A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
NCT03313050
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
- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration
- Stage 1: Vaccination within 12 months before investigational product administration
with diphtheria-, pertussis-, or tetanus-containing vaccine
- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
dose of Prevnar 13
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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 Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age | ||||||
Official Title ICMJE | A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE | ||||||
Brief Summary | This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 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). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: Observer-blinded 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 | 511 | ||||||
Original Estimated Enrollment ICMJE | 506 | ||||||
Actual Study Completion Date ICMJE | May 24, 2019 | ||||||
Actual Primary Completion Date | May 24, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 50 Years to 85 Years (Adult, Older 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 | NCT03313050 | ||||||
Other Study ID Numbers ICMJE | C3571001 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |