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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

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE March 8, 2018
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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 NP carriage during the first two years of life, comparing a) PCV10-vaccinated and b) PCV13-vaccinated participants with unvaccinated controls
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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;
  • 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;
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Simplified Pneumococcal Vaccination in Vietnam II
Official Title  ICMJE Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Pneumococcal Vaccine
Intervention  ICMJE Biological: PCV Vaccine
PCV vaccination
Study Arms  ICMJE
  • Active Comparator: V - PCV10 vaccine, 0+1
    PCV10, 0+1 schedule. PCV vaccine at 12 months of age
    Intervention: Biological: PCV Vaccine
  • Active Comparator: W - PCV13 vaccine, 0+1
    PCV13 in 0+1 schedule. PCV vaccine at 12 months of age
    Intervention: Biological: PCV Vaccine
  • Active Comparator: X - PCV10 vaccine, 1+1
    PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age
    Intervention: Biological: PCV Vaccine
  • Active Comparator: Y - PCV13 vaccine, 1+1
    PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age
    Intervention: Biological: PCV Vaccine
  • Z - Control
    Control group. PCV vaccine given at end of study (24 months)
    Intervention: Biological: PCV Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
2501
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2017)
2500
Estimated Study Completion Date  ICMJE March 30, 2021
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 10 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098628
Other Study ID Numbers  ICMJE HREC36027
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kim Mulholland, Murdoch Childrens Research Institute
Study Sponsor  ICMJE Kim Mulholland
Collaborators  ICMJE Pasteur Institute, Ho Chi Minh City
Investigators  ICMJE
Principal Investigator: Kim Mulholland, MD Murdoch Childrens Research Institute
Principal Investigator: Nguyen Vu Thuong, MD Pasteur Institute
PRS Account Murdoch Childrens Research Institute
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP