A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)
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| ClinicalTrials.gov Identifier: NCT00127153 |
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Recruitment Status
:
Completed
First Posted
: August 5, 2005
Last Update Posted
: January 29, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief Summary:
The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Pneumococcal Infections | Biological: V110, pneumococcal vaccine polyvalent | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | March 2005 |
| Actual Primary Completion Date : | May 2005 |
| Actual Study Completion Date : | May 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pneumococcal Infections
U.S. FDA Resources
Primary Outcome Measures
:
- Immunogenicity
Secondary Outcome Measures
:
- Safety
Information from the National Library of Medicine
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| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males and females in good health, ages 20-40, with no history of pneumococcal vaccination
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127153
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00127153 History of Changes |
| Other Study ID Numbers: |
V110-013 2005_039 |
| First Posted: | August 5, 2005 Key Record Dates |
| Last Update Posted: | January 29, 2015 |
| Last Verified: | January 2015 |
Additional relevant MeSH terms:
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Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |