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Reduced PCV Dosing Schedules in South African Infants

NCT02943902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-12-09

No results posted yet for this study

Summary

This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule), and compare this immune response to those who receive a two dose primary series (at 6 and 14 weeks of age) and booster dose at 9-months (2+1 schedule).

Conditions

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks

PCV10 1+1, 6 weeks \& 9 months

BIOLOGICAL

Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks

PCV10 1+1, 14 weeks \& 9 months

BIOLOGICAL

Pneumococcal conjugate vaccine (PCV10 ) 2+1

PCV10 2+1, 6\&14 weeks \& 9 months

BIOLOGICAL

Pneumococcal conjugate vaccine (PCV13 ) 1+1, 6 weeks

PCV13 1+1, 6 weeks \& 9 months

BIOLOGICAL

Pneumococcal conjugate vaccine (PCV13 ) 1+1, 14 weeks

PCV13 1+1, 14 weeks \& 9 months

BIOLOGICAL

Pneumococcal conjugate vaccine (PCV13 ) 2+1

PCV13 2+1, 6\&14 weeks \& 9 months

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Shabir A Madhi, MD, PhD · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Weeks
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2019-02-26
Completion
2019-02-26

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02943902 on ClinicalTrials.gov