E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of disease caused by a type of bacteria called Streptococcus pneumoniae (pneumococcal disease). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the serotype-specific pneumococcal immune responses induced by Prevenar when measured 1 month after the last dose of Prevenar in each age group.
To assess the pre-vaccination antibody levels to the 7 pneumococcal serotypes in Prevenar in each age group.
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E.2.2 | Secondary objectives of the trial |
To assess the serotype-specific pneumococcal immune responses induced by Prevenar when measured as follows: 1 month after the third dose of Prevenar in Group 1, 1 month after the second dose of Prevenar in Group 2, 1 month after the first dose of Prevenar in Group 3.
To assess the antibody levels to the 7 pneumococcal vaccine serotypes 12 months after the last dose of Prevenar in each age group.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Evidence of a personally signed and dated informed consent document indicating that the parent/legal guardian has been informed of all pertinent aspects of the study.
2. Parent/legal guardian willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Chinese male or female subject.
4. Aged 121 days to less than (<) 72 months at the time of enrollment.
5. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
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E.4 | Principal exclusion criteria |
1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7. Receipt of blood products or gamma-globulin within 12 weeks before the first dose of Prevenar until the blood draw approximately 1 month after the last dose of Prevenar.
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure (including febrile seizure for
groups 1, 2, and 3), or significant stable or evolving disorders such as cerebral palsy,
encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving
syndromes due to birth trauma, such as Erb’s palsy.
10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
11. Receipt of any investigational drugs or medical devices within 28 days before the first
dose of Prevenar until the blood draw approximately 1 month after the last dose of
Prevenar.
12. Direct descendent (child or grandchild) of any study personnel or Pfizer employee.
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar-1 month after last dose in each group
2) Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group- Baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) 1 month after last dose in each group
2) Baseline |
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E.5.2 | Secondary end point(s) |
1 month after third dose of Prevenar in Group 1
- Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Pre-vaccination to 1 month after third dose of Prevenar in Group 1
-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
1 month after second dose of Prevenar in Group 2
- Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Pre-vaccination to 1 month after second dose of Prevenar in Group 2
-GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
1 month after first dose of Prevenar in Group 3
-Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Pre-vaccination to 1 month after first dose of Prevenar in Group 3
-GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3
12 months after the last dose
-Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose
Pre-vaccination to 12 months after the last dose
-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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 month after third dose of Prevenar in Group 1
Pre-vaccination to 1 month after third dose of Prevenar in Group 1
1 month after second dose of Prevenar in Group 2
Pre-vaccination to 1 month after second dose of Prevenar in Group 2
1 month after first dose of Prevenar in Group 3
Pre-vaccination to 1 month after first dose of Prevenar in Group 3
12 months after the last dose
Pre-vaccination to 12 months after the last dose |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 17 |