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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001174-34 | EudraCT Number |
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This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent Pneumococcal conjugate vaccine | Biological | 1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state. | Within 1 month after 13vPnC vaccination |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Before 13vPnC vaccination |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. |
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Inclusion Criteria:
Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.
Exclusion Criteria:
Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King George Hospital | Visakhapatnam | Andhra Pradesh | 530002 | India | ||
| B. J. Medical College & Civil Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28881165 | Derived | Solanki BB, Juergens C, Chopada MB, Supe P, Sundaraiyer V, Le Dren-Narayanin N, Cutler MW, Gruber WC, Scott DA, Schmoele-Thoma B. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial. Hum Vaccin Immunother. 2017 Sep 2;13(9):2065-2071. doi: 10.1080/21645515.2017.1331796. | |
| 28719496 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 1200 (200 pediatric and 1000 adult) participants were randomized in the study. Out of the 1000 adult participants, 999 participants and all 200 pediatric participants received vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC (Pediatric Participants) | Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly. |
| FG001 | 13vPnC (Adult Participants) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Blood sample collection | Procedure | 10 mL of blood will be collected just before and approximately 1 month after vaccination. |
|
| 1 month after 13vPnC vaccination |
| Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Before 13vPnC vaccination, 1 month after 13vPnC vaccination |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Before 13vPnC vaccination |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | 1 month after 13vPnC vaccination |
| Ahmedabad |
| Gujarat |
| 380016 |
| India |
| S.B.K.S Medical Institute & Research Centre | Vadodara | Gujarat | 391760 | India |
| M.S. Ramaiah Cliical Research Centre, M.S. Ramaiah Medical College & Hospitals | Bangalore | Karnataka | 560054 | India |
| M.S. Ramaiah Medical College and Hospitals | Bangalore | Karnataka | 560054 | India |
| Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd. | Hubli | Karnataka | 580021 | India |
| Cheluvamba Hospital | Mysore | Karnataka | 570001 | India |
| Niramaya Hospital | Chinchwad Pune | Maharashtra | 411019 | India |
| Supe Heart & Diabetes Hospital and Research Centre | Nashik | Maharashtra | 422002 | India |
| Chopda Medicare and Research Centre Pvt. Ltd | Nashik | Maharashtra | 422005 | India |
| Medipoint Hospitals Pvt. Ltd. | Pune | Maharashtra | 411007 | India |
| Padmashree Dr. D. Y. Patil Medical College | Pune | Maharashtra | 411018 | India |
| Christian Medical College | Vellore | Tamil Nadu | 632 004 | India |
| Samvedna Hospital | Varanasi | Uttar Pradesh | 221005 | India |
| Bhatia Hospital | Mumbai | 400007 | India |
| Orange City Hospital and Research Institute | Nagpur | 440015 | India |
| Agarkhedkar S, Juergens C, Balasundaram K, Agarkhedkar S, Sundaraiyer V, Le Dren-Narayanin N, Cutler MW, Gruber WC, Scott DA, Schmoele-Thoma B; B1851140 Study Team. Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Children 6-17 Years of Age in India: An Open-label Trial. Pediatr Infect Dis J. 2017 Nov;36(11):e283-e285. doi: 10.1097/INF.0000000000001695. |
Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
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| NOT COMPLETED |
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Safety population included all participants who received 1 dose of 13vPnC vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC (Pediatric Participants) | Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly. |
| BG001 | 13vPnC (Adult Participants) | Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly. |
| BG002 | 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, Customized | Number | Participants |
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| Sex: Female, Male | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state. | Safety population included all participants who received 1 dose of 13vPnC vaccination. | Posted | Number | Percentage of participants | Within 1 month after 13vPnC vaccination |
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| Primary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination | Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before 13vPnC vaccination |
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| Primary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination | Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month after 13vPnC vaccination |
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| Primary | Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination | GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | Before 13vPnC vaccination, 1 month after 13vPnC vaccination |
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| Primary | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination | Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | Before 13vPnC vaccination |
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| Primary | Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination | Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 month after 13vPnC vaccination |
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Baseline to 1 month after 13vPnC vaccination (up to 42 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC (Pediatric Participants) | Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly. | 0 | 200 | 0 | 200 | ||
| EG001 | 13vPnC (Adult Participants) | Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly. | 0 | 999 | 70 | 999 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Vaccination site pain | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Vaccination site erythema | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Vaccination site nodule | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Vaccination site induration | General disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
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Restriction Description: 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 |
| Title | Measurements |
|---|---|
|
| 50 to 64 years |
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| 65 to 84 years |
|
| Male |
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Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
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Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
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Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
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| 13vPnC (Adult Participants) |
Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly. |
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| 13vPnC (Adult Participants) |
Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly. |
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