Back to resultsA Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
Primary Purpose
Pneumococcal Infection
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
7-valent Pneumococcal Conjugate Vaccine
13-valent Pnumococcal Conjugate vaccine
13-valent Pnumococcal Conjugate vaccine
13-valent Pnumococcal Conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infection focused on measuring 13vPnC, 7vPnC, Healthy subjects, China
Eligibility Criteria
Inclusion Criteria:
- Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccines.
Sites / Locations
- Jiangsu Province Guanyun County Center for Disease prevention and Control
- Jiangsu Province Hongze County Center for Disease prevention and Control
- Jiangsu Province Huaiyin District Center for Disease prevention and Control
- Jiangsu Province Lianshui County Center for Disease prevention and Control
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
7vPnC (3-, 4-, 5-, 12-Month)
13vPnC (3-, 4-, 5-, 12-Month)
13vPnC (2-, 4-, 6-, 12-Month)
13vPnC (3-, 5-, 12-Month)
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Secondary Outcome Measures
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01692886
Brief Title
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
Official Title
A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infection
Keywords
13vPnC, 7vPnC, Healthy subjects, China
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1674 (Actual)
8. Arms, Groups, and Interventions
Arm Title
7vPnC (3-, 4-, 5-, 12-Month)
Arm Type
Active Comparator
Arm Title
13vPnC (3-, 4-, 5-, 12-Month)
Arm Type
Experimental
Arm Title
13vPnC (2-, 4-, 6-, 12-Month)
Arm Type
Experimental
Arm Title
13vPnC (3-, 5-, 12-Month)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
7-valent Pneumococcal Conjugate Vaccine
Other Intervention Name(s)
7vPnC
Intervention Description
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Intervention Type
Biological
Intervention Name(s)
13-valent Pnumococcal Conjugate vaccine
Other Intervention Name(s)
13vPnC
Intervention Description
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Intervention Type
Biological
Intervention Name(s)
13-valent Pnumococcal Conjugate vaccine
Other Intervention Name(s)
13vPnC
Intervention Description
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
Intervention Type
Biological
Intervention Name(s)
13-valent Pnumococcal Conjugate vaccine
Other Intervention Name(s)
13vPnC
Intervention Description
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
Time Frame
1 month after the infant series (6 Months of age)
Title
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
Time Frame
1 month after the infant series (7 Months of age)
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
Time Frame
1 month after the infant series (6 Months of age)
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
Time Frame
1 month after the infant series (7 Months of age)
Title
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
Time Frame
Approximately 16 months from the participation into the study to the end of study
Title
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
Time Frame
Approximately 16 months from the participation into study to the end of study
Title
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Time Frame
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Title
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Time Frame
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Title
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Time Frame
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Title
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Time Frame
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.
Time Frame
1 month after the infant series (6 Months of age)
Title
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.
Time Frame
1 month after the infant series (7 Months of age)
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
Time Frame
1 month after the infant series (6 Months of age)
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.
Time Frame
1 month after the infant series (7 Months of age)
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.
Time Frame
1 month after the toddler dose (13 Months of age)
Title
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.
Time Frame
1 month after the toddler dose (13 Months of age)
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.
Time Frame
1 month after the toddler dose (13 Months of age)
Title
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.
Time Frame
1 month after the infant series (6 Months of age)
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.
Time Frame
1 month after the infant series (6 Months of age)
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.
Time Frame
1 month after the toddler dose (13 Months of age)
Title
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.
Time Frame
1 month after the infant series (6 Months of age)
Title
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.
Time Frame
1 month after the toddler dose (13 Months of age)
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.
Time Frame
1 month after the infant series (6 Months of age)
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.
Time Frame
1 month after the toddler dose (13 Months of age)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
77 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
Previous vaccination with licensed or investigational pneumococcal vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal vaccines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu Province Guanyun County Center for Disease prevention and Control
City
Guanyun County,
State/Province
Jiangsu
ZIP/Postal Code
222200
Country
China
Facility Name
Jiangsu Province Hongze County Center for Disease prevention and Control
City
Huaian City
State/Province
Jiangsu
ZIP/Postal Code
223100
Country
China
Facility Name
Jiangsu Province Huaiyin District Center for Disease prevention and Control
City
Huaian City
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Jiangsu Province Lianshui County Center for Disease prevention and Control
City
Lianshui County
State/Province
Jiangsu
ZIP/Postal Code
223400
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
31626050
Citation
Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458.
Results Reference
derived
PubMed Identifier
27254028
Citation
Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851015&StudyName=A%20Study%20Evaluating%2013-Valent%20Pneumococcal%20Conjugate%20Vaccine%20%2813vPnC%29%20In%20Healthy%20Infants%20In%20China
Description
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Learn more about this trial
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
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