CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study (NCT03384589) | Clinical Trial Compass
CompletedPhase 2/3
CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study
Canada248 participantsStarted 2018-08-23
Plain-language summary
This study is assessing if a reduced dosing schedule (1+1) of the 13-valent pneumococcal conjugate vaccine (PCV13) is non-inferior to the currently used schedule used in most of Canada.The vaccine is currently usually given as 3 doses at 2, 4 and 12 months of age. This study aims to find out if it is possible to achieve the same protection using just 2 doses, at 2 and 12 months.
Who can participate
Age range2 Months – 2 Months
SexALL
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Inclusion Criteria:
* Healthy infant born at ≥37 weeks' gestation
* Age 2 months (+ up to 14 days) at time of first study visit
* Parent/guardian or legally authorized representative has given informed consent for their child's participation.
Exclusion Criteria:
* Already received any routine 2-month immunizations
* Previous laboratory confirmed pneumococcal disease
* Previous receipt of any pneumococcal vaccine
* Confirmed or suspected immunodeficiency, including but not limited to:
* Congenital or acquired asplenia, or splenic dysfunction
* B-cell (humoral), T-cell mediated, complement, or phagocytic function deficiency
* HIV infection
* Hematopoietic stem cell transplant (recipient)
* Malignant neoplasms, including leukemia and lymphoma
* Nephrotic syndrome
* Solid organ or islet transplant (candidate or recipient)
* A family history of congenital or hereditary immunodeficiency
* Use of systemic immunosuppressive medication, including long-term corticosteroids, chemotherapy, radiation therapy, post-organ transplant therapy, intravenous immunoglobulin and/or specific monoclonal antibody therapy
* Bleeding disorder or thrombocytopenia, that contraindicates intramuscular (IM) injection and/or blood collection or taking any anti-platelet or anti-coagulant medications
* Any contraindication to vaccination as per the NACI Canadian Immunization Guide (https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html, accessed 16 September 2017). N…