- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00474539
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
January 22, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
449
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
-
-
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Almeria, Spain, 4007
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Almeria, Spain, 4009
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Almeria, Spain, 4120
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Barcelona, Spain, 8195
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Barcelona, Spain, 8930
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Coruna, Spain, 15270
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Coruna, Spain, 15405
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Madrid, Spain, 28041
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Madrid, Spain, 28900
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Madrid, Spain, 28922
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Madrid, Spain, 28942
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Malaga, Spain, 29015
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Malaga, Spain, 29200
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Ourense, Spain, 32005
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Pamplona, Spain, 31008
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Santiago de Compostela, Spain, 15706
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Seville, Spain, 41013
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Valencia, Spain, 46008
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Valencia, Spain, 46011
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Valencia, Spain, 46021
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Valencia, Spain, 46022
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Valencia, Spain, 46023
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Valencia, Spain, 46024
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Valencia, Spain, 46183
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Valencia, Spain, 46200
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Valencia, Spain, 46930
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Vigo, Spain, 36204
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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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy 2-month-old infants
- Available for the entire study period
Exclusion criteria:
- Previous vaccination with any vaccine before the start of the study
- Known contraindication to vaccination
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 2,4,6 and 15 months of age
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Active Comparator: 2
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1 dose at 2,4,6 and 15 months of age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Time Frame: One month after infant series dose (at 5 months of age)
|
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
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One month after infant series dose (at 5 months of age)
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Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
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One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
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Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
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One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
|
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Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
|
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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.
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One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
|
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.
GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
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One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time Frame: One month after toddler dose (at 16 months of age)
|
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
|
One month after toddler dose (at 16 months of age)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Reporting Pre-Specified Local Reactions
Time Frame: During the 4-day period after each dose
|
Local reactions were collected using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement).
Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm).
Participants may be represented in more than 1 category.
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During the 4-day period after each dose
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Percentage of Participants Reporting Pre-Specified Systemic Events
Time Frame: During the 4-day period after each dose
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Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary.
Participants may be represented in more than 1 category.
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During the 4-day period after each dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For Spain: infomed@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
July 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 15, 2007
First Submitted That Met QC Criteria
May 15, 2007
First Posted (Estimate)
May 17, 2007
Study Record Updates
Last Update Posted (Estimate)
March 5, 2013
Last Update Submitted That Met QC Criteria
January 22, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-3007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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