Trial of Simplified Pneumococcal Vaccination in Vietnam II

NCT03098628 | Completed Phase 2 DMC

• 1 other identifier: HREC36027
• Study Type: interventional
• Target: 2,501
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Immunology sub-study

  12 months post vaccination, i.e. 24 months of age

• Immunology sub-study

  12 months post last vaccination, i.e. 24 months of age

Study Arms (5)

V - PCV10 vaccine, 0+1

ACTIVE COMPARATOR

PCV10, 0+1 schedule. PCV vaccine at 12 months of age

Biological: PCV Vaccine

W - PCV13 vaccine, 0+1

ACTIVE COMPARATOR

PCV13 in 0+1 schedule. PCV vaccine at 12 months of age

Biological: PCV Vaccine

X - PCV10 vaccine, 1+1

ACTIVE COMPARATOR

PCV10, 1+1 schedule. PCV vaccine given at 2 and 12 months of age

Biological: PCV Vaccine

Y - PCV13 vaccine, 1+1

ACTIVE COMPARATOR

PCV13, 1+1 schedule. PCV vaccine at 2 and 12 months of age

Biological: PCV Vaccine

Z - Control

OTHER

Control group. PCV vaccine given at end of study (24 months)

Biological: PCV Vaccine

Interventions

PCV Vaccine BIOLOGICAL

PCV vaccination

V - PCV10 vaccine, 0+1; W - PCV13 vaccine, 0+1; X - PCV10 vaccine, 1+1; Y - PCV13 vaccine, 1+1; Z - Control

Eligibility Criteria

• Age: 8 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Pasteur Institute, Ho Chi Minh City: collaborator

Study Sites (1)

Pasteur Institute

Ho Chi Minh City, Vietnam

Location

Related Publications (2)

• Temple B, Tran HP, Dai VTT, Smith-Vaughan H; VPT-II Collaborator Group; Licciardi PV, Satzke C, Nguyen TV, Mulholland K. Efficacy against pneumococcal carriage and the immunogenicity of reduced-dose (0 + 1 and 1 + 1) PCV10 and PCV13 schedules in Ho Chi Minh City, Viet Nam: a parallel, single-blind, randomised controlled trial. Lancet Infect Dis. 2023 Aug;23(8):933-944. doi: 10.1016/S1473-3099(23)00061-0. Epub 2023 Apr 14.

  PMID: 37062304 DERIVED

• 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.

  PMID: 34845082 DERIVED

MeSH Terms

Interventions

five-valent pneumococcal conjugate vaccine

Study Officials

• Kim Mulholland, MD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

• Nguyen Vu Thuong, MD

  Pasteur Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-blind, open-label, randomised controlled trial

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: April 4, 2017
• Study Start: March 8, 2017
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: November 27, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)