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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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
Are there results?
Not yet: the study is under way

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
Show all 21Show fewer
  • 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

Other trials in Thailand

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 groups in NCT07017777
Study groupRoleWhat they receive
13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/TT) (PCV13i)ExperimentalIntramuscular Injection, 0.5ml
Receives: Biological: PCV13i
Pneumococcal 13-valent Conjugate Vaccine (Prevnar 13)Active comparatorIntramuscular Injection, 0.5ml
Receives: Biological: Prevnar 13

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days after the booster dose

  2. Incidence of solicited local and systemic adverse events (AEs)

    Measured: Within 7 days after each dose of vaccination

Secondary outcomes (7)

  1. Incidence of unsolicited adverse events

    Measured: Within 30 days after each dose of vaccination

  2. The number of serious adverse events (SAEs)

    Measured: Through study completion, an average of 16-19 months

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

    Measured: Before vaccination and 30 days after the booster dose

  4. 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

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

    Measured: Before the booster dose

  6. The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort A participants

    Measured: 30 days after the primary series

  7. 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.

  1. First posted12 Jun 2025
  2. Study start14 Nov 2025
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 4 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL (time frame: 30 days after the booster dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07017777.

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 5 Aug 2026.

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