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

Wyeth is now a wholly owned subsidiary of Pfizer354 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

354

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Interventions

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)BIOLOGICAL

7-Valent Pneumococcal Conjugate Vaccine (7vPnc)BIOLOGICAL

Eligibility

Sex: ALLMin age: 28 DaysMax age: 54 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Curitiba, Brazil

Unnamed facility

Florianópolis, Brazil

Unnamed facility

Sau Paulo, Brazil

Unnamed facility

Sau Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 month after the infant series (7 months of age)

Secondary Outcomes

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)

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.

Data from ClinicalTrials.gov

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