Pneumococcal InfectionsPhase 1NCT00164411
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine
A Phase 1 study testing Tetanus-diphtheria toxoids (Td), 7-valent pneumococcal conjugate vaccine and 23-valent polysaccharide vaccine in people with Pneumococcal Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Tetanus-diphtheria toxoids (Td), 7-valent pneumococcal conjugate vaccine and 23-valent polysaccharide vaccine
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Current receipt of therapy for neoplastic disease
- Current receipt of immunosuppressive therapy
- Terminal illness withlife expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine
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.
Read the 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
- Conditions
- Pneumococcal Infections
- Being tested
- Tetanus-diphtheria toxoids (Td), 7-valent pneumococcal conjugate vaccine, 23-valent polysaccharide vaccine
- Keywords
- Diptheria-Tetanus vaccine, Pneumococcal vaccine, Adverse events following vaccination, Immunization, Immunogenicity
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus-diphtheria toxoids (Td)Biological
7-valent pneumococcal conjugate vaccineBiological
23-valent polysaccharide vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Emory University
- Investigators
- Harry L Keyserling, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164411
- Sponsor's protocol ID
- CDC-NIP-3669
- Status last verified
- Mar 2012
- First submitted
- 9 Sep 2005
- Last updated
- 14 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine
- ClinicalTrials.gov ID
- NCT00164411
- Acronym / sponsor ID
- CDC-NIP-3669
- Conditions
- Pneumococcal Infections
- Keywords
- Diptheria-Tetanus vaccine, Pneumococcal vaccine, Adverse events following vaccination, Immunization, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Emory University
- Study start
- Jan 2004
- Study completion
- Mar 2005
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus-diphtheria toxoids (Td) | Biological | – |
| 7-valent pneumococcal conjugate vaccine | Biological | – |
| 23-valent polysaccharide vaccine | Biological | – |
Primary outcome
ELISA for S. pneumoniae antibody 2 months after receiving PPV23
Functional S. pneumoniae antibody 2 months after receiving PPV23
1 secondary outcome
Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry L Keyserling, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetanus-diphtheria toxoids (Td), 7-valent pneumococcal conjugate vaccine and 23-valent polysaccharide vaccine in people with Pneumococcal Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ELISA for S. pneumoniae antibody 2 months after receiving PPV23. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.