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| Name | Class |
|---|---|
| Pasteur Institute, Ho Chi Minh City | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V - PCV10 vaccine, 0+1 | Active Comparator | PCV10, 0+1 schedule. PCV vaccine at 12 months of age |
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| W - PCV13 vaccine, 0+1 | Active Comparator | PCV13 in 0+1 schedule. PCV vaccine at 12 months of age |
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| X - PCV10 vaccine, 1+1 | Active Comparator | PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age |
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| Y - PCV13 vaccine, 1+1 | Active Comparator | PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age |
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| Z - Control | Other | Control group. PCV vaccine given at end of study (24 months) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV Vaccine | Biological | PCV vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 12 months post last vaccination, i.e. 24 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Immunology sub-study | i) 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; | 12 months post vaccination, i.e. 24 months of age |
| Immunology sub-study |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Mulholland, MD | Murdoch Childrens Research Institute | Principal Investigator |
| Nguyen Vu Thuong, MD | Pasteur Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pasteur Institute | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37062304 | Derived | 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. | |
| 34845082 |
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| ID | Term |
|---|---|
| C105256 | five-valent pneumococcal conjugate vaccine |
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single-blind, open-label, randomised controlled trial
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This is a single-blind, open-label, randomised trial, with laboratory staff blinded to study group allocation as all the outcome measures that address the study objectives are laboratory based. Laboratory samples will be labelled with a unique trial identification number that does not identify the study group. Given the different timing of the vaccine schedules in the different study arms, the study nurses, vaccine administrators and participants will not be blinded to the study group allocation of each infant.
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; |
| 12 months post last vaccination, i.e. 24 months of age |
| Derived |
| Temple 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. |