Trial of Simplified Pneumococcal Vaccination in Vietnam II

Murdoch Childrens Research Institute2,501 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

2,501

Conditions

Pneumococcal Vaccine

Interventions

PCV VaccineBIOLOGICAL

PCV vaccination

Eligibility

Sex: ALLMin age: 8 WeeksMax age: 10 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pasteur Institute

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

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

Time frame: 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.

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

Secondary Outcomes

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;

Time frame: 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;

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

Data from ClinicalTrials.gov

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