Clinical trial NCT05934890: A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pneumococcal Disease, Invasive
Lead sponsor: Walvax Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 630
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active-controlled
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Infants must meet ALL the following inclusion criteria for enrollment in the study, at the time of the screening:

  1. Healthy infants based on medical history and clinical assessment.
  2. 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.
  3. Body weight at enrollment ≥3.5 kg.
  4. 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.
  5. 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.
  6. 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.

Exclusion Criteria:

* 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:

  1. Use of any investigational medicinal product prior to randomization or planned use of such a product during the period of study participation.
  2. History of S. pneumoniae infection as confirmed by medical enquiry or as confirmed by laboratory testing if available.
  3. 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.)
  4. 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).
  5. 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.
  6. History of anaphylactic shock.
  7. Any abnormal vital sign.
  8. Any moderate or severe acute illness.
  9. 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.)
  10. 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.
  11. Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
  12. 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).
  13. History of suspected primary immunodeficiency.
  14. History of meningitis, seizures or any neurological disorder.
  15. A family history of congenital or hereditary immunodeficiency.
  16. The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.
  17. 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.

Primary outcomes:
measure: Immunogenicity and non-inferiority as measured by serotype-specific IgG
timeFrame: 1 month after the booster dose
measure: Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
timeFrame: 1 month after the booster dose
Secondary outcomes:
measure: Solicited local and systemic adverse events after each dose
timeFrame: within 30 min and 7 days after each dose
measure: Unsolicited adverse events after each dose
timeFrame: within 30 days after each dose
measure: Serious adverse events throughout the study
timeFrame: from dose 1 until 6 months after booster dose
measure: Immune response to primary series as measured by serotype-specific IgG
timeFrame: 1 month after the 2nd dose
measure: Immune response to primary series as measured by serotype-specific IgG GMC
timeFrame: 1 month after the 2nd dose
measure: Functional antibody responses as measured by serotype-specific OPA titer
timeFrame: baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose
measure: Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)
timeFrame: baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose
measure: Immune persistence as measured by serotype-specific IgG
timeFrame: 12-15 months of age, before the booster dose
measure: Immune persistence as measured by serotype-specific IgG GMC
timeFrame: 12-15 months of age, before the booster dose
Other outcomes:
measure: Exploratory_Non-interference
timeFrame: 1 month after the 2nd dose
measure: Exploratory_Non-interference
timeFrame: 1 month after the 2nd dose
measure: Exploratory_Non-interference
timeFrame: 1 month after the 2nd dose with respect to baseline titers
measure: Exploratory_Non-interference
timeFrame: 1 month after the 2nd dose.
measure: Exploratory_Non-interference
timeFrame: 1 month after the 2nd dose.
measure: Exploratory_Non-interference
timeFrame: 1 month after the 2nd dose.
Locations:
city: Denpasar
country: Indonesia
facility: RSUP Prof. Dr. I.G.N.G Ngoerah
state: Bali
city: Jakarta Pusat
country: Indonesia
facility: Ilmu Kesehatan anak FKUI RSCM
state: Jakarta
Study officials:
References: