Invasive Pneumococcal Disease, Protection AgainstPhase 2/3NCT03384589
CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study
A Phase 2/3 study testing PCV13 in people with Invasive Pneumococcal Disease, Protection Against and Streptococcus Pneumoniae Infection, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Invasive Pneumococcal Disease, Protection Against, Streptococcus Pneumoniae Infection
- What is being tested?
- PCV13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2018to 31 Mar 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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). 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)
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vaccine Evaluation Center (University of BC at Children's Hospital)
Vancouver, British Columbia, V5Z 4H4
About this study
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
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.
- Being tested
- PCV13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13Biological
Also called Prevnar 13
Vaccine against pneumococcal disease
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 3 doses of PCV13 | Active comparator | PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age Receives: Biological: PCV13 |
| Group 2: 2 doses of PCV13 | Experimental | PCV13, 0.5ml intramuscular at 2 and 12 months of age Receives: Biological: PCV13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of PCV13 post-booster
Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose
Measured: 13 months of age
Secondary outcomes (4)
Immunogenicity of PCV13 post-priming
Serotype-specific pneumococcal IgG concentration post-priming dose(s)
Measured: 5 months of age
Proportion of protected infants post-booster
Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-booster dose
Measured: 13 months of age
Proportion of protected infants post-priming
Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-priming dose(s)
Measured: 5 months of age
Incidence of adverse events following PCV13
Adverse events following immunization after doses of PCV13
Measured: 2, 4 and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start23 Aug 2018
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Pneumococcal Disease, Protection AgainstStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Immunization Research Network, Alberta Children's Hospital, Université de Montréal, IWK Health Centre, University of Calgary, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Manish Sadarangani, University of British Columbia
- Investigators
- Manish Sadarangani, MD, Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384589
- Sponsor's protocol ID
- H17-02645
- Other IDs
- CIRN23/CT16
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2017
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03384589
- Acronym / sponsor ID
- H17-02645
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Immunization Research Network, Alberta Children's Hospital, Université de Montréal, IWK Health Centre, University of Calgary, Canadian Institutes of Health Research (CIHR)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1: 3 doses of PCV13 | Active comparator | Biological: PCV13PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age |
| Group 2: 2 doses of PCV13 | Experimental | Biological: PCV13PCV13, 0.5ml intramuscular at 2 and 12 months of age |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (34 listed)
- 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:
- A family history of congenital or hereditary immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV13Also: Prevnar 13Vaccine against pneumococcal disease | Biological | Group 1: 3 doses of PCV13, Group 2: 2 doses of PCV13 |
Primary outcome
Immunogenicity of PCV13 post-booster
Time frame: 13 months of age
Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose
4 secondary outcomes
Immunogenicity of PCV13 post-priming
Time frame: 5 months of age
Proportion of protected infants post-booster
Time frame: 13 months of age
Proportion of protected infants post-priming
Time frame: 5 months of age
Incidence of adverse events following PCV13
Time frame: 2, 4 and 12 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Sadarangani, MD principal investigator
UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PCV13 in people with Invasive Pneumococcal Disease, Protection Against and Streptococcus Pneumoniae Infection, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of PCV13 post-booster (time frame: 13 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.