Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Pfizer234 enrolled

Overview

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

234

Conditions

Pneumococcal Vaccines

Interventions

13vPnCBIOLOGICAL

13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.

13vPnCBIOLOGICAL

13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Eligibility

Sex: ALLMin age: 140 DaysMax age: 392 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy children previously immunized with 1 or 2 doses of Prevenar. * Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment. * Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment * Available for entire study period. Exclusion Criteria: * Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component. * Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Locations (7)

Pfizer Investigational Site

Eskilstuna, Sweden

Pfizer Investigational Site

Gothenburg, Sweden

Pfizer Investigational Site

Malmö, Sweden

Pfizer Investigational Site

Örebro, Sweden

Outcomes

Primary Outcomes

Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose

Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

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

Secondary Outcomes

Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose

Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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 the infant series (6 months of age)

GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose

Antibody GMC for 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.

Time frame: 1 Month after the infant series (6 months of age)

GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose

Antibody GMC for 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.

Data from ClinicalTrials.gov

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