CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study

NCT03384589 | Completed Phase 2 FDA Drug

• 2 other identifiers: H17-02645CIRN23/CT16
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Pneumococcal Disease, Protection Against; Streptococcus Pneumoniae Infection

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of PCV13 post-booster

  Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose

  13 months of age

Secondary Outcomes (4)

• Immunogenicity of PCV13 post-priming

  5 months of age

• Proportion of protected infants post-booster

  13 months of age

• Proportion of protected infants post-priming

  5 months of age

• Incidence of adverse events following PCV13

  2, 4 and 12 months of age

Other Outcomes (3)

• Storage of fecal samples for analysis of the influence of the infant microbiome on vaccine responses

  2, 4, 6 and 12 months of age

• Immunogenicity of PCV13 after maternal pertussis immunization

  5 and 13 months

• Rate of nasopharyngeal colonization after vaccination with S. pneumoniae

  13 months

Study Arms (2)

Group 1: 3 doses of PCV13

ACTIVE COMPARATOR

PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age

Biological: PCV13

Group 2: 2 doses of PCV13

EXPERIMENTAL

PCV13, 0.5ml intramuscular at 2 and 12 months of age

Biological: PCV13

Interventions

PCV13 BIOLOGICAL

Vaccine against pneumococcal disease

Also known as: Prevnar 13

Group 1: 3 doses of PCV13; Group 2: 2 doses of PCV13

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Anaphylaxis to any vaccine or vaccine component being given during the trial, including PCV13 and other routine vaccines

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Immunization Research Network: collaborator
• Alberta Children's Hospital: collaborator
• Université de Montréal: collaborator
• IWK Health Centre: collaborator
• University of Calgary: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Vaccine Evaluation Center (University of BC at Children's Hospital)

Vancouver, British Columbia, V5Z 4H4, Canada

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Manish Sadarangani, MD

  UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Group 1: 3 doses of PCV13 (2, 4, 12 months), 2+1 Group 2: 2 doses of PCV13 (2, 12 months), 1+1

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 27, 2017
• Study Start: August 23, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

CA (1)