Trial of Simplified Pneumococcal Vaccination in Vietnam II

Pneumococcal Vaccine Clinical Trial

— VPTII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098628
• Other study ID #: HREC36027
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 8, 2017
• Est. completion date: June 11, 2020

Study information

• Verified date: August 2023
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2501
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 10 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Vaccine

Intervention

Biological:
• PCV Vaccine
PCV vaccination

Locations

Country	Name	City	State
Vietnam	Pasteur Institute	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Pasteur Institute, Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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