Pneumococcal VaccinePhase 2/3VPTIINCT03098628
Trial of Simplified Pneumococcal Vaccination in Vietnam II
A Phase 2/3 study testing PCV Vaccine in people with Pneumococcal Vaccine, run by Murdoch Childrens Research Institute at 1 site in Vietnam.
Trial summary
This is a single-blind, open-label, randomised controlled trial with five groups. There are four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated. Read more about this study
- Who is it for?
- Ages 8 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccine
- What is being tested?
- PCV Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,501 participants
- Where
- 1 siteVietnam
- Study dates
- 8 Mar 2017to 11 Jun 2020
- Phase
- Phase 2/3
- 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 8 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 2 months and 2 months plus 2 weeks;
- No significant maternal or perinatal history;
- Born at or after 36 weeks gestation;
- Written and signed informed consent from parent/legal guardian;
- Lives within approximately 30 minutes of the commune health centre;
- Family anticipates living in the study area for the next 22 months
Who cannot join
- Known allergy to any component of the vaccine;
- Allergic reaction or anaphylactic reaction to any previous vaccine;
- Known immunodeficiency disorder;
- Known HIV-infected mother;
- Known thrombocytopenia or coagulation disorder;
- Administration or planned administration of any immunoglobulin or blood product since birth;
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- Severe birth defect requiring ongoing medical care;
- Chronic or progressive disease;
- Seizure disorder;
- History of severe illness;
- Receipt of any 2 month vaccines through the Expanded Programme of Immunization (EPI) program;
- Family plans on giving the infant Quinvaxem (DTP-Hib-HBV).
- Additionally, enrolment will be deferred and infants asked to return to the health centre one week later for reassessment if they have at least one of the following deferral criteria:
- Axillary temperature ≥37.5°C or ≤35.5°C;
- Acute infection, especially bacterial;
- Oral administration of corticoid therapy in past 14 days; or
- Any of the following symptoms that interfere with normal activities: crying more than usual, sleeping more than usual, or loss of appetite.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach
This is a single-blind, open-label, randomised controlled trial with five groups. There are four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.
Read the detailed description
This is a single-blind, open-label, randomised controlled trial with five groups. There are four different PCV schedules to be evaluated: a 0+1 schedule of PCV10 at 12 months of age (Group V), a 0+1 schedule of PCV13 at 12 months of age (Group W), a 1+1 schedule of PCV10 at 2 and 12 months of age (Group X), and a 1+1 schedule of PCV13 at 2 and 12 months of age (Group Y); along with a control group that receives a dose of PCV10 at 24 months of age (Group Z). Additionally, all participants will receive four doses of Infanrix-hexa at 2, 3, 4 and 18 months of age.
- Conditions
- Pneumococcal Vaccine
- Being tested
- PCV Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV VaccineBiological
PCV vaccination
| Study group | Role | What they receive |
|---|---|---|
| V - PCV10 vaccine, 0+1 | Active comparator | PCV10, 0+1 schedule. PCV vaccine at 12 months of age Receives: Biological: PCV Vaccine |
| W - PCV13 vaccine, 0+1 | Active comparator | PCV13 in 0+1 schedule. PCV vaccine at 12 months of age Receives: Biological: PCV Vaccine |
| X - PCV10 vaccine, 1+1 | Active comparator | PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age Receives: Biological: PCV Vaccine |
| Y - PCV13 vaccine, 1+1 | Active comparator | PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age Receives: Biological: PCV Vaccine |
| Z - Control | Other | Control group. PCV vaccine given at end of study (24 months) Receives: Biological: PCV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carriage of Vaccine Type pneumococci
Evaluate the effect of a 0+1 PCV schedule administered at 12 months of age on Nasopharngeal Carrige (NP) carriage during the first two years of life, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls
Measured: 12 months post vaccination, i.e. 24 months of age
Carriage of Vaccine Type pneumococci
Evaluate the effect of a 1+1 PCV schedule administered at 2 and 12 months of age on NP carriage during the first two years of life, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls.
Measured: 12 months post last vaccination, i.e. 24 months of age
Secondary outcomes (2)
Immunology sub-study
- To evaluate the immune responses to a 0+1 PCV schedule at 12 months of age, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls;
Measured: 12 months post vaccination, i.e. 24 months of age
Immunology sub-study
ii) To evaluate the immune responses to a 1+1 PCV schedule at 2 and 12 months of age, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls;
Measured: 12 months post last vaccination, i.e. 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start8 Mar 2017
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal VaccineStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, open-label, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pasteur Institute, Ho Chi Minh City
- Responsible party
- Sponsor
- Investigators
- Kim Mulholland, MD, Principal investigator, Murdoch Childrens Research InstituteNguyen Vu Thuong, MD, Principal investigator, Pasteur Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098628
- Sponsor's protocol ID
- HREC36027
- Acronym
- VPTII
- Status last verified
- Aug 2023
- First submitted
- 1 Mar 2017
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temple B, Tran HP, Dai VTT, Smith-Vaughan H; VPT-II Collaborator Group; Licciardi PV, Satzke C, Nguyen TV, Mulholland K. Efficacy against pneumococcal carriage and the immunogenicity of reduced-dose (0 + 1 and 1 + 1) PCV10 and PCV13 schedules in Ho Chi Minh City, Viet Nam: a parallel, single-blind, randomised controlled trial. Lancet Infect Dis. 2023 Aug;23(8):933-944. doi: 10.1016/S1473-3099(23)00061-0. Epub 2023 Apr 14.
