Trial | NCT03098628  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2501
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.
Study Started
Mar 08
2017
Primary Completion
Jun 11
2020
Study Completion
Jun 11
2020
Last Update
Aug 24
2023

Biological PCV Vaccine

PCV vaccination

V - PCV10 vaccine, 0+1 Active Comparator

PCV10, 0+1 schedule. PCV vaccine at 12 months of age

W - PCV13 vaccine, 0+1 Active Comparator

PCV13 in 0+1 schedule. PCV vaccine at 12 months of age

X - PCV10 vaccine, 1+1 Active Comparator

PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age

Y - PCV13 vaccine, 1+1 Active Comparator

PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age

Z - Control Other

Control group. PCV vaccine given at end of study (24 months)

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.
No Results Posted