Pneumococcal InfectionsPhase 3NCT07017777
A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
A Phase 3 study testing PCV13i and Prevnar 13 in people with Pneumococcal Infections and Streptococcal Infections, run by CanSino Biologics Inc. at 3 sites in Thailand.
Trial summary
This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and… Read more about this study
- Who is it for?
- Ages 6 weeks to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
- What is being tested?
- PCV13i and Prevnar 13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesThailand
- Study dates
- 14 Nov 2025to 15 May 2028
- Phase
- Phase 3
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 6 weeks to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day they turn 6 weeks of age.
- Infant's parent or legal guardian must be able and willing to provide informed consent for the infant's participation in the study.
- Participants and their parent or legal guardian must demonstrate the ability to comply with all trial procedures and be available for the entire follow-up duration.
- The infant's parent or legal guardian must have an easily identifiable and stable place of residence within the study area, be available for the duration of trial participation, and have access to a reliable means of telephone contact for communication with the study team.
Who cannot join
- Infants born at <35 weeks of gestation.
- Infants who have previously received any pneumococcal vaccine.
- Infants currently participating in or who have recently participated in another interventional clinical trial.
- Infants with an axillary temperature of ≥37.8°C at the time of enrollment (the participant must be deferred until recovery. The visit may be rescheduled when this criterion is met.)
- Infants with any congenital abnormalities, chronic medical conditions, or genetic disorders, severe malnutrition, inherited disease and others, that in the investigator's judgment, may interfere with the study outcomes.
- History of anaphylactic shock
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- History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the experimental and control vaccine
- History of epilepsy and convulsions.
- Have received immunosuppressive treatment, cytotoxic treatment, systemic steroid treatment for more than 2 weeks, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis).
- Received or planned to receive blood/plasma products or immunoglobulins throughout the study period or prior to study vaccination.
- History of coagulation disorders or blood conditions that could cause anemia or excess bleeding as judged by the investigator.
- Infants with known or suspected immunodeficiency, as determined by medical history and/or physical examination.
- Administration of other vaccines within 7 days prior to enrollment.
- Any history or current evidence of a condition or therapy that could confound study results, interfere with participation, or is not in the best interest of the participant, as judged by the investigator.
- The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.
- Any other condition or situation that, in the investigator's judgment, might interfere with the study or pose additional risks to the participant.
- Individual termination criteria for subsequent doses:
- Severe allergic reaction after the previous vaccination.
- Serious adverse events caused by the previous vaccination that is not suitable for subsequent vaccination(s) as judged by the investigator.
- Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator.
- Other reasons for exclusion considered by the investigator.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok
King Chulalongkorn Memorial Hospital
Bangkok
Phramongkutklao Hospital
Bangkok
About this study
Official title: A Phase III, Observer-blind, Randomized Controlled Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.
- Being tested
- PCV13i, Prevnar 13
- Keywords
- PCV13i, 13 valent Pneumococcal conjugate vaccine, Pneumococcal infections, 2 months of age, Safety, Immunogenicity
- Medical subject headings
- Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13iBiological
3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
Prevnar 13Biological
3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
| Study group | Role | What they receive |
|---|---|---|
| 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/TT) (PCV13i) | Experimental | Intramuscular Injection, 0.5ml Receives: Biological: PCV13i |
| Pneumococcal 13-valent Conjugate Vaccine (Prevnar 13) | Active comparator | Intramuscular Injection, 0.5ml Receives: Biological: Prevnar 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL
Measured: 30 days after the booster dose
Incidence of solicited local and systemic adverse events (AEs)
Measured: Within 7 days after each dose of vaccination
Secondary outcomes (7)
Incidence of unsolicited adverse events
Measured: Within 30 days after each dose of vaccination
The number of serious adverse events (SAEs)
Measured: Through study completion, an average of 16-19 months
The geometric mean concentration (GMC) of Serotype-specific IgG in all participants
Measured: Before vaccination and 30 days after the booster dose
Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort A participants
Measured: 30 days after the primary series
Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort B participants
Measured: Before the booster dose
The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort A participants
Measured: 30 days after the primary series
The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort B participants
Measured: Before the booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start14 Nov 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Supattra Rungmaitree, Doctor of Medicine, Principal investigator, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017777
- Sponsor's protocol ID
- CTP-PCV-002
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No