PubMed 37062304Temple B, Tran HP, Dai VTT, Bright K, Uyen DY, Balloch A, Licciardi P, Nguyen CD, Satzke C, Smith-Vaughan H, Nguyen TV, Mulholland K. Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial. BMJ Open. 2021 Nov 29;11(11):e056505. doi: 10.1136/bmjopen-2021-056505.
PubMed 34845082
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach
- ClinicalTrials.gov ID
- NCT03098628
- Acronym / sponsor ID
- VPTII / HREC36027
- Conditions
- Pneumococcal Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,501 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Pasteur Institute, Ho Chi Minh City
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 4 Apr 2017 (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.
This is a single-blind, open-label, randomised controlled trial with five groups. There are four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.
Detailed description
This is a single-blind, open-label, randomised controlled trial with five groups. There are four different PCV schedules to be evaluated: a 0+1 schedule of PCV10 at 12 months of age (Group V), a 0+1 schedule of PCV13 at 12 months of age (Group W), a 1+1 schedule of PCV10 at 2 and 12 months of age (Group X), and a 1+1 schedule of PCV13 at 2 and 12 months of age (Group Y); along with a control group that receives a dose of PCV10 at 24 months of age (Group Z). Additionally, all participants will receive four doses of Infanrix-hexa at 2, 3, 4 and 18 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- single-blind, open-label, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| V - PCV10 vaccine, 0+1 | Active comparator | Biological: PCV VaccinePCV10, 0+1 schedule. PCV vaccine at 12 months of age |
| W - PCV13 vaccine, 0+1 | Active comparator | Biological: PCV VaccinePCV13 in 0+1 schedule. PCV vaccine at 12 months of age |
| X - PCV10 vaccine, 1+1 | Active comparator | Biological: PCV VaccinePCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age |
| Y - PCV13 vaccine, 1+1 | Active comparator | Biological: PCV VaccinePCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age |
| Z - Control | Other | Biological: PCV VaccineControl group. PCV vaccine given at end of study (24 months) |
Who may qualify
- Ages
- 8 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 2 months and 2 months plus 2 weeks;
- No significant maternal or perinatal history;
- Born at or after 36 weeks gestation;
- Written and signed informed consent from parent/legal guardian;
- Lives within approximately 30 minutes of the commune health centre;
Key exclusion criteria (17 listed)
- Known allergy to any component of the vaccine;
- Allergic reaction or anaphylactic reaction to any previous vaccine;
- Known immunodeficiency disorder;
- Known HIV-infected mother;
- Known thrombocytopenia or coagulation disorder;
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 |
|---|---|---|
| PCV VaccinePCV vaccination | Biological | V - PCV10 vaccine, 0+1, W - PCV13 vaccine, 0+1, X - PCV10 vaccine, 1+1, Y - PCV13 vaccine, 1+1, Z - Control |
Primary outcome
Carriage of Vaccine Type pneumococci
Time frame: 12 months post vaccination, i.e. 24 months of age
Evaluate the effect of a 0+1 PCV schedule administered at 12 months of age on Nasopharngeal Carrige (NP) carriage during the first two years of life, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls
Carriage of Vaccine Type pneumococci
Time frame: 12 months post last vaccination, i.e. 24 months of age
Evaluate the effect of a 1+1 PCV schedule administered at 2 and 12 months of age on NP carriage during the first two years of life, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls.
2 secondary outcomes
Immunology sub-study
Time frame: 12 months post vaccination, i.e. 24 months of age
Immunology sub-study
Time frame: 12 months post last vaccination, i.e. 24 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 37062304Temple B, Tran HP, Dai VTT, Smith-Vaughan H; VPT-II Collaborator Group; Licciardi PV, Satzke C, Nguyen TV, Mulholland K. Efficacy against pneumococcal carriage and the immunogenicity of reduced-dose (0 + 1 and 1 + 1) PCV10 and PCV13 schedules in Ho Chi Minh City, Viet Nam: a parallel, single-blind, randomised controlled trial. Lancet Infect Dis. 2023 Aug;23(8):933-944. doi: 10.1016/S1473-3099(23)00061-0. Epub 2023 Apr 14.
- Derived from this study: PubMed 34845082Temple B, Tran HP, Dai VTT, Bright K, Uyen DY, Balloch A, Licciardi P, Nguyen CD, Satzke C, Smith-Vaughan H, Nguyen TV, Mulholland K. Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial. BMJ Open. 2021 Nov 29;11(11):e056505. doi: 10.1136/bmjopen-2021-056505.
- 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.
Kim Mulholland, MD principal investigator
Murdoch Childrens Research Institute
Nguyen Vu Thuong, MD principal investigator
Pasteur Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PCV Vaccine in people with Pneumococcal Vaccine, run by Murdoch Childrens Research Institute at 1 site in Vietnam.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carriage of Vaccine Type pneumococci (time frame: 12 months post vaccination, i.e. 24 months of age). The study lists 2 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 NCT03098628, which also lists 2 linked publications.
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 27 Nov 2024.