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Trial of Simplified Pneumococcal Vaccination in Vietnam II (VPTII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098628
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Pasteur Institute, Ho Chi Minh City
Information provided by (Responsible Party):
Kim Mulholland, 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.

Condition or disease Intervention/treatment Phase
Pneumococcal Vaccine Biological: PCV Vaccine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blind, open-label, randomised controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: This is a single-blind, open-label, randomised trial, with laboratory staff blinded to study group allocation as all the outcome measures that address the study objectives are laboratory based. Laboratory samples will be labelled with a unique trial identification number that does not identify the study group. Given the different timing of the vaccine schedules in the different study arms, the study nurses, vaccine administrators and participants will not be blinded to the study group allocation of each infant.
Primary Purpose: Prevention
Official Title: Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach
Actual Study Start Date : March 8, 2018
Actual Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 30, 2021

Arm Intervention/treatment
Active Comparator: V - PCV10 vaccine, 0+1
PCV10, 0+1 schedule. PCV vaccine at 12 months of age
Biological: PCV Vaccine
PCV vaccination

Active Comparator: W - PCV13 vaccine, 0+1
PCV13 in 0+1 schedule. PCV vaccine at 12 months of age
Biological: PCV Vaccine
PCV vaccination

Active Comparator: X - PCV10 vaccine, 1+1
PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age
Biological: PCV Vaccine
PCV vaccination

Active Comparator: Y - PCV13 vaccine, 1+1
PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age
Biological: PCV Vaccine
PCV vaccination

Z - Control
Control group. PCV vaccine given at end of study (24 months)
Biological: PCV Vaccine
PCV vaccination




Primary Outcome Measures :
  1. Carriage of Vaccine Type pneumococci [ Time Frame: 12 months post vaccination, i.e. 24 months of age ]
    Evaluate the effect of a 0+1 PCV schedule administered at 12 months of age on Nasopharngeal Carrige (NP) carriage during the first two years of life, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls

  2. Carriage of Vaccine Type pneumococci [ Time Frame: 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 :
  1. Immunology sub-study [ Time Frame: 12 months post vaccination, i.e. 24 months of age ]
    i) To evaluate the immune responses to a 0+1 PCV schedule at 12 months of age, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls;

  2. Immunology sub-study [ Time Frame: 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;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03098628


Locations
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Vietnam
Pasteur Institute
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Kim Mulholland
Pasteur Institute, Ho Chi Minh City
Investigators
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Principal Investigator: Kim Mulholland, MD Murdoch Childrens Research Institute
Principal Investigator: Nguyen Vu Thuong, MD Pasteur Institute
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Responsible Party: Kim Mulholland, Group Leader, Professorial Fellow, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT03098628    
Other Study ID Numbers: HREC36027
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No