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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005039-59 | EudraCT Number |
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Study vaccinations and blood draws were halted due to adequacy of a smaller dataset and study feasibility issues. It was not based on any safety concerns.
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This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Coadministration | Experimental | Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 |
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| Group 2 - Staggered Administration | Experimental | Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 |
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| Group 3 - Control with Supplemental Dose | Active Comparator | Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent | Biological | Pneumococcal conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 Days After Dose 1 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 Days After Dose 2 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 Days After Dose 3 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 | IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | 1 Month After Dose 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Pediatric Clinic | Mobile | Alabama | 36607 | United States | ||
| Harrisburg Family Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37927075 | Derived | Simon MW, Bataille R, Caldwell NS, Gessner BD, Jodar L, Lamberth E, Peng Y, Scott DA, Lei L, Giardina PC, Gruber WC, Jansen KU, Thompson A, Watson W. Safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with 13-valent pneumococcal conjugate vaccine in healthy infants: A phase 2 randomized trial. Hum Vaccin Immunother. 2023 Aug;19(2):2245727. doi: 10.1080/21645515.2023.2245727. Epub 2023 Nov 5. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 569 infants had a signed informed consent document; 4 of these infants were deemed ineligible before randomization, and did not participate further. 565 participants were randomized in 3 reporting groups- 512 participants from 39 sites and 53 from 2 terminated sites (terminated due to serious quality issues). The study includes and reports valid data only from 512 participants. Out of these 512 participants, 484 received at least 1 vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: c7vPnC and Prevnar 13 Co-administration | Participants who received a dose of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2020 | Oct 20, 2021 |
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| Prevnar 13 | Biological | Pneumococcal conjugate vaccine |
|
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). |
| Within 7 Days After Dose 4 |
| Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 Days After Supplemental Dose |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (>=) 38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days After Dose 1 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days After Dose 2 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days After Dose 3 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days After Dose 4 |
| Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days After Supplemental Dose |
| Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months) |
| Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month) |
| Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month) |
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study | An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event. | From Dose 1 to End of the Study (up to duration of 17 months) |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects. | From Dose 1 to End of the Study (up to duration of 17 months) |
| Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Percentage of participants with pre-specified IgG concentration (>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | 1 Month after Dose 3 |
| Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 | IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3. | 1 Month After Dose 4 |
| Harrisburg |
| Arkansas |
| 72432 |
| United States |
| Emmaus Research Center, Inc. | Anaheim | California | 92804 | United States |
| Hoag Memorial Hospital Presbyterian | Huntington Beach | California | 92648 | United States |
| Madera Family Medical Group | Madera | California | 93637 | United States |
| Orange County Research Institute | Ontario | California | 91762 | United States |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | United States |
| Center for Clinical Trials | Paramount | California | 90723 | United States |
| Gentle Medicine Associates | Boynton Beach | Florida | 33435 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Next Phase Research Alliance | Homestead | Florida | 33030 | United States |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | United States |
| Bio-Medical Research, LLC | Miami | Florida | 33184 | United States |
| Crystal Biomedical Research, LLC | Miami Lakes | Florida | 33014 | United States |
| IACT Health | Columbus | Georgia | 31903 | United States |
| Advocate Children's Hospital | Park Ridge | Illinois | 60068 | United States |
| MOC Research | Mishawaka | Indiana | 46544 | United States |
| Michael W. Simon, MD, PSC | Lexington | Kentucky | 40517 | United States |
| All Children Pediatrics | Louisville | Kentucky | 40243 | United States |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70806 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| LSUHSC-Shreveport | Shreveport | Louisiana | 71103 | United States |
| Ochsner-LSU Health Shreveport | Shreveport | Louisiana | 71103 | United States |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Pediatric Phlebotomy | Boston | Massachusetts | 02111 | United States |
| Tufts Medical Center IDS - Pharmacy | Boston | Massachusetts | 02111 | United States |
| Children's Mercy Clinics on Broadway | Kansas City | Missouri | 64111 | United States |
| Children's Physicians Embassy Park | Omaha | Nebraska | 68114 | United States |
| Children's Physicians Spring Valley | Omaha | Nebraska | 68117 | United States |
| Creighton University Clinical Research Office | Omaha | Nebraska | 68131 | United States |
| Child Health care Associates | East Syracuse | New York | 13057 | United States |
| Blue Ridge Pediatric and Adolescent Medicine, Inc | Boone | North Carolina | 28607 | United States |
| Sugarcamp Family Research | Dayton | Ohio | 45409 | United States |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Parkside Pediatrics | Greenville | South Carolina | 29607 | United States |
| Sanford Children's Specialty Clinic | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Research | Sioux Falls | South Dakota | 57105 | United States |
| Sanford 69th & Louise Family Medicine | Sioux Falls | South Dakota | 57108 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Ventavia Research Group | Houston | Texas | 77008 | United States |
| Mercury Clinical Research | Houston | Texas | 77054 | United States |
| Pediatric Associates | Houston | Texas | 77087 | United States |
| Ventavia Research Group | Keller | Texas | 76248 | United States |
| Tekton Research, Inc. | San Antonio | Texas | 78240 | United States |
| Ventavia Research Group, LLC | Spring | Texas | 77389 | United States |
| Dixie Pediatrics | St. George | Utah | 84790 | United States |
| Marshall Health | Huntington | West Virginia | 25701 | United States |
| Group 2: c7vPnC and Prevnar 13 Staggered Administration |
Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. |
| FG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
| Vaccinated for Dose 1 |
