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

NCT00676091 | Completed Phase 3 Results

• 1 other identifier: 6096A1-012
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 4

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.

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Keywords

Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (2)

• 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 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)

Other Outcomes (8)

• Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)

  Within 4 days after dose 1 (2 months of age)

• Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)

  Within 4 days after dose 2 (4 months of age)

• Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)

  Within 4 days after dose 3 (6 months of age)

Study Arms (2)

13vPnC

EXPERIMENTAL

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).

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

7vPnC

ACTIVE COMPARATOR

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).

Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Interventions

13-Valent Pneumococcal Conjugate Vaccine (13vPnC) BIOLOGICAL

13vPnC

7-Valent Pneumococcal Conjugate Vaccine (7vPnc) BIOLOGICAL

7vPnC

Eligibility Criteria

• Age: 28 Days - 54 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (4)

Unknown Facility

Curitiba, 80060-900, Brazil

Location

Unknown Facility

Florianópolis, 88025-301, Brazil

Location

Unknown Facility

Sau Paulo, 04020-060, Brazil

Location

Unknown Facility

Sau Paulo, 04038-001, Brazil

Location

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: May 12, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 8, 2011
• Results First Posted: October 15, 2010

Record last verified: 2011-08

Locations

BR (4)