A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
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ClinicalTrials.gov Identifier: NCT01692886 |
Recruitment Status
:
Completed
First Posted
: September 25, 2012
Last Update Posted
: July 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumococcal Infection | Biological: 7-valent Pneumococcal Conjugate Vaccine Biological: 13-valent Pnumococcal Conjugate vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1674 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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) ]

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Ages Eligible for Study: | 42 Days to 77 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692886
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01692886 History of Changes |
Other Study ID Numbers: |
B1851015 6096A1-3019 |
First Posted: | September 25, 2012 Key Record Dates |
Last Update Posted: | July 16, 2014 |
Last Verified: | July 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 |