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Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

NCT00307034 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2018-06-08

Study results available
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Summary

Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

GSK Biologicals' 10-valent pneumococcal conjugate vaccine.

Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).

BIOLOGICAL

Infanrix hexa.

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

BIOLOGICAL

Infanrix-IPV/Hib.

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-01
Primary Completion
2007-01-01
Completion
2007-01-25

Countries

  • Denmark
  • Norway
  • Slovakia
  • Sweden

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 NCT00307034 on ClinicalTrials.gov