Streptococcus PneumoniaPNEUMOSILNCT05140720
Assess the Safety and Immunogenicity of PNEUMOSIL® Vaccine in Healthy Vietnamese Children, 6 Weeks to 24 Months of Age
A study testing PNEUMOSIL® in people with Streptococcus Pneumonia and Vaccine Preventable Disease, run by Vabiotech.
Trial summary
The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study. Read more about this study
- Who is it for?
- Ages 6 weeks to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumonia, Vaccine Preventable Disease
- What is being tested?
- PNEUMOSIL®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 weeks to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants or toddlers, based on medical history and clinical assessment, to be without acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or illness that requires medical therapy.
- Infants or toddlers between 6 weeks to 24 months of age at the first dose
- Voluntary written informed consent by subject's parents to have the subject participate in the study.
- Subject's parents being able to comprehend and comply with study requirements and procedures and able and willing to complete subject diary, to return with the subject for all scheduled follow-up visits
- Subjects born full-term with a weight-to-length Z score of ≥ -2 (WHO child growth standard) at enrollment.
- Subject with an up-to-date minimal vaccination status for age at the time of enrollment as per National Immunization Program.
- Subject's parents having a readily identifiable place of residence in the study area, being available for the duration of trial participation, with means of telephone contact.
Who cannot join
- Use of any investigational medicinal product prior to randomization or planned use of such a product (other than study vaccine) during the period of study participation. Previous vaccination against Streptococcus pneumoniae.
- History of Streptococcus pneumoniae infection confirmed by culture from a normally sterile site.
- History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. This included such reactions in older siblings and also includes all components of the vaccines of expanded program on immunization.
- History of anaphylactic shock.
- Any abnormal (Grade ≥ 1) vital sign. Note: For fever, axillary temperature of ≥ 37.5°C was considered significant and was repeated to determine whether a subject is eligible for randomization. A minimum of 48 hours following resolution of documented fever needed to pass before the subject could be reassessed for eligibility. The last vital sign measurement was used as the baseline value for the study.
- Any moderate or severe (Grade ≥ 2) acute illness Note: Infants with a Grade 1 acute illness were enrolled at the discretion of the Principal Investigator (PI).
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- Note: Subjects with moderate or severe acute illness would return for clinical reassessment; if the illness had sufficiently resolved, they might still qualify for randomization.
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine, including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
- History of administration of a non-study pneumococcal vaccine prior to administration of study vaccine or during the course of study participation (other vaccinations of expanded program on Immunization are accepted).
- Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
- History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., coagulation factor deficiencies, severe anemia at birth). Any clearly documented history in a first-degree relative (e.g., parent, sibling) of the same was also exclusionary.
- History of suspected primary immunodeficiency. Any clearly documented history in a first-degree relative of the same was also exclusionary.
- Subject had a sibling die of likely sudden infant death syndrome or die suddenly and without apparent other cause or preceding illness in the first year of life.
- Evidence of a clinically significant congenital abnormality as judged by the PI.
- History of meningitis, seizures or any neurological disorder.
- Evidence by history taking alone of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other blood-borne mechanisms.
- Subject being a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or department.
- Any medical or social condition that in the opinion of the PI might interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
- Note: The specific exclusion criteria (e.g., abnormal vital sign, acute illness) were reassessed at all vaccination visits. Any subject who was not vaccinated due to an acute abnormality assessed at the 2nd or 3rd vaccination visit (V2 or V3) would return once the acute issue has resolved. A minimum of 48 hours must have passed after a documented fever before a subject could be vaccinated. This safety requirement was not deemed a protocol deviation if the visit fell outside the vaccination window; however, it was encouraged to maintain the vaccination window whenever possible in these situations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assess the Safety and Immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 Weeks to 24 Months of Age
The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study.
Read the detailed description
In this open label, prospective, bridging study, 300 healthy infants and toddlers will be recruited into the study three pre-defined age groups:
Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months
Study subjects will be vaccinated PNEUMOSIL® with the primary doses: Age group 1 with 3 doses, Age group 2 and Age group 3 with 2 doses.
Immunogenicity blood sample for Immunoglobulin G (IgG) will be taken in 35 subjects who completed primary dose series.
