A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

Study Overview
=================
Brief Summary
-----------------
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

Official Title
-----------------
A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: 7-pneumococcal conjugate vaccine (7vPnC)
* Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
* Biological: DTaP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment. Available for entire study period and whose parent/legal guardian can be reached by telephone. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines. A previous anaphylactic reaction to any vaccine or vaccine-related component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection. History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis). Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental | Biological: 7-pneumococcal conjugate vaccine (7vPnC)<br>* 0.5 mL per dose, 4 doses<br>Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)<br>* 0.5 mL per dose, 4 doses<br>|
| Experimental: 2<br>Active comparator | Biological: DTaP<br>* 0.5 mL per dose, 4 doses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA). | 1 month after the infant series | 
| Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series | Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies. | 1 month after the infant series | 
| Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series | GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. | 1 month after the infant series | 
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants. | 1 month after the infant series | 
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | 1 month after the infant series | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA. | 1 month after the toddler dose | 
| Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies. | 1 month after the toddler dose | 
| Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. | 1 month after the toddler dose | 
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants. | 1 month after the toddler dose | 
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | 1 month after the toddler dose | 
| Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. | Pre-toddler dose, 1 month after the toddler dose | 
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 | Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants. | 1 month after the catch-up dose 3 | 
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. | 1 month after the catch-up dose 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, pneumococcal conjugate