A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

Study Overview
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Brief Summary
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This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

Official Title
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A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

Conditions
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Pneumococcal Infection

Intervention / Treatment
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* Biological: 7-valent Pneumococcal Conjugate Vaccine
* Biological: 13-valent Pnumococcal Conjugate vaccine
* Biological: 13-valent Pnumococcal Conjugate vaccine
* Biological: 13-valent Pnumococcal Conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 42 to 77 days (approximately 2 months) at the time of enrollment. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal vaccine. A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with pneumococcal vaccines.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 77 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7vPnC (3-, 4-, 5-, 12-Month)<br> | Biological: 7-valent Pneumococcal Conjugate Vaccine<br>* suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively<br>* Other names: 7vPnC;|
| Experimental: 13vPnC (3-, 4-, 5-, 12-Month)<br> | Biological: 13-valent Pnumococcal Conjugate vaccine<br>* suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively<br>* Other names: 13vPnC;|
| Experimental: 13vPnC (2-, 4-, 6-, 12-Month)<br> | Biological: 13-valent Pnumococcal Conjugate vaccine<br>* suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively<br>* Other names: 13vPnC;|
| Experimental: 13vPnC (3-, 5-, 12-Month)<br> | Biological: 13-valent Pnumococcal Conjugate vaccine<br>* suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively<br>* Other names: 13vPnC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2. |  | 1 month after the infant series (6 Months of age) | 
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3. |  | 1 month after the infant series (7 Months of age) | 
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2. |  | 1 month after the infant series (6 Months of age) | 
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3. |  | 1 month after the infant series (7 Months of age) | 
| Percentage of Participants Reporting Adverse Events in Group 1 and Group 2. |  | Approximately 16 months from the participation into the study to the end of study | 
| Percentage of Participants Reporting Adverse Events in Group 3 and Group 4. |  | Approximately 16 months from the participation into study to the end of study | 
| Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2. |  | Seven days after each pneumococcal vaccination dose within the period up to 12 months | 
| Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4. |  | Seven days after each pneumococcal vaccination dose within the period up to 12 months | 
| Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2. |  | Seven days after each pneumococcal vaccination dose within the period up to 12 months | 
| Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4. |  | Seven days after each pneumococcal vaccination dose within the period up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2. |  | 1 month after the infant series (6 Months of age) | 
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3. |  | 1 month after the infant series (7 Months of age) | 
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2. |  | 1 month after the infant series (6 Months of age) | 
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3. |  | 1 month after the infant series (7 Months of age) | 
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3. |  | 1 month after the toddler dose (13 Months of age) | 
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3. |  | 1 month after the toddler dose (13 Months of age) | 
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3. |  | 1 month after the toddler dose (13 Months of age) | 
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4. |  | 1 month after the infant series (6 Months of age) | 
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4. |  | 1 month after the infant series (6 Months of age) | 
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4. |  | 1 month after the toddler dose (13 Months of age) | 
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4. |  | 1 month after the infant series (6 Months of age) | 
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4. |  | 1 month after the toddler dose (13 Months of age) | 
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4. |  | 1 month after the infant series (6 Months of age) | 
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4. |  | 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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13vPnC, 7vPnC, Healthy subjects, China