Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
NCT ID: NCT00464945
Last Updated: 2012-08-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
269 participants
INTERVENTIONAL
2007-06-30
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
2
13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion Criteria
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
41 Days
99 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Torun, Bydgoszcz, Poland
Krakow, Krakow, Poland
Krakow, Krakow, Poland
Siemianowice Śląskie, Krakow, Poland
Lubartowie, Lublin Voivodeship, Poland
Lublin, Lublin Voivodeship, Poland
Warsaw, Warszawa, Poland
Lodz, Łódź Voivodeship, Poland
Lodz, Łódź Voivodeship, Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6096A1-3000
Identifier Type: -
Identifier Source: org_study_id