The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
936
Huaiyin District Center for Disease Prevention and Control
Huaian, Jiangsu, China
Guanyun County Disease Control and Prevention
Lianyungang, Jiangsu, China
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Time frame: Within 7 Days After Each Vaccination
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Time frame: Within 7 Days After Each Vaccination
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
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Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.
Time frame: Within 7 Days After Each Vaccination
Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Time frame: From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.
Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.
Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
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 considered to be an important medical event.
Time frame: From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last 13vPnC vaccination in each of the 3 cohorts. GMT and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken before vaccination and 1 month after vaccination in each of the 3 cohorts. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Time frame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of approximately 50 participants receiving 13vPnC and approximately 25 participants receiving Hib vaccine from the blood samples taken before vaccination and 1 month after the last 13vPnC vaccination in each of the 3 cohorts.
Time frame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose of vaccination (13vPnC or Hib vaccine) in Cohorts 2, 3, 4.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last vaccination (13vPnC or Hib vaccine) in each of the 3 cohorts.
Time frame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Time frame: From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.
Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1
Number of Participants With NDCMCs from 1 month after vaccination 3 to vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month after Vaccination 3 to Vaccination 4.
Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1
Number of Participants With AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1. An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Time frame: From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.
Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1
Number of Participants With NDCMCs from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.
Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1
Number of Participants With SAEs from the signing of the ICD to 6 months after vaccination 4. 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 considered to be an important medical event.
Time frame: From the Signing of the ICD to 6 Months After the Vaccination 4.
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken after last vaccination in Cohort 1. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Time frame: Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1