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

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676091
• Other study ID #: 6096A1-012
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2008
• Last updated: August 4, 2011
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 54 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological:
• 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

• 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 Month after the infant series (7 Months of age)	No
Primary	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	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.	1 month after the infant series (7 months of age)	No
Secondary	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	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.	1 month after the toddler dose (13 months of age)	No
Secondary	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	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.	1 month after the toddler dose (13 months of age)	No