Clinical trial NCT03098628: Trial of Simplified Pneumococcal Vaccination in Vietnam II
Official title: Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pneumococcal Vaccine
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Pasteur Institute, Ho Chi Minh City
First posted: 2017-04-04
Enrollment: 2501
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, open-label, randomised controlled trial
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Carriage of Vaccine Type pneumococci
timeFrame: 12 months post vaccination, i.e. 24 months of age
measure: Carriage of Vaccine Type pneumococci
timeFrame: 12 months post last vaccination, i.e. 24 months of age
Secondary outcomes:
measure: Immunology sub-study
timeFrame: 12 months post vaccination, i.e. 24 months of age
measure: Immunology sub-study
timeFrame: 12 months post last vaccination, i.e. 24 months of age
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Pasteur Institute
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Kim Mulholland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pasteur Institute
name: Nguyen Vu Thuong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.