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

Primary Purpose

Pneumococcal Disease, Invasive

Status
Not yet recruiting
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Walvax PCV13-TT
Pfizer PCV13
Sponsored by
Walvax Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease, Invasive

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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: 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. 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.

Sites / Locations

  • Departemen Ilmu Kesehatan Anak FK Unud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walvax PCV13-TT

Pfizer PCV13

Arm Description

Primary 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.

Primary 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.

Outcomes

Primary Outcome Measures

Immunogenicity and non-inferiority as measured by serotype-specific IgG
Percentage of infants with serotype-specific IgG concentrations ≥0.35 μg/mL
Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
Serotype-specific IgG GMCs

Secondary Outcome Measures

Solicited local and systemic adverse events after each dose
Frequency and severity of solicited local and systemic adverse events (AEs)
Unsolicited adverse events after each dose
Frequency and severity of unsolicited AEs
Serious adverse events throughout the study
Frequency of serious AEs (SAEs)
Immune response to primary series as measured by serotype-specific IgG
Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL
Immune response to primary series as measured by serotype-specific IgG GMC
Serotype-specific IgG GMCs
Functional antibody responses as measured by serotype-specific OPA titer
Percentage of infants with serotype-specific OPA titer ≥1:8
Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)
Serotype-specific OPA geometric mean titers (GMTs)
Immune persistence as measured by serotype-specific IgG
Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL
Immune persistence as measured by serotype-specific IgG GMC
Serotype-specific IgG GMCs

Full Information

First Posted
June 28, 2023
Last Updated
June 28, 2023
Sponsor
Walvax Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05934890
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walvax Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypothesis of non-inferiority test for seropositive rate and GMC in each serotype
Detailed Description
H0: the immune responses elicited by PCV13-TT are inferior to those elicited by PCV13 HA: the immune responses elicited by PCV13-TT are non-inferior to those elicited by PCV13. Non-inferiority of the immune responses elicited by PCV13-TT will be declared if both of the following criteria are met: (1) the lower limit of the 2-sided 95% CI of the difference (PCV13-TT-PCV13) in proportions of responders who achieving the threshold of 0.35 µg/ml is >-10%; and (2) the lower limit of the 2-sided 95% CI of the GMC ratio (PCV13-TT/PCV13) is >0.5. Thus, the familywise type I error will not be inflated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease, Invasive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Active-controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walvax PCV13-TT
Arm Type
Experimental
Arm Description
Primary 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.
Arm Title
Pfizer PCV13
Arm Type
Active Comparator
Arm Description
Primary 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.
Intervention Type
Biological
Intervention Name(s)
Walvax PCV13-TT
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Pfizer PCV13
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunogenicity and non-inferiority as measured by serotype-specific IgG
Description
Percentage of infants with serotype-specific IgG concentrations ≥0.35 μg/mL
Time Frame
1 month after the booster dose
Title
Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
Description
Serotype-specific IgG GMCs
Time Frame
1 month after the booster dose
Secondary Outcome Measure Information:
Title
Solicited local and systemic adverse events after each dose
Description
Frequency and severity of solicited local and systemic adverse events (AEs)
Time Frame
within 30 min and 7 days after each dose
Title
Unsolicited adverse events after each dose
Description
Frequency and severity of unsolicited AEs
Time Frame
within 30 days after each dose
Title
Serious adverse events throughout the study
Description
Frequency of serious AEs (SAEs)
Time Frame
from dose 1 until 6 months after booster dose
Title
Immune response to primary series as measured by serotype-specific IgG
Description
Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL
Time Frame
1 month after the 2nd dose
Title
Immune response to primary series as measured by serotype-specific IgG GMC
Description
Serotype-specific IgG GMCs
Time Frame
1 month after the 2nd dose
Title
Functional antibody responses as measured by serotype-specific OPA titer
Description
Percentage of infants with serotype-specific OPA titer ≥1:8
Time Frame
baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose
Title
Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)
Description
Serotype-specific OPA geometric mean titers (GMTs)
Time Frame
baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose
Title
Immune persistence as measured by serotype-specific IgG
Description
Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL
Time Frame
12-15 months of age, before the booster dose
Title
Immune persistence as measured by serotype-specific IgG GMC
Description
Serotype-specific IgG GMCs
Time Frame
12-15 months of age, before the booster dose
Other Pre-specified Outcome Measures:
Title
Exploratory_Non-interference
Description
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥0.1 IU/mL
Time Frame
1 month after the 2nd dose
Title
Exploratory_Non-interference
Description
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥0.1 IU/mL
Time Frame
1 month after the 2nd dose
Title
Exploratory_Non-interference
Description
Proportion of subjects with 4-fold increase in anti-pertussis IgG concentration
Time Frame
1 month after the 2nd dose with respect to baseline titers
Title
Exploratory_Non-interference
Description
Percentage of infants with anti Haemophilus influenzae type b (PRP) IgG concentration ≥0.15 µg/mL
Time Frame
1 month after the 2nd dose.
Title
Exploratory_Non-interference
Description
Percentage of infants with anti Hepatitis B surface antigen (hBsAg) IgG oncentrations ≥10 mIU/mL
Time Frame
1 month after the 2nd dose.
Title
Exploratory_Non-interference
Description
Percentage of infants with anti poliovirus types 1, 2 and 3 neutralizing antibody titers ≥1:8 measured
Time Frame
1 month after the 2nd dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Shi
Phone
+8619912789963
Email
lei.shi@walvax.com
Facility Information:
Facility Name
Departemen Ilmu Kesehatan Anak FK Unud
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Gusti Ayu Trisna Windiani,SpA(K), Dr.
First Name & Middle Initial & Last Name & Degree
IGA Ngurah Sugitha Adnyana,SpA(K), Doctor
First Name & Middle Initial & Last Name & Degree
Anak Agung Sagung Sawitri,MPH, Dr.
First Name & Middle Initial & Last Name & Degree
Ni Luh Sukma Pratiwi Murti,M.Biomed,Sp.A, Dr.
First Name & Middle Initial & Last Name & Degree
I Made Darma Yuda,M.Biomed,Sp.A, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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