13‑valent pneumococcal vaccine given to infants starting at 2 months

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 trial will test whether a new 13‑valent pneumococcal vaccine given at 2, 4, and 12–15 months produces strong immune responses and is safe in healthy infants starting at about 2 months of age.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 6 Weeks to 2 Months
• Sex: All
• Sponsor: CanSino Biologics Inc. (Industry-sponsored)
• Locations: 3 sites (Bangkok and 2 other locations)
• Trial ID: NCT07017777 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, observation‑blinded, active‑controlled, parallel‑group trial enrolling about 600 healthy infants in Thailand who begin vaccination at 2 months of age and follow a 2+1 schedule (2, 4, and 12–15 months). Participants are randomized 1:1 to receive either the experimental PCV13i or the licensed control vaccine (Prevnar 13), with a nested subcohort of approximately 200 infants (100 per arm) undergoing additional immunogenicity testing after the primary series. Safety is monitored by collecting solicited adverse events for 7 days and unsolicited adverse events for 30 days after each vaccination. Immunogenicity is measured at baseline and after the booster dose for all participants, with the subcohort also assessed after the primary series.

Who should consider this trial

Good fit: Healthy infants aged about 6 weeks to 2 months (42–90 days) with stable clinical status whose parent or guardian can consent and commit to study visits and follow‑up are eligible.

Not a fit: Infants born before 35 weeks' gestation, those who have already received a pneumococcal vaccine, or those with significant medical conditions likely will not benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could increase protection against pneumococcal disease in early childhood by producing strong antibody responses with an acceptable safety profile.

How similar studies have performed: Licensed 13‑valent pneumococcal conjugate vaccines like Prevnar 13 have a well‑established record of effectiveness, so the overall approach is proven though this specific formulation is being tested in Phase 3.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria for the first dose:

* 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
* 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.

Where this trial is running

Bangkok and 2 other locations

• Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
• King Chulalongkorn Memorial Hospital — Bangkok, Thailand (Recruiting)
• Phramongkutklao Hospital — Bangkok, Thailand (Recruiting)

Study contacts

• Principal investigator: Supattra Rungmaitree, Doctor of Medicine — Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
• Study coordinator: Meixu Yan

Conditions Pneumococcal Infections; Streptococcal Infections; Bacterial Infections; PCV13i; 13 valent Pneumococcal conjugate vaccine; Pneumococcal infections; 2 months of age; Safety