A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)

NCT07017777 | Recruiting Phase 3

• 1 other identifier: CTP-PCV-002
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Keywords

PCV13i; 13 valent Pneumococcal conjugate vaccine; Pneumococcal infections; 2 months of age; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL

  30 days after the booster dose

• Incidence of solicited local and systemic adverse events (AEs)

  Within 7 days after each dose of vaccination

Secondary Outcomes (7)

• Incidence of unsolicited adverse events

  Within 30 days after each dose of vaccination

• The number of serious adverse events (SAEs)

  Through study completion, an average of 16-19 months

• The geometric mean concentration (GMC) of Serotype-specific IgG in all participants

  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

  30 days after the primary series

• Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort B participants

  Before the booster dose

Study Arms (2)

13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/TT) (PCV13i)

EXPERIMENTAL

Intramuscular Injection, 0.5ml

Biological: PCV13i

Pneumococcal 13-valent Conjugate Vaccine (Prevnar 13)

ACTIVE COMPARATOR

Intramuscular Injection, 0.5ml

Biological: Prevnar 13

Interventions

PCV13i BIOLOGICAL

3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)

13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/TT) (PCV13i)

Prevnar 13 BIOLOGICAL

3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)

Pneumococcal 13-valent Conjugate Vaccine (Prevnar 13)

Eligibility Criteria

• Age: 6 Weeks - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (3)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

RECRUITING

Phramongkutklao Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Supattra Rungmaitree, Doctor of Medicine

  Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meixu Yan

CONTACT

022-58213600-6051; meixu.yan@cansinotech.com

Lina Wang

CONTACT

022-58213600-6051; lina.wang@cansinotech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-05

Locations

TH (3)