13.Meets one or more of the following systemic corticosteroid exclusion criteria:
a. Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days
and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization.
b. Has received systemic corticosteroids within 14 days prior to the first dose of study vaccine at randomization.
c. Is expected to require systemic corticosteroids within 30 days after each vaccination during conduct of the study.
14.Has received other licensed non-live vaccines within the 14 days before receipt of first dose of study vaccine.
15.Has received a licensed live virus vaccine within the 30 days before receipt of first dose of study vaccine.
16.Has received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine.
17.Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case
basis for approval by the Sponsor.
18. Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
19.Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
Please refer to the protocol for more information.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Evaluation and quantification of AEs, notified and recorded in the electronic Vaccination Card (eVRC)<br>Measure:Proportion of participants with Injection-site Adverse Events (AE), Systemic Adverse Events and Vaccine-related Serious Adverse Event<br>Timepoints:From Day 1 through day 14 for injection-site and systemic AEs.<br>Through completion of study participation for SAEs.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Descriptive Statistics (exponentiating the estimates of the mean of the natural log values)<br>Measure:Premature infant immunogenicity substudy only: Anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 15 serotypes contained in V114.<br>Timepoints:At 30 days post dose 3, prior to Dose 4 and at 30 days post dose 4.<br>;<br>Outcome name:Clopper and Pearson Method<br>Measure:Premature infant immunogenicity substudy only: Anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) response<br>Rates for the 15 serotypes contained in V114.<br><br>Timepoints:At 30 days post dose 3, prior to Dose 4 and at 30 days post dose 4.<br>