Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

Phase 3

Completed

• Conditions: Vaccines, Pneumococcal Conjugate Vaccine
• Interventions: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC); Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

• Registration Number: NCT00676091
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-12
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-09-22
• Results First Submitted QC: 2010-09-22
• Results First Posted: 2010-10-15
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
13vPnC	13-Valent Pneumococcal Conjugate Vaccine (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).
7vPnC	7-Valent Pneumococcal Conjugate Vaccine (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).

Primary Outcome Measures

Name	Time	Method
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	1 Month after the infant series (7 Months of age)	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.
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	1 month after the infant series (7 months of age)	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.

Secondary Outcome Measures

Name	Time	Method
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	1 month after the toddler dose (13 months of age)	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.
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	1 month after the toddler dose (13 months of age)	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.