Trial of Simplified Pneumococcal Vaccination in Vietnam II
- Registration Number
- NCT03098628
- Lead Sponsor
- Murdoch Childrens Research Institute
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2501
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description W - PCV13 vaccine, 0+1 PCV Vaccine PCV13 in 0+1 schedule. PCV vaccine at 12 months of age Y - PCV13 vaccine, 1+1 PCV Vaccine PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age V - PCV10 vaccine, 0+1 PCV Vaccine PCV10, 0+1 schedule. PCV vaccine at 12 months of age X - PCV10 vaccine, 1+1 PCV Vaccine PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age Z - Control PCV Vaccine Control group. PCV vaccine given at end of study (24 months)
- Primary Outcome Measures
Name Time Method Carriage of Vaccine Type pneumococci 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.
- Secondary Outcome Measures
Name Time Method Immunology sub-study 12 months post last vaccination, i.e. 24 months of age 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;
Trial Locations
- Locations (1)
Pasteur Institute
🇻🇳Ho Chi Minh City, Vietnam