Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
August 4, 2011 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 Routine Pediatric Vaccinations in Brazil
The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
354
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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Curitiba, Brazil, 80060-900
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Florianopolis, Brazil, 88025-301
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Sau Paulo, Brazil, 04020-060
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Sau Paulo, Brazil, 04038-001
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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
4 weeks to 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Healthy 1 month old infants
- Available for the duration of the study and reachable by telephone
- Able to complete two blood drawing procedures during the study
Exclusion criteria:
- Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
- Bleeding disorder, immune deficiency or significant chronic or congenital disease
- Previous receipt of blood products or immune globulin
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 13vPnC
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
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Active Comparator: 7vPnC
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Time Frame: 1 Month after the infant series (7 Months of age)
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Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (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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1 Month after the infant series (7 Months of age)
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Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Time Frame: 1 month after the infant series (7 months of age)
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Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.
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1 month after the infant series (7 months of age)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Time Frame: 1 month after the toddler dose (13 months of age)
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Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (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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1 month after the toddler dose (13 months of age)
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Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Time Frame: 1 month after the toddler dose (13 months of age)
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Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.
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1 month after the toddler dose (13 months of age)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Time Frame: Within 4 days after dose 1 (2 months of age)
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Pre-specified local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
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Within 4 days after dose 1 (2 months of age)
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Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Time Frame: Within 4 days after dose 2 (4 months of age)
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Pre-specified local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
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Within 4 days after dose 2 (4 months of age)
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Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Time Frame: Within 4 days after dose 3 (6 months of age)
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Pre-specified local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
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Within 4 days after dose 3 (6 months of age)
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Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Time Frame: Within 4 days after toddler dose (12 months of age)
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Pre-specified local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
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Within 4 days after toddler dose (12 months of age)
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Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Time Frame: Within 4 days after dose 1 (2 months of age)
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Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 4 days after dose 1 (2 months of age)
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Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Time Frame: Within 4 days after dose 2 (4 months of age)
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Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 4 days after dose 2 (4 months of age)
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Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Time Frame: Within 4 days after dose 3 (6 months of age)
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Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 4 days after dose 3 (6 months of age)
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Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Time Frame: Within 4 days after toddler dose (12 months of age)
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Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 4 days after toddler dose (12 months of age)
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Collaborators and Investigators
This is where you will find people and organizations involved with this 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
April 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
April 8, 2008
First Submitted That Met QC Criteria
May 7, 2008
First Posted (Estimate)
May 12, 2008
Study Record Updates
Last Update Posted (Estimate)
August 8, 2011
Last Update Submitted That Met QC Criteria
August 4, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-012
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
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