- Being tested
- PNEUMOSIL®
- Keywords
- pneumonia, Pneumococcal vaccine, Vaccine, healthy infants and toddlers
- Medical subject headings
- Pneumonia, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEUMOSIL®Biological
Study subjects will be vaccinated PNEUMOSIL® with the primary doses as described below:
Group 1: 3 doses, 4 to 8 week interval Group 2: 2 doses, dose interval > 1 month Group 3: 2 doses, dose interval > 2 months
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks - 6 months of age | Experimental | Group 1: Age group from 6 weeks - 6 months Receives: Biological: PNEUMOSIL® |
| 7 - 11 months of age | Experimental | Group 2: Age group from 7 - 11 months Receives: Biological: PNEUMOSIL® |
| 12 - 24 months of age | Experimental | Group 3: Age group from 12 - 24 months Receives: Biological: PNEUMOSIL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants with immediate solicited adverse events (AEs), serious adverse events (SAEs) at least 30 minutes after each study vaccine administration.
The incidence and severity of immediate solicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.
Measured: 30 minutes after each vaccination
Percent of participants with solicited AEs, SAEs within 7 days after each study vaccine administration.
The incidence and severity of solicited local and systemic AEs, SAEs within 7 days after each dose of the study vaccine.
Measured: within 7 days after each vaccination
Percent of participants with solicited AEs, SAEs within 28 days after each dose of the study vaccine.
The incidence and severity of solicited local and systemic AEs, SAEs within 28 days after each dose of the study vaccine
Measured: within 28 days after each vaccination
Percent of participants with immediate unsolicited AEs, SAEs at least 30 minutes after each study vaccine administration.
The incidence and severity of immediate unsolicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.
Measured: 30 minutes after each vaccination
Percent of participants with unsolicited AEs, SAEs until 28 days after the last primary dose.
Percent of participants with unsolicited local and systemic AEs, SAEs from the first primary dose to 28 days after the last primary dose vaccination.
Measured: From the first primary dose to 28 days after the last primary dose vaccination.
Secondary outcomes (2)
Geometric mean (μg/mL) of IgG concentration for each serotype at 28 days after the last primary dose.
Measured: at 28 days after the last primary dose.
Proportion of patients achieving seroconversion with IgG > 0.35 μg/mL as defined by WHO at 28 days after the last primary dose.
Measured: at 28 days after the last primary dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start25 Jan 2022 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Streptococcus PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This will be an open label, prospective, bridging study. Pneumococcal conjugate vaccine (PCV)-native subjects in three pre-defined age groups will be recruited into the study. Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months Study subjects will be vaccinated with the primary doses. The dose of 0.5 ml of study vaccine has been selected based on the results from previous clinical studies and in compliance with the approval for marketing authorization in India.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vabiotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research
- Responsible party
- Sponsor
- Investigators
- Son T Vu, PhD, Principal investigator, Vietnam Military Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140720
- Sponsor's protocol ID
- VX.2020.07
- Acronym
- PNEUMOSIL
- Status last verified
- Aug 2021
- First submitted
- 26 Sep 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Son VT, Anh BDT, Hoan VN, Than HV, Linh BK, Giang TH, Manh NT, Thao LTT, Cuong HX, Giang DT, Dat DT, Giang LTH, Mulay SC, Sethna V, Hung PV. Safety and Immunogenicity of SII's 10-Valent Pneumococcal Conjugate Vaccine (PCV10-SII) in Vietnamese Children Aged from 6 Weeks to 24 Months: An Open-Label, Single-Arm Bridging Study. Vaccines (Basel). 2026 Apr 10;14(4):336. doi: 10.3390/vaccines14040336.
PubMed 42042812
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Safety and Immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 Weeks to 24 Months of Age
- ClinicalTrials.gov ID
- NCT05140720
- Acronym / sponsor ID
- PNEUMOSIL / VX.2020.07
- Keywords
- pneumonia, Pneumococcal vaccine, Vaccine, healthy infants and toddlers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- VabiotechIndustry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research
- Study start
- 25 Jan 2022 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study.
Detailed description
In this open label, prospective, bridging study, 300 healthy infants and toddlers will be recruited into the study three pre-defined age groups:
Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months
Study subjects will be vaccinated PNEUMOSIL® with the primary doses: Age group 1 with 3 doses, Age group 2 and Age group 3 with 2 doses.
Immunogenicity blood sample for Immunoglobulin G (IgG) will be taken in 35 subjects who completed primary dose series.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This will be an open label, prospective, bridging study. Pneumococcal conjugate vaccine (PCV)-native subjects in three pre-defined age groups will be recruited into the study. Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months Study subjects will be vaccinated with the primary doses. The dose of 0.5 ml of study vaccine has been selected based on the results from previous clinical studies and in compliance with the approval for marketing authorization in India.
| Arm | Type | Receives |
|---|---|---|
| 6 weeks - 6 months of age | Experimental | Biological: PNEUMOSIL®Group 1: Age group from 6 weeks - 6 months |
| 7 - 11 months of age | Experimental | Biological: PNEUMOSIL®Group 2: Age group from 7 - 11 months |
| 12 - 24 months of age | Experimental | Biological: PNEUMOSIL®Group 3: Age group from 12 - 24 months |
Who may qualify
- Ages
- 6 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy infants or toddlers, based on medical history and clinical assessment, to be without acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or illness that requires medical therapy.
