Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

Wyeth is now a wholly owned subsidiary of Pfizer225 enrolled

Overview

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

225

Conditions

Vaccines, Pneumococcal

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 42 DaysMax age: 98 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone * Able to complete three blood draws during study * At least 3.5 kg at enrollment Exclusion Criteria: * Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines * Immune deficiency, bleeding disorder or significant chronic medical condition

Locations (9)

Unnamed facility

Guadalajara, Jalisco, Mexico

Unnamed facility

Distrio Federal, Mexico, Mexico

Unnamed facility

Distrio Federal, Mexico, Mexico

Unnamed facility

Morelia, Michoacán, Mexico

Outcomes

Primary Outcomes

Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% 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. Exact 2-sided CI based on the observed proportion of participants.

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

Secondary Outcomes

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series

Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% 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. Exact 2-sided CI based on the observed proportion of participants.

Time frame: 1 month after dose 2 of the infant series (5 months of age)

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose

Time frame: 1 month after the toddler dose (13 months of age)

Data from ClinicalTrials.gov

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