MedTrace Logo

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

NCT01641133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2021-03-02

Study results available
· View outcomes & findings →

Summary

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

Conditions

  • Infections, Streptococcal
  • Streptococcus Pneumoniae Vaccines

Interventions

BIOLOGICAL

Synflorix (3-Dose)

3 doses administered intramuscularly

BIOLOGICAL

Synflorix (2-Dose)

2 doses administered intramuscularly

BIOLOGICAL

Synflorix (Single Dose)

1 dose administered intramuscularly

BIOLOGICAL

Prevenar 13 (Single Dose)

1 dose administered intramuscularly

BIOLOGICAL

Prevenar 13 (2-Dose)

2 doses administered intramuscularly

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-04
Primary Completion
2013-07-15
Completion
2014-05-07

Countries

  • Mexico

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 NCT01641133 on ClinicalTrials.gov