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A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01692886
First received: July 11, 2012
Last updated: July 15, 2014
Last verified: July 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Pneumococcal Infection | Biological: 7-valent Pneumococcal Conjugate Vaccine Biological: 13-valent Pnumococcal Conjugate vaccine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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. [ Time Frame: 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) ]
- 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) ]
- 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) ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 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. [ Time Frame: 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
| Enrollment: | 1674 |
| Study Start Date: | August 2012 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 7vPnC (3-, 4-, 5-, 12-Month) |
Biological: 7-valent Pneumococcal Conjugate Vaccine
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 Name: 7vPnC
|
| Experimental: 13vPnC (3-, 4-, 5-, 12-Month) |
Biological: 13-valent Pnumococcal Conjugate vaccine
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 Name: 13vPnC
|
| Experimental: 13vPnC (2-, 4-, 6-, 12-Month) |
Biological: 13-valent Pnumococcal Conjugate vaccine
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 Name: 13vPnC
|
| Experimental: 13vPnC (3-, 5-, 12-Month) |
Biological: 13-valent Pnumococcal Conjugate vaccine
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 Name: 13vPnC
|
Eligibility| Ages Eligible for Study: | 42 Days to 77 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692886
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692886
Locations
| China, Jiangsu | |
| Jiangsu Province Guanyun County Center for Disease prevention and Control | |
| Guanyun County,, Jiangsu, China, 222200 | |
| Jiangsu Province Hongze County Center for Disease prevention and Control | |
| Huaian City, Jiangsu, China, 223100 | |
| Jiangsu Province Huaiyin District Center for Disease prevention and Control | |
| Huaian City, Jiangsu, China, 223300 | |
| Jiangsu Province Lianshui County Center for Disease prevention and Control | |
| Lianshui County, Jiangsu, China, 223400 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01692886 History of Changes |
| Other Study ID Numbers: |
B1851015 6096A1-3019 |
| Study First Received: | July 11, 2012 |
| Last Updated: | July 15, 2014 |
Keywords provided by Pfizer:
|
13vPnC 7vPnC Healthy subjects China |
Additional relevant MeSH terms:
|
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017