CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study
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ClinicalTrials.gov Identifier: NCT03384589 |
Recruitment Status :
Active, not recruiting
First Posted : December 27, 2017
Last Update Posted : May 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Invasive Pneumococcal Disease, Protection Against Streptococcus Pneumoniae Infection | Biological: PCV13 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 248 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Group 1: 3 doses of PCV13 (2, 4, 12 months), 2+1 Group 2: 2 doses of PCV13 (2, 12 months), 1+1 |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Controlled Trial to Compare a 1-dose vs. 2-dose Priming Schedule of 13-valent Pneumococcal Conjugate Vaccine in Canadian Infants; a Canadian Immunization Research Network (CIRN) Study |
Actual Study Start Date : | August 23, 2018 |
Actual Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Group 1: 3 doses of PCV13
PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age
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Biological: PCV13
Vaccine against pneumococcal disease
Other Name: Prevnar 13 |
Experimental: Group 2: 2 doses of PCV13
PCV13, 0.5ml intramuscular at 2 and 12 months of age
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Biological: PCV13
Vaccine against pneumococcal disease
Other Name: Prevnar 13 |
- Immunogenicity of PCV13 post-booster [ Time Frame: 13 months of age ]Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose
- Immunogenicity of PCV13 post-priming [ Time Frame: 5 months of age ]Serotype-specific pneumococcal IgG concentration post-priming dose(s)
- Proportion of protected infants post-booster [ Time Frame: 13 months of age ]Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-booster dose
- Proportion of protected infants post-priming [ Time Frame: 5 months of age ]Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-priming dose(s)
- Incidence of adverse events following PCV13 [ Time Frame: 2, 4 and 12 months of age ]Adverse events following immunization after doses of PCV13
- Storage of fecal samples for analysis of the influence of the infant microbiome on vaccine responses [ Time Frame: 2, 4, 6 and 12 months of age ]Collection of fecal samples at time of vaccination
- Immunogenicity of PCV13 after maternal pertussis immunization [ Time Frame: 5 and 13 months ]Comparison of primary and secondary endpoints in infants born to mothers who received pertussis immunization in pregnancy vs. those that did not
- Rate of nasopharyngeal colonization after vaccination with S. pneumoniae [ Time Frame: 13 months ]Comparison of nasopharyngeal colonization rate with S. pneumoniae in Group 1 vs. Group 2

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Ages Eligible for Study: | 2 Months to 2 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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
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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). Note these factors will be considered an exclusion if known at the time of trial enrollment, but specific screening and/or testing for these conditions will not be part of the trial):
- Anaphylaxis to any vaccine or vaccine component being given during the trial, including PCV13 and other routine vaccines
- Any other previous adverse event which in the opinion of the Investigator is a contraindication to any vaccine being given during the trial
- Congenital malformation of the gastrointestinal tract or previous intussusception (rotavirus vaccine contraindicated)
- Active, untreated tuberculosis (MMR, varicella, MMRV contraindicated)
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Additional factors resulting in increased risk of pneumococcal disease as per the National Advisory Committee on Immunization (NACI) Canadian Immunization Guide (16 September 2017)
- Chronic cerebrospinal fluid (CSF) leak
- Chronic neurologic condition that may impair clearance of oral secretions
- Cochlear implants, including children who are due to receive implants
- Chronic heart disease
- Diabetes mellitus
- Chronic kidney disease
- Chronic liver disease, including hepatic cirrhosis due to any cause
- Chronic lung disease
- Sickle cell disease or other hemoglobinopathy
- Mother received pneumococcal vaccine during pregnancy
- Mother using systemic immunosuppressive medication during pregnancy, including intravenous immunoglobulin and/or specific monoclonal antibody therapy
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Temporary exclusion criteria:
- If an infant has a temperature ≥ 38°C, then vaccination (and blood and fecal sampling if due to occur at the same visit) will be postponed until resolution of fever.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384589
Canada, British Columbia | |
Vaccine Evaluation Center (University of BC at Children's Hospital) | |
Vancouver, British Columbia, Canada, V5Z 4H4 |
Principal Investigator: | Manish Sadarangani, MD | UBC |
Responsible Party: | Manish Sadarangani, Principle Investigator, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT03384589 |
Other Study ID Numbers: |
H17-02645 CIRN23/CT16 ( Other Identifier: UBC ) |
First Posted: | December 27, 2017 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Pneumonia, Pneumococcal Pneumococcal Infections Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Streptococcal Infections |
Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Pneumonia, Bacterial Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |