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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Brazil

Conditions
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Vaccines, Pneumococcal Conjugate Vaccine

Intervention / Treatment
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* Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
* Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 54 Days

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 13vPnC<br>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)<br> <br> |
| Active Comparator: 7vPnC<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 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. | 1 month after the toddler dose (13 months of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal conjugate vaccine