Phase 4
N=506
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01193582 ↗Enrolled (actual)
506
Serious AEs
0.4%
Results posted
Nov 2013
Primary outcome: Primary: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar — 6.90; 7.16; 7.53; 9.45 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prevenar (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar |
6.90; 7.16; 7.53; 9.45; 8.01; 5.79 | — |
| PRIMARY Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group |
0.01; 0.01; 0.02; 0.06; 0.12; 0.16 | — |
| SECONDARY Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1 |
6.38; 2.88; 4.18; 11.16; 4.60; 3.60 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1. |
453.17; 23.10; 43.38; 69.90; 106.74; 32.52 | — |
| SECONDARY Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2 |
8.46; 2.67; 4.71; 8.05; 4.93; 3.03 | — |
| SECONDARY GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2. |
705.95; 16.64; 44.72; 217.21; 317.90; 33.66 | — |
| SECONDARY Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3 |
8.44; 1.92; 4.77; 3.37; 5.72; 1.96 | — |
| SECONDARY GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3. |
476.49; 7.06; 28.11; 108.18; 236.39; 15.13 | — |
| SECONDARY Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose. |
0.78; 0.65; 0.96; 1.27; 3.22; 2.31 | — |
| SECONDARY GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose. |
52.86; 50.54; 52.19; 21.01; 25.52; 15.58 | — |
Summary
A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.
This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.
Eligibility Criteria
Inclusion Criteria
- Healthy Chinese male or female subjects.
- Between 121 days to less than 72 months of age at the time of entry into the study.
Exclusion Criteria
- Receipt of previous vaccine against Pneumo
- Previous anaphylactic reaction to any vaccine or part of a vaccine
- Previous proven invasive Pneumo infection
- Receipt of investigational drug or device within the proceeding 28 days
Data sourced from ClinicalTrials.gov (NCT01193582). 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.