HealthyPhase 3NCT00127153
A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)
A Phase 3 study testing V110, pneumococcal vaccine polyvalent in people with Healthy and Pneumococcal Infections, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pneumococcal Infections
- What is being tested?
- V110, pneumococcal vaccine polyvalent
- Type of treatment
- Vaccines
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to May 2005
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females in good health, ages 20-40, with no history of pneumococcal vaccination
Who cannot join
- Subjects with a recent febrile illness
- Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy
About this study
Official title: A Comparative Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of V110 Formulated With Either All New Process Polysaccharides or All Current Process Polysaccharides
The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.
- Conditions
- Healthy, Pneumococcal Infections
- Being tested
- V110, pneumococcal vaccine polyvalent
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V110, pneumococcal vaccine polyvalentBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 130 participants
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
- NCT00127153
- Sponsor's protocol ID
- V110-013
- Other IDs
- 2005_039
- Status last verified
- Jan 2015
- First submitted
- 2 Aug 2005
- Last updated
- 29 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of V110 Formulated With Either All New Process Polysaccharides or All Current Process Polysaccharides
- ClinicalTrials.gov ID
- NCT00127153
- Acronym / sponsor ID
- V110-013
- Conditions
- Healthy, Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 5 Aug 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 trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females in good health, ages 20-40, with no history of pneumococcal vaccination
Key exclusion criteria (2 listed)
- Subjects with a recent febrile illness
- Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy
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 |
|---|---|---|
| V110, pneumococcal vaccine polyvalent | Biological | – |
Primary outcome
Immunogenicity
1 secondary outcome
Safety
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 29 Jan 2015.
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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 V110, pneumococcal vaccine polyvalent in people with Healthy and Pneumococcal Infections, 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 1 inclusion and 2 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 29 Jan 2015. 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?
Immunogenicity. 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 29 Jan 2015.