NCT00164411

Brief Summary

The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

First QC Date

September 9, 2005

Last Update Submit

March 13, 2012

Conditions

Pneumococcal Infections

Keywords

Diptheria-Tetanus vaccinePneumococcal vaccineAdverse events following vaccinationImmunizationImmunogenicity

Outcome Measures

Primary Outcomes (2)

  • ELISA for S. pneumoniae antibody 2 months after receiving PPV23

  • Functional S. pneumoniae antibody 2 months after receiving PPV23

Secondary Outcomes (1)

  • Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination

Interventions

Tetanus-diphtheria toxoids (Td)BIOLOGICAL
7-valent pneumococcal conjugate vaccineBIOLOGICAL
23-valent polysaccharide vaccineBIOLOGICAL

Eligibility Criteria

Age50 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start
  • Any vaccination within 2 weeks prior to first study vaccine
  • Evidence of systemic or local infection within one week prior to first study vaccine
  • HIV infection
  • Renal failure
  • Receipt of a pneumococcal or Td vaccine within 5 years
  • Current receipt of therapy for neoplastic disease
  • Current receipt of immunosuppressive therapy
  • Terminal illness withlife expectancy less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Harry L Keyserling, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2004

Study Completion

March 1, 2005

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

US(1)