Phase 4
N=321
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT01250756 ↗Enrolled (actual)
321
Serious AEs
3.0%
Results posted
Feb 2013
Primary outcome: Primary: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series — 100.0; 100.0; 100.0; 100.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 7-pneumococcal conjugate vaccine (7vPnC) (Biological); diphtheria, tetanus, and acellular pertussis vaccine (DTaP) (Biological); DTaP (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series |
1.38; 0.99; 1.91; 2.05 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series |
76.79; 83.56; 72.89; 77.85 | — |
| PRIMARY 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 |
100.0; 99.2; 100.0; 99.2; 99.2; 97.7 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series |
11.82; 4.23; 5.96; 16.61; 5.48; 8.85 | — |
| SECONDARY Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose |
2.56; 2.14; 2.53; 3.04 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose |
106.54; 130.62; 120.99; 145.38 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose |
100.0; 100.0; 100.0; 100.0; 99.2; 99.2 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose |
12.15; 10.66; 6.43; 15.83; 6.53; 9.70 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose |
6.74; 5.89; 4.34; 3.63; 6.90; 6.37 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 |
100.0; 99.3; 100.0; 100.0; 99.3; 100.0 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 |
6.63; 4.30; 3.48; 11.55; 3.10; 5.16 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01250756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.