A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfi… (NCT05934890) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13
Indonesia630 participantsStarted 2023-11-23
Plain-language 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.
Who can participate
Age range6 Weeks – 8 Weeks
SexALL
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Inclusion criteria
✓. 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
✕. 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).
What they're measuring
1
Immunogenicity and non-inferiority as measured by serotype-specific IgG
Timeframe: 1 month after the booster dose
2
Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
✕. 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.