Trial of Simplified Pneumococcal Vaccination in Vietnam II (VPTII)

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: Completed
• Conditions: Pneumococcal Vaccine
• Intervention / Treatment: Biological: PCV Vaccine

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: Interventional
• Enrollment (Actual): 2501
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / 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
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

Outcome Measure	Measure Description	Time Frame
Carriage of Vaccine Type pneumococci	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	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

Outcome Measure	Measure Description	Time Frame
Immunology sub-study	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	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

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: Pasteur Institute, Ho Chi Minh City
• Investigators: Principal Investigator: Kim Mulholland, MD, Murdoch Childrens Research Institute; Principal Investigator: Nguyen Vu Thuong, MD, Pasteur Institute

Publications and helpful links

General Publications

• Temple B, Tran HP, Dai VTT, Bright K, Uyen DY, Balloch A, Licciardi P, Nguyen CD, Satzke C, Smith-Vaughan H, Nguyen TV, Mulholland K. Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial. BMJ Open. 2021 Nov 29;11(11):e056505. doi: 10.1136/bmjopen-2021-056505.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID 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