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Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants

NCT00390910 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2018-12-17

Study results available
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Summary

This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.

This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 3 doses

BIOLOGICAL

Infanrix hexa

Intramuscular injection, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-01
Primary Completion
2007-07-02
Completion
2008-05-02

Countries

  • Greece
  • Spain

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 NCT00390910 on ClinicalTrials.gov