Pneumococcal InfectionPhase 3NCT00496093
Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
A Phase 3 study testing Pneumococcal Vaccine, Polyvalent (23-valent) in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC.
Trial summary
To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- Pneumococcal Vaccine, Polyvalent (23-valent)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Jan 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy indian adults of 50 years of age
- In good health; any underlying chronic illness must be documented to be in stable condition
- Signed and dated informed consent prior to receipt of the study vaccine
Who cannot join
- Functional or anatomic asplenia
- History of auto immune disease
- Hypersensitivity to any of the components of the study vaccine,including phenol
- Known or suspected immune dysfunction, including persons with congenital immunodeficiency
- Prior vaccination with any pneumococcal vaccine
About this study
Official title: Safety, Tolerability and Immunogenicity of Pneumovax 23 (V110) in Healthy Adults in India
To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.
Read the detailed description
This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.
- Conditions
- Pneumococcal Infection
- Being tested
- Pneumococcal Vaccine, Polyvalent (23-valent)
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Vaccine, Polyvalent (23-valent)Biological
Also called V110, PNEUMOVAX™ 23
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal Vaccine, Polyvalent (23-valent) | Experimental | Participants received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1. Receives: Biological: Pneumococcal Vaccine, Polyvalent (23-valent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
Measured: post-vaccination
Secondary outcomes (1)
Any AE within 15 days after vaccination, with particular attention to injection site AE and fever
Measured: 15 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startOct 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496093
- Sponsor's protocol ID
- V110-011
- Other IDs
- 2007_018
- Status last verified
- Mar 2017
- First submitted
- 3 Jul 2007
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Immunogenicity of Pneumovax 23 (V110) in Healthy Adults in India
- ClinicalTrials.gov ID
- NCT00496093
- Acronym / sponsor ID
- V110-011
- Conditions
- Pneumococcal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 4 Jul 2007 (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.
To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.
Detailed description
This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal Vaccine, Polyvalent (23-valent) | Experimental | Biological: Pneumococcal Vaccine, Polyvalent (23-valent)Participants received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy indian adults of 50 years of age
- In good health; any underlying chronic illness must be documented to be in stable condition
- Signed and dated informed consent prior to receipt of the study vaccine
Key exclusion criteria (5 listed)
- Functional or anatomic asplenia
- History of auto immune disease
- Hypersensitivity to any of the components of the study vaccine,including phenol
- Known or suspected immune dysfunction, including persons with congenital immunodeficiency
- Prior vaccination with any pneumococcal 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 Vaccine, Polyvalent (23-valent)Also: V110, PNEUMOVAX™ 23 | Biological | Pneumococcal Vaccine, Polyvalent (23-valent) |
Primary outcome
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
Time frame: post-vaccination
1 secondary outcome
Any AE within 15 days after vaccination, with particular attention to injection site AE and fever
Time frame: 15 days 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 14 Mar 2017.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumococcal Vaccine, Polyvalent (23-valent) in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC.
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 5 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 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b (time frame: post-vaccination). 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 2017.