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Pneumococcal Disease, InvasivePhase 3NCT05934890

A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13

A Phase 3 study testing Walvax PCV13-TT and Pfizer PCV13 in people with Pneumococcal Disease, Invasive, run by Walvax Biotechnology Co., Ltd. at 2 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13) when co-administered with local EPI Vaccines at 2, 4, and 12-15 months of age, to healthy… Read more about this study

Who is it for?
Ages 6 to 8 weeksHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease, Invasive
What is being tested?
Walvax PCV13-TT and Pfizer PCV13
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
2 sitesIndonesia
Study dates
23 Nov 2023to Feb 2026
Phase
Phase 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 6 to 8 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants must meet ALL the following inclusion criteria for enrollment in the study, at the time of the screening:
  • Healthy infants based on medical history and clinical assessment.
  • Age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included.
  • Body weight at enrollment ≥3.5 kg.
  • Infant's parent(s) or legal guardian(s) must be able and willing to provide voluntary written/thumb-printed informed consent for the infant to participate in the study.
  • Infant's parent(s) or legal guardian(s) must be able to comprehend and comply with study requirements and procedures and must be willing and able to return or make themselves available for all scheduled follow-up visits.
  • Infant's parents must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have means of telephone contact.

Who cannot join

  • The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
  • Use of any investigational medicinal product prior to randomization or planned use of such a product during the period of study participation.
  • History of S. pneumoniae infection as confirmed by medical enquiry or as confirmed by laboratory testing if available.
  • Participant has fever (axillary temperature ≥ 37.5℃) within 24 hours prior to the 1st dose of vaccination; (If the subject does not meet the criteria, the visit may be rescheduled when the criteria are met.)
  • The infant who are children in care, preterm and low-birth-weight(Preterm infants have a gestational age below 37 weeks at birth and low-birth-weight infants have a birth weight below 2.5 kg).
  • History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the 2 study vaccines. This includes all components of the EPI vaccines.
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  • History of anaphylactic shock.
  • Any abnormal vital sign.
  • Any moderate or severe acute illness.
  • History of administration of a non-study vaccine within 30 days prior to administration of study vaccine, other than EPI vaccinations (Note: EPI vaccines other than that stipulated in the study must be given at least 14 days prior to the investigational vaccine.)
  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for 14 days at a dose of 20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids within indicated dosage are permitted.
  • Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
  • History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth).
  • History of suspected primary immunodeficiency.
  • History of meningitis, seizures or any neurological disorder.
  • A family history of congenital or hereditary immunodeficiency.
  • The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.
  • Any medical or social condition that in the opinion of the investigator may compromise the well-being of the study participant, interfere with the study objectives, pose a risk to the study participant, or prevent the study participant from completing the study follow-up.

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • RSUP Prof. Dr. I.G.N.G Ngoerah

    Denpasar, Bali, 80114

  • Ilmu Kesehatan anak FKUI RSCM

    Jakarta Pusat, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

Official title: A Phase 3, Randomized, Blinded, Active-controlled Study to Evaluate the Immunogenicity and Safety of Walvax's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) as Compared to Pfizer's 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Co-administered With EPI Vaccines at 2, 4, and 12-15 Months of Age, to Healthy Infants in Indonesia

The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13) when co-administered with local EPI Vaccines at 2, 4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-TT as compared to PCV13 one month after the booster dose.

Being tested
Walvax PCV13-TT, Pfizer 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.

  • Walvax PCV13-TTBiological

    PCV13-TT is supplied as 0.5 mL prefill syringe (PFS), with 0.5 mL suspension for intramuscular injection. After shaking, the vaccine is a homogenous, white suspension. Each dose (0.5 mL) of PCV13-TT contains pneumococcal polysaccharide serotypes 1, 3 4, 5, 6A 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F which are conjugated to TT carrier protein individually.

