Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

Study Overview
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Brief Summary
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This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

Official Title
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A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

Conditions
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13-valent Pneumococcal Vaccine, Immunization, Safety, Antibody Response

Intervention / Treatment
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* Biological: 13-valent pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months Exclusion Criteria: Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678). History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678). Previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1 dose (0.5 mL), IM of 13vPnC vaccine. | Biological: 13-valent pneumococcal conjugate vaccine<br>* All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine | Antibody GMC as measured by microgram/millilitre (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) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | One month after vaccination | 
| Percentage of Participants With Prespecified Local Reactions | Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category. | Seven days after vaccination | 
| Percentage of Participants With Prespecified Systemic Events | Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category. | Seven days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine | IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Up to 7 days before vaccination | 
| Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine | IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Four to seven days after vaccination | 
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine | Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | Up to 7 days before vaccination | 
| Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine | Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | One month after vaccination | 
| Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine | Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants. | One month after vaccination | 
| Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine | Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants. | One month after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal vaccine 13-valent