Phase IIB Clinical trial to evaluate the safety and immune effectiveness of V114 in healthy infants
- Conditions
- Prevention of pneumococcal diseaseMedDRA version: 20.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2016-001117-25-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1051
1.Be healthy (based on medical history and physical examination) male or female infant approximately 2 months of age (42 days to 90 days), inclusive
2.Have a parent/legal guardian who understands the trial procedures, alternate treatments available, and risks involved with the trial.
3.Have a parent/legal guardian who is able to read, understand, and complete the VRC and voluntarily agree to participate by giving written informed consent.
4.A parent/legal guardian also acknowledges that they: a) will attend all scheduled visits b) comply with the trial procedures, and c) have access to a telephone.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1050
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
If the subject meets criteria marked with an asterisk (*), the Day 1 Visit may be rescheduled for a time when these criteria are not met.
1.Had prior administration of any pneumococcal vaccine
2.Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, 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 trial vaccine
4.Has a known or suspected impairment of immunological function
5. Has a history of congenital or acquired immunodeficiency (e.g. splenomegaly)
6.Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
7.Has or his/her mother has a documented hepatitis B surface antigen – positive test
8.Has known or history of functional or anatomic asplenia
9.Has a history of failure to thrive
10.Has known or history of a coagulation disorder contraindicating intramuscular vaccination
11.Has a history of autoimmune disease including systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, and other autoimmune disorders
12.Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
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/d for persons weighing > 10 kg) for = 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization b)Has received systemic corticosteroids within 14 days prior to the first dose of vaccine at randomization c) Is expected to require systemic corticosteroids within 30 days after each vaccination during conduct of the trial
14.*Has received other licensed non-live vaccines within the 14 days before receipt of first dose of trial vaccine
15.*Has received a licensed live virus vaccine within the 30 days prior to receipt of first dose of trial vaccine
16.Had prior receipt of a blood transfusion or blood products, including immunoglobulins
17.Has participated in another clinical trial of an investigational product before the beginning or anytime during the duration of the current clinical trial. Subjects enrolled in observational studies may be included; these will be reviewed on a caseby- case basis for approval by the SPONSOR
18.Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
19.Cannot be adequately followed for safety according to the protocol plan
20.Has a parent/legal guardian who is unlikely to adhere to trial procedures, keep appointments, or is planning to relocate during the trial
21.Has any other reason that in the opinion of the investigator may interfere with the e
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method