A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years
NCT02955160
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
1. Male or female adults 18 to 49 years of age.
2. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study.
3. Negative serum pregnancy test for all female subjects who are of childbearing potential.
1. Baseline laboratory test results outside of the normal reference range considered
clinically significant.
2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
associated with a vaccine.
3. History of culture-proven invasive disease caused by S pneumoniae.
4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.
5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12
months before investigational product administration, or planned receipt through study
participation.
6. Male subjects and female subjects of childbearing potential who are unwilling or
unable to use a highly effective method of contraception as outlined in this protocol
for the duration of the study participation and for at least 6 months after the last
dose of investigational product.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Kelowna, British Columbia
- Vancouver, British Columbia
- Vancouver, British Columbia
- Winnipeg, Manitoba
- Windsor, New Brunswick
- Halifax, Nova Scotia
- Hamilton, Ontario
- London, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Windsor, Ontario
- Montreal, Quebec
- Sherbrooke, Quebec
- Ste-Foy, Quebec
- Clermont-ferrand,
- Issoire,
- Marseille,
- Marseille,
- Marseille,
- Menton,
- Nice,
- Orange,
- Paris,
- Paris,
- Paris,
- Paris,
- Paris,
- Saint-denis,
- Vaison-la-romaine,
- Valreas,
- Vichy,
- Monaco,
- Sector-12, Chandigarh
- Sector-32 B, Chandigarh
- Bangalore, Karnataka
- Bangalore, Karnataka
- Mumbai, Maharashtra
- Pune, Maharashtra
- Pune, Maharashtra
- Pune, Maharashtra
- Rajinder Nagar, New Delhi
- Ludhiana, Punjab
- Chennai, Tamil Nadu
- Vellore, Tamil Nadu
- Seoul,
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years | |||
| Official Title ICMJE | A Phase 1, Randomized, Controlled, Observer-blinded Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults Aged 18 To 49 Years | |||
| Brief Summary | This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention | |||
| Condition ICMJE | Pneumococcal Infections | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 66 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 1, 2017 | |||
| Actual Primary Completion Date | August 1, 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 49 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02955160 | |||
| Other Study ID Numbers ICMJE | B7471001 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||