- Infants or toddlers between 6 weeks to 24 months of age at the first dose
- Voluntary written informed consent by subject's parents to have the subject participate in the study.
- Subject's parents being able to comprehend and comply with study requirements and procedures and able and willing to complete subject diary, to return with the subject for all scheduled follow-up visits
- Subjects born full-term with a weight-to-length Z score of ≥ -2 (WHO child growth standard) at enrollment.
Key exclusion criteria (19 listed)
- Use of any investigational medicinal product prior to randomization or planned use of such a product (other than study vaccine) during the period of study participation. Previous vaccination against Streptococcus pneumoniae.
- History of Streptococcus pneumoniae infection confirmed by culture from a normally sterile site.
- History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. This included such reactions in older siblings and also includes all components of the vaccines of expanded program on immunization.
- History of anaphylactic shock.
- Any abnormal (Grade ≥ 1) vital sign. Note: For fever, axillary temperature of ≥ 37.5°C was considered significant and was repeated to determine whether a subject is eligible for randomization. A minimum of 48 hours following resolution of documented fever needed to pass before the subject could be reassessed for eligibility. The last vital sign measurement was used as the baseline value for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNEUMOSIL®Study subjects will be vaccinated PNEUMOSIL® with the primary doses as described below: Group 1: 3 doses, 4 to 8 week interval Group 2: 2 doses, dose interval > 1 month Group 3: 2 doses, dose interval > 2 months | Biological | 12 - 24 months of age, 6 weeks - 6 months of age, 7 - 11 months of age |
Primary outcome
Percent of participants with immediate solicited adverse events (AEs), serious adverse events (SAEs) at least 30 minutes after each study vaccine administration.
Time frame: 30 minutes after each vaccination
The incidence and severity of immediate solicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.
Percent of participants with solicited AEs, SAEs within 7 days after each study vaccine administration.
Time frame: within 7 days after each vaccination
The incidence and severity of solicited local and systemic AEs, SAEs within 7 days after each dose of the study vaccine.
Percent of participants with solicited AEs, SAEs within 28 days after each dose of the study vaccine.
Time frame: within 28 days after each vaccination
The incidence and severity of solicited local and systemic AEs, SAEs within 28 days after each dose of the study vaccine
Percent of participants with immediate unsolicited AEs, SAEs at least 30 minutes after each study vaccine administration.
Time frame: 30 minutes after each vaccination
The incidence and severity of immediate unsolicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.
Percent of participants with unsolicited AEs, SAEs until 28 days after the last primary dose.
Time frame: From the first primary dose to 28 days after the last primary dose vaccination.
Percent of participants with unsolicited local and systemic AEs, SAEs from the first primary dose to 28 days after the last primary dose vaccination.
2 secondary outcomes
Geometric mean (μg/mL) of IgG concentration for each serotype at 28 days after the last primary dose.
Time frame: at 28 days after the last primary dose.
Proportion of patients achieving seroconversion with IgG > 0.35 μg/mL as defined by WHO at 28 days after the last primary dose.
Time frame: at 28 days after the last primary dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 42042812Son VT, Anh BDT, Hoan VN, Than HV, Linh BK, Giang TH, Manh NT, Thao LTT, Cuong HX, Giang DT, Dat DT, Giang LTH, Mulay SC, Sethna V, Hung PV. Safety and Immunogenicity of SII's 10-Valent Pneumococcal Conjugate Vaccine (PCV10-SII) in Vietnamese Children Aged from 6 Weeks to 24 Months: An Open-Label, Single-Arm Bridging Study. Vaccines (Basel). 2026 Apr 10;14(4):336. doi: 10.3390/vaccines14040336.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Son T Vu, PhD principal investigator
Vietnam Military Medicine University
Questions about this trial
What is this clinical trial studying?
A study testing PNEUMOSIL® in people with Streptococcus Pneumonia and Vaccine Preventable Disease, run by Vabiotech.
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 7 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: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Son T Vu, PhD (+84988350535, vutungson1983@vmmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants with immediate solicited adverse events (AEs), serious adverse events (SAEs) at least 30 minutes after each study vaccine administration. (time frame: 30 minutes after each vaccination). The study lists 5 primary outcomes in all. 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 NCT05140720, which also lists 1 linked publication.
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 1 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.