- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692886
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
July 15, 2014 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1674
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Guanyun County,, Jiangsu, China, 222200
- Jiangsu Province Guanyun County Center for Disease prevention and Control
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Huaian City, Jiangsu, China, 223100
- Jiangsu Province Hongze County Center for Disease prevention and Control
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Huaian City, Jiangsu, China, 223300
- Jiangsu Province Huaiyin District Center for Disease prevention and Control
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Lianshui County, Jiangsu, China, 223400
- Jiangsu Province Lianshui County Center for Disease prevention and Control
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 7vPnC (3-, 4-, 5-, 12-Month)
|
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
Other Names:
|
Experimental: 13vPnC (3-, 4-, 5-, 12-Month)
|
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
Other Names:
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
Other Names:
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Other Names:
|
Experimental: 13vPnC (2-, 4-, 6-, 12-Month)
|
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
Other Names:
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
Other Names:
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Other Names:
|
Experimental: 13vPnC (3-, 5-, 12-Month)
|
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
Other Names:
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
Other Names:
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the infant series (7 Months of age)
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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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the infant series (7 Months of age)
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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
|
Approximately 16 months from the participation into the study to the end of study
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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
|
Approximately 16 months from the participation into study to the end of study
|
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
|
Seven days after each pneumococcal vaccination dose within the period up to 12 months
|
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
|
Seven days after each pneumococcal vaccination dose within the period up to 12 months
|
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
|
Seven days after each pneumococcal vaccination dose within the period up to 12 months
|
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
|
Seven days after each pneumococcal vaccination dose within the period up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the infant series (7 Months of age)
|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the infant series (7 Months of age)
|
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)
|
1 month after the toddler dose (13 Months of age)
|
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)
|
1 month after the toddler dose (13 Months of age)
|
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)
|
1 month after the toddler dose (13 Months of age)
|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the toddler dose (13 Months of age)
|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the toddler dose (13 Months of age)
|
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)
|
1 month after the infant series (6 Months of age)
|
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)
|
1 month after the toddler dose (13 Months of age)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
July 11, 2012
First Submitted That Met QC Criteria
September 21, 2012
First Posted (Estimate)
September 25, 2012
Study Record Updates
Last Update Posted (Estimate)
July 16, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1851015
- 6096A1-3019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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