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 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061353 |
E.1.2 | Term | Pneumococcal infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 demonstrate that the immune responses to the 13 pneumococcal serotypes induced by 13vPnC in a 3-, 4-, 5-, and 12-month schedule (Group 2) are noninferior to the immune responses induced by 7vPnC in a 3-, 4-, 5-, and 12-month schedule (Group 1) when measured 1 month after the infant series.
To demonstrate that the immune responses to the 13 pneumococcal serotypes induced by 13vPnC in a 2-, 4-, 6-, and 12-month schedule (Group 3) are noninferior to the immune responses induced by 7vPnC in a 3-, 4-, 5-, and 12-month schedule (Group 1) when measured 1 month after the infant series.
To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
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E.2.2 | Secondary objectives of the trial |
To evaluate the immune responses (IRs) to:
1) 13 pneumococcal serotypes induced by 13vPnC in a 3, 4, 5, and 12 month (mo) schedule (Group 2) compared to the IRs induced by 7vPnC in a 3, 4, 5, and 12 mo (Group 1) schedule when measured 1 mo after the toddler dose (td).
2) 13 pneumococcal serotypes induced by 13vPnC in a 2, 4, 6 and 12 mo schedule (Group 3) compared to the IRs induced by 7vPnC in a 3, 4, 5, and 12 mo schedule (Group 1) when measured 1 mo after the td.
3) 13 pneumococcal serotypes induced by 13vPnC in a 3, 5, and 12 mo schedule (Group 4) compared with the IRs induced by 7vPnC in a 3, 4, 5, and 12 mo schedule (Group 1) when measured 1 mo after the infant series and 1 mo after the td.
4) To describe the IRs to the 13 pneumococcal serotypes induced by 13vPnC in a 3, 4, 5, and 12 mo schedule (Group 2), 13vPnC in a 2, 4, 6, and 12 mo schedule (Group 3), and 13vPnC in a 3, 5, and 12 mo schedule (Group 4) when measured 1 mo after the infant series and 1 mo after the td. |
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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 subject’s parent/legal guardian has been informed of all pertinent aspects of the study.
2. Subject’s caregiver willing and able to comply with scheduled visits, laboratory tests, and other study procedures. The subject’s caregiver must be able to be reached by telephone for the duration of the study.
3. Male or female subject aged 42 to 77 days (approximately 2 months) at the time of enrollment.
4. Healthy infant 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. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccines.
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. Major known congenital malformation or serious chronic disorder.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Resolving syndromes due to birth trauma such as perception before Brachial plexus birth palsy (Erb palsy) not included.
9. Receipt of blood products or gamma globulin. Hepatitis B immunoglobulin might be given.
10. Participation in another investigational trial within 28 days before the current study begins and during study participation. Participation in purely observational studies acceptable
11. Subjects whose parents or legal guardian are investigational site staff members or subjects whose parents or legal guardian are Pfizer employees directly involved in the conduct of the trial.
12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, made the subject inappropriate for entry into this study
13. Known or suspected allergy to 13vPnC, 7vPnC, or other compounds related to these classes of medication.
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to 0.35 microgram per millilitre (mcg/mL) 1 Month After the Infant Series: Group 1, 2 and 3 Subjects.
2) Serotype-specific IgG Geometric Mean Concentrations (GMCs) 1 Month After Infant Series: Group 1, 2 and 3 Subjects.
3) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 1 - Infant Series.
4) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 2 – Infant Series.
5) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 3 – Infant Series.
6) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 4 – Toddler Dose.
7) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 1 – Infant Series
8) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 2 – Infant Series.
9) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 3 – Infant Series.
10) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 4 – Toddler Dose.
11) Percentage of Participants Reporting Adverse Events |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) 1 month after the infant series
2) 1 Month After Infant Series
3) Within 7 Days After Vaccination 1
4) Within 7 Days After Vaccination 2
5) Within 7 Days After Vaccination 3
6) Within 7 Days After Vaccination 4
7) Within 7 Days After Vaccination 1
8) Within 7 Days After Vaccination 2
9) Within 7 Days After Vaccination 3
10) Within 7 Days After Vaccination 4
11) Baseline up to Month 18 |
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E.5.2 | Secondary end point(s) |
1) Percentage of Subjects Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series: Group 1, 2, 3 and 4 Subjects.
2) Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series: Group 1, 2, 3 and 4 Subjects.
3) Serotype-specific IgG Geometric Mean Concentrations (GMCs) 1 Month After Toddler Dose: Group 1, 2, 3 and 4 Subjects.
4) Percentage of Subjects Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 1, 2, 3 and 4 Subjects.
5) Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 1, 2, 3 and 4 Subjects.
6) Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to 0.35 microgram per millilitre (mcg/mL) 1 Month After the Infant Series in Group 4 Subjects.
7) Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to 0.35 microgram per millilitre (mcg/mL) 1 Month After the Infant Series: Group 4 Subjects.
8) Serotype-specific IgG Geometric Mean Concentrations (GMCs) 1 Month After Infant Series: Group 4 Subjects.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 1 Month After Infant Series.
2) 1 Month After the Infant Series
3) 1 month after the toddler dose
4) 1 Month After Toddler Dose
5) 1 Month After the Toddler Dose
6) 1 month after the infant series
7) 1 month after the infant series
8) 1 Month After Infant Series.
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
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 | Yes |
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 | 1 |
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 | 0 |