World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 4 September 2023
Main ID:  NCT03098628
Date of registration: 01/03/2017
Prospective Registration: Yes
Primary sponsor: Murdoch Childrens Research Institute
Public title: Trial of Simplified Pneumococcal Vaccination in Vietnam II VPTII
Scientific title: Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach
Date of first enrolment: March 8, 2017
Target sample size: 2501
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT03098628
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).  
Phase:  Phase 2/Phase 3
Countries of recruitment
Vietnam
Contacts
Name:     Nguyen Vu Thuong, MD
Address: 
Telephone:
Email:
Affiliation:  Pasteur Institute
Name:     Kim Mulholland, MD
Address: 
Telephone:
Email:
Affiliation:  Murdoch Childrens Research Institute
Key inclusion & exclusion criteria

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.



Age minimum: 2 Months
Age maximum: 10 Weeks
Gender: All
Health Condition(s) or Problem(s) studied
Pneumococcal Vaccine
Intervention(s)
Biological: PCV Vaccine
Primary Outcome(s)
Carriage of Vaccine Type pneumococci [Time Frame: 12 months post vaccination, i.e. 24 months of age]
Carriage of Vaccine Type pneumococci [Time Frame: 12 months post last vaccination, i.e. 24 months of age]
Secondary Outcome(s)
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]
Secondary ID(s)
HREC36027
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Pasteur Institute, Ho Chi Minh City
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history