Safety and Immunogenicity of Catch-up Vaccination Regimens of V114
- Conditions
- Pneumococcal diseaseTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]MedDRA version: 20.0Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2018-003706-88-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
A participant will be eligible for inclusion in the study if the participant:
1. Is healthy (based on a review of medical history and physical examination) based on the clinical judgement of the investigator.
2. Is male or female, from 7 months to 17 years of age (inclusive), at the time of obtaining the informed consent/assent.
3. Not be pregnant or breastfeeding, and at least 1 of the following conditions applies:
a. Not be a woman of childbearing potential (WOCBP)
OR
b. A WOCBP must agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention.
4. Has 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. As appropriate based on local guidelines, the participant will also provide written informed assent for the study. The participant or the participant’s legally acceptable representative may also provide assent/consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
Are the trial subjects under 18? yes
Number of subjects for this age range: 600
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
The participant must be excluded from the study if the participant:
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 (defined as rectal, oral or tympanic temperature =38.1°C [=100.5°F] or axillary or temporal 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 bleeding disorder contraindicating intramuscular vaccination.
10. Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet’s disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
11. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
12. Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants =2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™, Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine.
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 or is expected to receive systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days prior to any dose of study vaccine.
c. Is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study.
14. *Has received other licensed non-live vaccines within 14 days before receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine.
15. *Has received a licensed live vaccine within 30 days before receipt of study vaccine.
16. Has received a blood transfusion or blood products, including immunoglobulins, within 6 months before receipt 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-bycase basis for approval by the Sponsor.
18. Has any other reason that, in the opinion of the investigator, may interfere with the evalu
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