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Pneumococcal VaccinesPhase 3NCT06608199

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 study testing pneumococcal disease prevention in people with Pneumococcal Vaccines and Pneumococcal Infections, run by Beijing Minhai Biotechnology Co., Ltd at 3 sites in Indonesia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 6 to 8 weeksHealthy volunteers can take part
What is being tested?
pneumococcal disease prevention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
3 sitesIndonesia
Study dates
1 Nov 2024to 1 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • *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.
  • 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.
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Indonesia3 sites, 3 recruiting

  • Universitas Padjadjaran Bandung

    Bandung, Bandung, 40161

    Dr. Eddy Fadlyana, dr., Sp.A(K)., Mkes, Doctor, +62 811-2320 - 259, edfadlyana@yahoo.com

    Not yet recruiting

  • Faculty of Medicine, padjadjaran University

    Bandung, Bandung

    Dr. Eddy Fadlyana, dr., Sp.A(K), M.Kes, Doctor, +62 811-2320 - 259, edfadlyana@yahoo.com

    Recruiting

  • Faculty of Medicine Udayana University

    Denpasar, Bali, 80114

    Dr. dr. I Gusti Ayu Trisna Windiani, Sp.A(K), Doctor, +62 813-3879-9222, trisnawindianidr@yahoo.co.id

    Not yet recruiting

Other trials in Indonesia

About this study

Official title: A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered with Hexavalent Vaccine At 2, 4 and 12-15 Months of Age to Healthy Infants in Indonesia

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.

Being tested
pneumococcal disease prevention
Keywords
PCV13, Hexavalent Vaccine, Prevenar 13, Co-administration
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pneumococcal disease preventionBiological

    2P+1 programme of PCV13

Study groups in NCT06608199
Study groupRoleWhat they receive
PCV13-DT/TT(Pneuminvac)Experimental250 infants will be administered with Minhai's PCV13-DT/TT(Pneuminvac)
Receives: Biological: pneumococcal disease prevention
PCV13(Prenenar13)Active comparator250 infants will be administered with Prenenar13
Receives: Biological: pneumococcal disease prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immugenocity

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

    Measured: 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)

  1. Safety

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

    Measured: 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

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

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

  3. Safety

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

    Measured: 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start1 Nov 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06608199
Sponsor's protocol ID
S20210036-5
Status last verified
Mar 2025
First submitted
19 Sep 2024
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pneumococcal disease prevention in people with Pneumococcal Vaccines and Pneumococcal Infections, run by Beijing Minhai Biotechnology Co., Ltd at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immugenocity (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06608199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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