Trial of Simplified Pneumococcal Vaccination in Vietnam II (VPTII)

November 24, 2024 updated by: Murdoch Childrens Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2501

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Pasteur Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Z - Control
Control group. PCV vaccine given at end of study (24 months)
Biological: PCV Vaccine
PCV vaccination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months post vaccination, i.e. 24 months of age
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.
12 months post last vaccination, i.e. 24 months of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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;
12 months post vaccination, i.e. 24 months of age
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;
12 months post last vaccination, i.e. 24 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Murdoch Childrens Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pasteur Institute, Ho Chi Minh City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kim Mulholland, MD, Murdoch Childrens Research Institute
  • Principal Investigator: Nguyen Vu Thuong, MD, Pasteur Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREC36027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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