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Evaluation of PCV Schedules in a Naive Population in Vietnam

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ClinicalTrials.gov Identifier: NCT02961231
Recruitment Status : Not yet recruiting
First Posted : November 10, 2016
Last Update Posted : November 10, 2016
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
Murdoch Childrens Research Institute
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Prof.Lay-Myint Yoshida, Nagasaki University

Brief Summary:
The cost of pneumococcal conjugate vaccine use can be greatly reduced by making use of existing herd immunity to protect children against vaccine type pneumococci. The investigators will reduce the circulation of vaccine type pneumococci to low levels by PCV catch-up campaign; vaccinating all children less than 3 years of age with PCV, after which the investigators will evaluate the ability of a simplified two doses regimen and an alternative one dose regimen to prevent the reintroduction of vaccine type pneumococci compared to the WHO recommended 2 doses schedule.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Biological: PCV 2p+1 Biological: PCV 3p+0 Biological: PCV 1p+1 Biological: PCV 0p+1 Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of PCV Schedules in a Naive Population in Vietnam
Study Start Date : November 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: PCV 2p+1
PCV 2p+1 schedule: WHO recommended 2 primary at 2, 4 months and a booster dose at 12 month
Biological: PCV 2p+1
introduction of PCV in a reduced dosing 2p+1 schedule
Other Name: Synflorix

Active Comparator: PCV 3p+0
PCV 3p+0 schedule: WHO recommended 3 primary doses at 2, 3 and 4 months
Biological: PCV 3p+0
introduction of PCV in a reduced dosing 3p+0 schedule
Other Name: Synflorix

Experimental: PCV 1p+1
PCV 1p+1 schedule: one primary dose at 2 month and a booster at 12 month
Biological: PCV 1p+1
introduction of PCV in a reduced dosing 1p+1 schedule
Other Name: Synflorix

Experimental: PCV 0p+1
PCV 0p+1 schedule: no primary dose, only a booster at 12 month
Biological: PCV 0p+1
introduction of PCV in a reduced dosing 0p+1 schedule
Other Name: Synflorix




Primary Outcome Measures :
  1. vaccine type pneumococcal carriage [ Time Frame: up to 48 months after PCV intervention ]
    Vaccine type pneumococcal carriage among children receiving different PCV dose will be investigated yearly. Non-inferiority of 1p+1 dose will be compared with those receiving 2p+1/3p+0 groups.



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Ages Eligible for Study:   2 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: All children living in the intervention communes in Nha Trang city, whose parents or guardian give informed consent will be eligible to receive PCV in accordance with their age.

Exclusion Criteria: Children who are not fit enough to receive national vaccination program vaccine for health reason (eg.fever, currently under medication due to illness such as pneumonia, diarrhea, etc) in accordance with Vietnam national immunization guidelines. This will be decided by the medical doctor in charge of the vaccination at commune health center in accordance with Vietnamese guideline.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961231


Contacts
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Contact: LAYMYINT YOSHIDA, MBBS, PhD +81 95-819-7284 lmyoshi@nagasaki-u.ac.jp
Contact: Duc Anh Dang, PhD +84 90 322 9425 dangducanh.nihe@gmail.com

Locations
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Vietnam
Commune Health Centers Not yet recruiting
Nha Trang, Khanh Hoa, Vietnam
Contact: Duc Anh Dang, PhD    +84 90 322 9425    dangducanh.nihe@gmail.com   
Sponsors and Collaborators
Nagasaki University
National Institute of Hygiene and Epidemiology, Vietnam
Murdoch Childrens Research Institute
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: LAYMYINT YOSHIDA, MBBS, PhD Institute of Tropical Medicine, Nagasaki University, Nagasaki

Publications of Results:
Other Publications:
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Responsible Party: Prof.Lay-Myint Yoshida, Professor, Department of Pediaric Infectious Diseases, Institute of Tropical Medicine, Nagasaki University
ClinicalTrials.gov Identifier: NCT02961231     History of Changes
Other Study ID Numbers: OPP1139859
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof.Lay-Myint Yoshida, Nagasaki University:
Pneumococcal conjugate vaccine
Herd immunity
Reduced dosing schedule

Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial