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RecruitingNCT06608199Updated Mar 24, 2025

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

A Phase 3 interventional study of pneumococcal disease prevention in Pneumococcal Vaccines and Pneumococcal Infections, sponsored by Beijing Minhai Biotechnology Co., Ltd. Recruiting at 3 sites in Indonesia. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
6 Weeks to 8 Weeks
Sex
All
01

Study 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).

Read the detailed description

A total of approximately 500 infants 6-8 weeks of age (WOA) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 250 participants in each group.The study group will receive study PCV13 vaccine and control group will receive Prevenar13® vaccine at 2, 4 and 12-15 months of age (MOA, as early as 6 weeks of age as per WHO recommendations for administration of PCV to infants). Hexavalent vaccine will be injected at 2, 3 and 4 months of age.

02

Conditions studied

  • Pneumococcal Vaccines
  • Pneumococcal Infections

Keywords

  • PCV13
  • Hexavalent Vaccine
  • Prevenar 13
  • Co-administration
03

Who can participate

Ages eligible
6 Weeks to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy infants based on medical history and clinical assessment.
  2. 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.
  3. *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.).
  4. *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.).
  5. 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.
  6. 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.
  7. 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.
  8. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. History of S. pneumoniae infection as confirmed by laboratory testing if available.
  3. 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).
  4. 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.
  5. History of anaphylactic shock.
  6. Any abnormal vital sign as judged by the investigator.
  7. *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.
  8. *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).
  9. 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.
  10. History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
  11. 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.
  12. *Administration of immunoglobulins and/or any blood products or anticipation of such administration within 28 days before vaccination and during the study period.
  13. 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).
  14. History of suspected primary immunodeficiency.
  15. History of meningitis, seizures or any neurological disorder.
  16. A family history of congenital or hereditary immunodeficiency.
  17. The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.
  18. 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.

Note: For items with an asterisk (*), if the participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.

04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    PCV13-DT/TT(Pneuminvac)

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

    Biological: pneumococcal disease prevention

  • Active comparator
    PCV13(Prenenar13)

    250 infants will be administered with Prenenar13

    Biological: pneumococcal disease prevention

Interventions

  • Biologicalpneumococcal disease prevention

    2P+1 programme of PCV13

05

What researchers measure

Primary outcomes

  1. Immugenocity

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

    Time frame: 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

  1. Safety

    1.To assess the solicited AEs (local and systemic) occurring 0-7 days after each dose of the investigational vaccine.

    Time frame: 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.

  2. Safety

    2. To assess the unsolicited AEs occurring 0-30 days after each dose of the investigational vaccine.

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

  3. Safety

    3. To assess SAE from 1st dose to 6 months after booster dose of the investigational vaccine.

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

  4. Immugenocity

    1. To evaluate the serotype-specific IgG responses 30 days after 2nd dose of the investigational vaccine. 2. To evaluate the serotype-specific Opsonophagocytic Activicity (OPA) 30 days after the 2nd dose, before the booster dose, and 30 days after the booster dose of the investigational vaccine in OPA subgroup. 3. To evaluate the immune responses induced by hexavalent vaccine 30 days after the 2nd dose of the investigational vaccine in different subsets.

    Time frame: 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

06

Study locations

1 of 3 sites recruiting
  • Universitas Padjadjaran Bandung
    Bandung, 40161, Indonesia
    • Dr. Eddy Fadlyana, dr., Sp.A(K)., Mkes, Doctor · Contact · edfadlyana@yahoo.com · +62 811-2320 - 259
    Not yet recruiting
  • Faculty of Medicine, padjadjaran University
    Bandung, Indonesia
    • Dr. Eddy Fadlyana, dr., Sp.A(K), M.Kes, Doctor · Contact · edfadlyana@yahoo.com · +62 811-2320 - 259
    Recruiting
  • Faculty of Medicine Udayana University
    Denpasar, 80114, Indonesia
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06608199
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Nov 1, 2024
Primary completion
Jun 1, 2025 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Mar 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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