A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine

NCT06608199 | Recruiting Phase 3

• 1 other identifier: S20210036-5
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent 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-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).

Conditions

Pneumococcal Vaccines; Pneumococcal Infections

Keywords

PCV13; Hexavalent Vaccine; Prevenar 13; Co-administration

Outcome Measures

Primary Outcomes (1)

• Immugenocity

  1\. To evaluate the serotype-specific IgG responses 30 days after booster dose of the investigational vaccine.

  1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after the booster dose of the investigational vaccine. 2. GMC ratio of serotype-specific IgG responses 30 days after the booster dose of the investigat

Secondary Outcomes (4)

• Safety

  1.Incidence, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of the investigational vaccine in all participants.

• Safety

  2. Incidence, severity, and causality of unsolicited AEs within 30 days after each dose of the investigational vaccine in all participants.

• Safety

  3. Incidence, severity, and causality of SAEs from 1st dose to 6 months after booster dose of the investigational vaccine.

• Immugenocity

  1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after 2nd dose of the investigational vaccine. 2. GMC of serotype-specific IgG responses 30 days after 2nd dose of the investigational vaccine. 3. Pe

Study Arms (2)

PCV13-DT/TT(Pneuminvac)

EXPERIMENTAL

250 infants will be administered with Minhai's PCV13-DT/TT(Pneuminvac)

Biological: pneumococcal disease prevention

PCV13(Prenenar13)

ACTIVE COMPARATOR

250 infants will be administered with Prenenar13

Biological: pneumococcal disease prevention

Interventions

pneumococcal disease prevention BIOLOGICAL

2P+1 programme of PCV13

PCV13(Prenenar13); PCV13-DT/TT(Pneuminvac)

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants based on medical history and clinical assessment.
• Infants 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 ≥3.0 kg (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).
• \*On the day of vaccination and within 3 days prior to 1st dose of vaccination, axillary temperatures \<37.5°C/99.1°F (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).
• Infant's parent(s) or legal guardian 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 must be willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• The infant's mother must provide related medical certificate(s) for the negative results for HIV, HBV and syphilis infection within 1 year prior to screening.
• Infant's parent(s) or legal guardian must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have a means of telephone contact.
• Note: For items with an asterisk (\*), If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.

You may not qualify if:

• Use of any investigational product other than that used in the study prior to randomization or planned use of such a product during the period of study participation.
• History of S. pneumoniae infection as confirmed by laboratory testing if available.
• 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 investigational vaccine. And/or all components of the hexavalent vaccine.
• History of anaphylactic shock.
• Any abnormal vital sign as judged by the investigator.
• \*Participant experiences acute diseases or acute exacerbation of chronic diseases or uses antipyretic, analgesic and anti-allergic drugs (such as paracetamol, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days before vaccination.
• \*History of administration of attenuated vaccines within 14 days (\<14 days) and inactivated vaccines within 7 days (\<7 days) prior to the 1st dose of investigational vaccine (If the participant\[s\] does not meet the criteria, the visit may be rescheduled when the criteria are met).
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given before 2 months of life according to the national recommendations.
• History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
• 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 ≥10 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 within 28 days before vaccination and during the study period.
• History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factors deficiency, severe anemia at birth).
• History of suspected primary immunodeficiency.
• History of meningitis, seizures or any neurological disorder.

Sponsors & Collaborators

• Beijing Minhai Biotechnology Co., Ltd: lead

Study Sites (3)

Faculty of Medicine Udayana University

Denpasar, Bali, 80114, Indonesia

NOT YET RECRUITING

Universitas Padjadjaran Bandung

Bandung, Bandung, 40161, Indonesia

NOT YET RECRUITING

Faculty of Medicine, padjadjaran University

Bandung, Bandung, Indonesia

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)