Trial of Simplified Pneumococcal Vaccination in Vietnam II

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach

Conditions
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Pneumococcal Vaccine

Intervention / Treatment
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* Biological: PCV Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blind, open-label, randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: V - PCV10 vaccine, 0+1<br>PCV10, 0+1 schedule. PCV vaccine at 12 months of age | Biological: PCV Vaccine<br>* PCV vaccination<br>|
| Active Comparator: W - PCV13 vaccine, 0+1<br>PCV13 in 0+1 schedule. PCV vaccine at 12 months of age | Biological: PCV Vaccine<br>* PCV vaccination<br>|
| Active Comparator: X - PCV10 vaccine, 1+1<br>PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age | Biological: PCV Vaccine<br>* PCV vaccination<br>|
| Active Comparator: Y - PCV13 vaccine, 1+1<br>PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age | Biological: PCV Vaccine<br>* PCV vaccination<br>|
| Other: Z - Control<br>Control group. PCV vaccine given at end of study (24 months) | Biological: PCV Vaccine<br>* PCV vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |