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

Walvax Biotechnology Co., Ltd.2 sites in 1 country630 target enrollmentNovember 23, 2023

ConditionsPneumococcal Disease, Invasive

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pneumococcal Disease, Invasive
Sponsor: Walvax Biotechnology Co., Ltd.
Enrollment: 630
Locations: 2
Primary Endpoint: Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 23, 2023

End Date

February 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Walvax Biotechnology Co., Ltd.

Responsible Party

Sponsor

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.)

Outcomes

Primary Outcomes

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

Time Frame: 1 month after the booster dose

Serotype-specific IgG GMCs

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

Time Frame: 1 month after the booster dose

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

Secondary Outcomes

Solicited local and systemic adverse events after each dose(within 30 min and 7 days after each dose)
Immune response to primary series as measured by serotype-specific IgG(1 month after the 2nd dose)
Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)(baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose)
Immune persistence as measured by serotype-specific IgG(12-15 months of age, before the booster dose)
Immune persistence as measured by serotype-specific IgG GMC(12-15 months of age, before the booster dose)
Serious adverse events throughout the study(from dose 1 until 6 months after booster dose)
Immune response to primary series as measured by serotype-specific IgG GMC(1 month after the 2nd dose)
Unsolicited adverse events after each dose(within 30 days after each dose)
Functional antibody responses as measured by serotype-specific OPA titer(baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose)