Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Centers for Disease Control and Prevention. Recruitment status was Active, not recruiting

First Received on September 9, 2005. Last Updated on November 16, 2005 History of Changes

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	Emory University
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164411

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: Tetanus-diphtheria toxoids (Td) Biological: 7-valent pneumococcal conjugate vaccine Biological: 23-valent polysaccharide vaccine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-Valent) and Tetanus/Diphtheria Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Pneumococcal Infections Pneumonia Tetanus

Drug Information available for: Tetanus Vaccine Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	January 2004
Estimated Study Completion Date:	March 2005

Detailed Description:

The only vaccine licensed in the United States for protecting adults against pneumococcal disease (PPV23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (PCV7) is licensed for children and under investigation in adults.

In this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults:

Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23
PCV7, 4-month interval, PPV23
PPV23

We aim to:

compare the safety profiles of pneumococcal vaccines given on each of the three schedules
compare serotype-specific ELISA antibody response to pneumococcal antigens given on each of the three schedules
compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules
study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens

Eligibility

Ages Eligible for Study:	50 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164411

Locations

United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Centers for Disease Control and Prevention

Emory University

Investigators

Principal Investigator:

Harry L Keyserling, MD

Emory University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00164411 History of Changes
Other Study ID Numbers:	CDC-NIP-3669
Study First Received:	September 9, 2005
Last Updated:	November 16, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:

Diptheria-Tetanus vaccine
Pneumococcal vaccine
Adverse events following vaccination
Immunization
Immunogenicity

Additional relevant MeSH terms:

Diphtheria
Pneumococcal Infections
Tetanus
Corynebacterium Infections
Actinomycetales Infections

Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Clostridium Infections

ClinicalTrials.gov processed this record on February 09, 2012