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| Vaccinated for Dose 2 |
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| Vaccinated for Dose 3 |
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| COMPLETED |
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| NOT COMPLETED |
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|
The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: c7vPnC and Prevnar 13 Co-administration | Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg. |
| BG001 | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. |
| BG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 1 in the overall safety population. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 1 |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after vaccination in the overall safety population. Dose 2 was second dose of c7vPnC in Group 1 and Group 2, and second dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 2 |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after vaccination in the overall safety population. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 3 |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after vaccination in the overall safety population. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 4 |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) | Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Participants received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Since supplemental dose was received by participants in reporting arm "Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose", hence data collected and reported for it only and not collected for Group 1 and 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Supplemental Dose |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (>=) 38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 1 in overall safety population. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 1 |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 2 in overall safety population. Dose 2 was second dose of c7vPnC in Group 1 and Group 2, and second dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 2 |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 3 in overall safety population. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 3 |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 4 in overall safety population. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Dose 4 |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose | Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Supplemental dose safety analysis set included participants who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Since supplemental dose was received by participants in reporting arm "Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose", hence data collected and reported for it only and not collected for Group 1 and 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days After Supplemental Dose |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | Dose 4 safety analysis set included participants who received Dose 4 and had safety data between Dose 4 and 1 month after Dose 4 for Groups 1 and 2 and had safety data between Dose 4 and Supplemental Dose for Group 3. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month) |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | Supplemental dose safety analysis set included participants who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental dose. Since supplemental dose was received by participants in reporting arm "Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose", hence data collected and reported for it only and not collected for Group 1 and 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study | An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event. | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 to End of the Study (up to duration of 17 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects. | The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 to End of the Study (up to duration of 17 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 | IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, and had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter | 1 Month After Dose 3 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | Percentage of participants with pre-specified IgG concentration (>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3. | Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 Month after Dose 3 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 | IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3. | Dose 4 evaluable immunogenicity population: eligible participants, randomly assigned to receive vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, received all 4 doses of assigned vaccine, with Dose 4 received in defined window (365-386 days of age), had valid determinate IgG concentration for at least 1 serotype 1 month post dose 4,had blood collection within 27-56 days post Dose 4, and had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter | 1 Month After Dose 4 |
|
Local reactions, systemic events: within 7 days after Dose 1, 2, 3, 4, Supplemental Dose; Non-SAEs: from Dose 1 to 1 month after Dose 3, Dose 4 to 1 month after Dose 4, Supplemental Dose to 1 month after Supplemental Dose ; SAEs: Dose 1 to 6 months after last dose (Dose 4 or Supplemental Dose) (up to duration of 17 months)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Overall safety analysis set was analyzed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: c7vPnC and Prevnar 13 Co-administration | Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg. | 0 | 171 | 7 | 171 | 163 | 171 |
| EG001 | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. | 0 | 147 | 4 | 147 | 138 | 147 |
| EG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). | 0 | 166 | 9 | 166 | 163 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Parotid abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Craniosynostosis | Congenital, familial and genetic disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Plagiocephaly | Congenital, familial and genetic disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decreased appetite (DECREASED APPETITE) | Metabolism and nutrition disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Somnolence (DROWSINESS) | Nervous system disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Irritability (IRRITABILITY) | Psychiatric disorders | MedDRA v23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2018 | Oct 20, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at Injection Site: Any |
|
| Pain at Injection Site: Mild |
|
| Pain at Injection Site: Moderate |
|
| Pain at Injection Site: Severe |
|
Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
|
|
Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
|
|
Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. |
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
|
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| OG001 | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. |
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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| OG001 | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. |
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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| OG001 | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg. |
| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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| OG002 | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose). |
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