MedTrace Logo

Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

NCT00985751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2020-11-05

Study results available
· View outcomes & findings →

Summary

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \>40.0°C).

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal vaccine GSK2189242A (formulation 1)

Three doses will be administered intramuscularly, at Month 0, 2 and 6.

BIOLOGICAL

Pneumococcal vaccine GSK2189242A (formulation 2)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

BIOLOGICAL

Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

BIOLOGICAL

Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

BIOLOGICAL

Pneumococcal vaccine GSK1024850A

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-24
Primary Completion
2010-10-12
Completion
2011-03-02

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Companies

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 NCT00985751 on ClinicalTrials.gov