AgedPhase 4NCT00964769
Study of Evaluation Indexes for Antibody Production in Sera After Immunization
A Phase 4 study testing pneumococcal polysaccharide vaccine in people with Aged, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in… Read more about this study
- Who is it for?
- Ages 2 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- pneumococcal polysaccharide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2005to Jun 2005
- Phase
- Phase 4
- 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 2 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- elderly subjects over the age 65 years who had not received pneumococcal vaccination
- adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)
- children subjects over the age of 2 years with no previous history of pneumococcal vaccination
Who cannot join
- immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ewha Womans University Dongdaemun Hospital
Seoul, Seoul, 110-125
About this study
Official title: A Study of Evaluation Indexes for Antibody Production in Sera After Immunization
The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.
Read the detailed description
To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
- Conditions
- Aged
- Being tested
- pneumococcal polysaccharide vaccine
- Keywords
- Pneumococcal Vaccine, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcal polysaccharide vaccineBiological
Also called Pneumo23®
single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal polysaccharide vaccine | Experimental | The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly. Receives: Biological: pneumococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.
Measured: 1 month after vaccination
Secondary outcomes (1)
Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startApr 2005
- Primary completionMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgedStudies 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 4
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Hyo Kim, Doctor, Principal investigator, Ewha Womans University Dongdaemun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964769
- Sponsor's protocol ID
- EU-KF-05092341
- Other IDs
- 05092KFDA341
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee H, Nahm MH, Kim KH. The effect of age on the response to the pneumococcal polysaccharide vaccine. BMC Infect Dis. 2010 Mar 10;10:60. doi: 10.1186/1471-2334-10-60.
PubMed 20219110
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Evaluation Indexes for Antibody Production in Sera After Immunization
- ClinicalTrials.gov ID
- NCT00964769
- Acronym / sponsor ID
- EU-KF-05092341
- Conditions
- Aged
- Keywords
- Pneumococcal Vaccine, Aged
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 25 Aug 2009 (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 aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.
Detailed description
To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal polysaccharide vaccine | Experimental | Biological: pneumococcal polysaccharide vaccineThe immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly. |
Who may qualify
- Ages
- 2 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- elderly subjects over the age 65 years who had not received pneumococcal vaccination
- adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)
- children subjects over the age of 2 years with no previous history of pneumococcal vaccination
Key exclusion criteria (1 listed)
- immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine
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 |
|---|---|---|
| pneumococcal polysaccharide vaccineAlso: Pneumo23®single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France) | Biological | Pneumococcal polysaccharide vaccine |
Primary outcome
Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.
Time frame: 1 month after vaccination
1 secondary outcome
Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)
Time frame: 1 month after 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 25 Aug 2009.
- Derived from this study: PubMed 20219110Lee H, Nahm MH, Kim KH. The effect of age on the response to the pneumococcal polysaccharide vaccine. BMC Infect Dis. 2010 Mar 10;10:60. doi: 10.1186/1471-2334-10-60.
Related trials for Aged
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
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.
Kyung-Hyo Kim, Doctor principal investigator
Ewha Womans University Dongdaemun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pneumococcal polysaccharide vaccine in people with Aged, run by Ewha Womans University at 1 site in South Korea.
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 3 inclusion and 1 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 25 Aug 2009. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly. (time frame: 1 month after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00964769, which also lists 1 linked publication.
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 25 Aug 2009.