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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-7316 | Other Identifier | WHO |
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This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment.
Primary Objective:
Secondary Objective:
All adult participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, toddler participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, infant participants will receive 3 injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose), with a safety evaluation after each dose level before the study proceeds to the next higher dose. All participants will undergo immunogenicity testing and monitoring for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Adults High Dose (Formulation 1) | Experimental | Adults who will receive a single injection of high dose investigational Pneumococcal vaccine |
|
| Group 2: Adults Placebo | Placebo Comparator | Adult participants who will receive an injection of placebo |
|
| Group 3: Toddlers High Dose (Formulation 1) | Experimental | Toddlers who will receive a single injection of high dose Pneumococcal vaccine |
|
| Group 4: Toddlers Placebo | Placebo Comparator | Toddlers who will receive a single injection of placebo |
|
| Group 5: Infants Low Dose (Formulation 2) | Experimental | Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal Vaccine High Dose (Formulation 1) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination. | Solicited injection site reactions: For adults: Pain, Erythema, and Swelling; Toddlers and infants: Tenderness, Erythema, Swelling. Solicited systemic reactions: For adults, Fever (Temperature), Headache, Malaise, and Myalgia; Toddlers and infants, Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. | Day 0 through Day 90 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of the Pneumococcal Vaccine in adults and toddlers | Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA). | Day 30 post-vaccination (adults and toddlers) |
| Immunogenicity of the Pneumococcal Vaccine in toddlers |
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Inclusion Criteria:
Adults:
Infants and Toddlers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka | 1212 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26143615 | Result | Brooks WA, Chang LJ, Sheng X, Hopfer R; PPR02 Study Team. Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study. Vaccine. 2015 Aug 26;33(36):4610-7. doi: 10.1016/j.vaccine.2015.06.078. Epub 2015 Jul 2. |
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| Group 6: Infants Placebo |
| Placebo Comparator |
Infants who will receive 3 injections of placebo |
|
| Group 7: Infants Middle Dose (Formulation 3) | Experimental | Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
|
| Group 8: Infants Middle Dose (Formulation 4) | Experimental | Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
|
| Group 9: Infants Placebo | Placebo Comparator | Infants who will receive 3 injections of placebo |
|
| Group 10: Infants High Dose (Formulation 1) | Experimental | Infants who will receive 3 injections of high dose Pneumococcal vaccine |
|
| Group 11: Infants Placebo | Placebo Comparator | Infants who will receive 3 injections of placebo |
|
| Tris buffered saline (Placebo) | Biological | 0.5 mL, Intramuscular |
|
|
| Pneumococcal Vaccine High Dose (Formulation 1) | Biological | 0.5 mL, Intramuscular |
|
| Tris buffered saline (Placebo) | Biological | 0.5 mL, Intramuscular |
|
|
| Pneumococcal Vaccine Low Dose (Formulation 2) | Biological | 0.5 mL, Intramuscular |
|
| Tris buffered saline (Placebo) | Biological | 0.5 mL, Intramuscular |
|
|
| Pneumococcal Vaccine Middle Dose (Formulation 3) | Biological | 0.5 mL, Intramuscular |
|
| Pneumococcal Vaccine Middle Dose (Formulation 4) | Biological | 0.5 mL, Intramuscular |
|
| Tris buffered saline (Placebo) | Biological | 0.5 mL, Intramuscular |
|
|
| Pneumococcal Vaccine High Dose (Formulation 1) | Biological | 0.5 mL, Intramuscular |
|
| Tris buffered saline (Placebo) | Biological | 0.5 mL, Intramuscular |
|
|
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA). |
| Day 30 post-vaccination 2 and 3 (infants) |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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