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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infection Biological: 7-valent Pneumococcal Conjugate Vaccine Biological: 13-valent Pnumococcal Conjugate vaccine Phase 3

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  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. [ Time Frame: 1 month after the infant series (6 Months of age) ]
  4. 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) ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 :
  1. 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) ]
  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. [ Time Frame: 1 month after the infant series (7 Months of age) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]

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

Inclusion Criteria:

  1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
  2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with pneumococcal vaccines.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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