- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00464945
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
July 6, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine
The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
269
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Krakow, Poland, 30-663
-
Krakow, Poland, 31-442
-
Lodz, Poland, 91-347
-
Lodz, Poland, 93-338
-
Lublin, Poland, 20-044
-
Warszawa, Poland, 01-184
-
-
Bydgoszcz
-
Torun, Bydgoszcz, Poland, 87-100
-
-
Krakow
-
Siemianowice Slaskie, Krakow, Poland, 41-103
-
-
Lublin
-
Lubartowie, Lublin, Poland, 21-100
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Aged 2 months (42 to 98 days) at time of enrollment.
- Available for entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion criteria:
- Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae.
- Major known congenital malformation or serious chronic disorders.
- 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.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1 dose at 2,3,4 and 12 months of age
|
Active Comparator: 2
|
1 dose at 2,3,4 and 12 months of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Time Frame: One month after 3-dose infant series (5 months of age)
|
Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
|
One month after 3-dose infant series (5 months of age)
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Time Frame: During the 4-day period after each dose
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement).
Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
|
During the 4-day period after each dose
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Time Frame: During the 4-day period after each dose
|
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary.
Participants may be represented in more than 1 category.
|
During the 4-day period after each dose
|
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Time Frame: During the 4-day period after toddler dose
|
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary.
Participants may be represented in more than 1 category.
|
During the 4-day period after toddler dose
|
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Time Frame: One month after 3-dose infant series (5 months of age)
|
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
|
One month after 3-dose infant series (5 months of age)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
April 23, 2007
First Submitted That Met QC Criteria
April 23, 2007
First Posted (Estimate)
April 24, 2007
Study Record Updates
Last Update Posted (Estimate)
August 15, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-3000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumococcal Vaccines
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedVaccines, Pneumococcal | Vaccines, Pneumococcal Conjugate Vaccine
-
Vaxcyte, Inc.CompletedPneumococcal VaccinesUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedVaccines, PneumococcalGermany
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedPneumococcal VaccinesUnited States
-
PfizerCompletedPneumococcal Vaccines | Pneumococcal Conjugate VaccineJapan
-
VA Sierra Nevada Health Care SystemMerck Sharp & Dohme LLCNot yet recruitingImmunosuppression | Pneumococcal Vaccines
-
Maria de Lourdes de Sousa Maia, MDNot yet recruiting
-
Vaxcyte, Inc.CompletedPneumococcal VaccinesUnited States
-
Vaxcyte, Inc.Active, not recruitingPneumococcal VaccinesUnited States
-
Inventprise Inc.PATH; Canadian Center for Vaccinology; Vaccine Evaluation Center, CanadaActive, not recruitingPneumococcal VaccinesCanada
Clinical Trials on 13-valent Pneumococcal Conjugate Vaccine
-
Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdRecruitingConsistency, Immunogenicity, and Safety of Three Batches of 15-valent Pneumococcal Conjugate VaccineHealthy VolunteersChina
-
Sinovac Life Sciences Co., Ltd.RecruitingPneumococcal InfectionsChina
-
Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdNot yet recruiting
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedPneumococcal VaccineKorea, Republic of
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedVaccines, PneumococcalGermany
-
CanSino Biologics Inc.Henan Center for Disease Control and PreventionCompletedPneumococcal Infections | Bacterial Infections | Streptococcal InfectionsChina
-
Telethon Kids InstitutePapua New Guinea Institute of Medical ResearchCompleted
-
PfizerCompletedPneumococcal DiseaseSpain, Poland, Hungary
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedVaccines, PneumococcalSpain
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted