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A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01692886
First received: July 11, 2012
Last updated: July 15, 2014
Last verified: July 2014
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
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

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

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
Health Authority: China: Food and Drug Administration

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 September 28, 2016