    The vaccine is formulated in phosphate-buffered saline containing 4.25 mg/dose sodium chloride (NaCl), 44.35 μg/dose sodium dihydrogen phosphate (NaH2PO4), 19.0 μg/dose disodium hydrogen phosphate (Na2HPO4), and contains 0.5 mg/dose of aluminum phosphate as an adjuvant; no preservatives added.

  • Pfizer PCV13Biological

    PCV13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes. Each 0.5 mL dose of PCV13 is formulated to contain approximately 2.2 μg of each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F polysaccharides, 4.4 μg of 6B polysaccharides, 34 μg 26 CRM197 carrier protein, 100 μg polysorbate 80, 295 μg succinate buffer and 125 μg aluminum as aluminum phosphate adjuvant.

Study groups in NCT05934890
Study groupRoleWhat they receive
Walvax PCV13-TTExperimentalPrimary Vaccination: A total of approximately 300 infants 6-8 weeks of age will be enrolled and assigned randomly to receive at 2, 4, and 12-15 months of age 1 dose of PCV13-TT. Standard EPI vaccines will be administered concomitantly. Booster Vaccination: At 12-15 months of age (8 to 11 months after the 2nd dose of the primary series), infants will receive a booster dose of PCV13-TT.
Receives: Biological: Walvax PCV13-TT
Pfizer PCV13Active comparatorPrimary Vaccination: A total of approximately 300 infants 6-8 weeks of age will be enrolled and assigned randomly to receive at 2, 4, and 12-15 months of age 1 dose of PCV13. Standard EPI vaccines will be administered concomitantly. Booster Vaccination: At 12-15 months of age (8 to 11 months after the 2nd dose of the primary series), infants will receive a booster dose of PCV13.
Receives: Biological: Pfizer PCV13

What is being measured

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

  1. Immunogenicity and non-inferiority as measured by serotype-specific IgG

    Percentage of infants with serotype-specific IgG concentrations ≥0.35 μg/mL

    Measured: 1 month after the booster dose

  2. Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC

    Serotype-specific IgG GMCs

    Measured: 1 month after the booster dose

Secondary outcomes (9)

  1. Solicited local and systemic adverse events after each dose

    Frequency and severity of solicited local and systemic adverse events (AEs)

    Measured: within 30 min and 7 days after each dose

  2. Unsolicited adverse events after each dose

    Frequency and severity of unsolicited AEs

    Measured: within 30 days after each dose

  3. Serious adverse events throughout the study

    Frequency of serious AEs (SAEs)

    Measured: from dose 1 until 6 months after booster dose

  4. Immune response to primary series as measured by serotype-specific IgG

    Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL

    Measured: 1 month after the 2nd dose

  5. Immune response to primary series as measured by serotype-specific IgG GMC

    Serotype-specific IgG GMCs

    Measured: 1 month after the 2nd dose

  6. Functional antibody responses as measured by serotype-specific OPA titer

    Percentage of infants with serotype-specific OPA titer ≥1:8

    Measured: baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose

  7. Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)

    Serotype-specific OPA geometric mean titers (GMTs)

    Measured: baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose

  8. Immune persistence as measured by serotype-specific IgG

    Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL

    Measured: 12-15 months of age, before the booster dose

  9. Immune persistence as measured by serotype-specific IgG GMC

    Serotype-specific IgG GMCs

    Measured: 12-15 months of age, 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 posted7 Jul 2023
  2. Study start23 Nov 2023
  3. Primary completionMar 2025 (estimated)
  4. Study completionFeb 2026 (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
Model description
Active-controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934890
Sponsor's protocol ID
PCV13-004
Status last verified
Jul 2024
First submitted
28 Jun 2023
Last updated
3 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Walvax PCV13-TT and Pfizer PCV13 in people with Pneumococcal Disease, Invasive, run by Walvax Biotechnology Co., Ltd. at 2 sites in Indonesia.

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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. 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?

Results are not available in the source record.

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 and non-inferiority as measured by serotype-specific IgG (time frame: 1 month 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 NCT05934890.

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 3 Jul 2024.

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