A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria (6114A1-4000-CN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01193582
First received: August 31, 2010
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.


Condition Intervention Phase
Pneumococcal Infections
Biological: Prevenar
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar [ Time Frame: 1 month after last dose in each group ] [ Designated as safety issue: No ]
    Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

  • Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.


Secondary Outcome Measures:
  • Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1 [ Time Frame: 1 month after third dose of Prevenar in Group 1 ] [ Designated as safety issue: No ]
    Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

  • Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1. [ Time Frame: Pre-vaccination to 1 month after third dose of Prevenar in Group 1 ] [ Designated as safety issue: No ]
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

  • Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2 [ Time Frame: 1 month after second dose of Prevenar in Group 2 ] [ Designated as safety issue: No ]
    Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

  • GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2. [ Time Frame: Pre-vaccination to 1 month after second dose of Prevenar in Group 2 ] [ Designated as safety issue: No ]
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

  • Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3 [ Time Frame: 1 month after first dose of Prevenar in Group 3 ] [ Designated as safety issue: No ]
    Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

  • GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3. [ Time Frame: Pre-vaccination to 1 month after first dose of Prevenar in Group 3 ] [ Designated as safety issue: No ]
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

  • Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose. [ Time Frame: 12 months after the last dose ] [ Designated as safety issue: No ]
    Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

  • GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose. [ Time Frame: Pre-vaccination to 12 months after the last dose ] [ Designated as safety issue: No ]
    GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.


Enrollment: 505
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

4 doses starting from 121 to < 212 days of age

Experimental: Group 2 Biological: Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

3 doses starting from 212 days to < 12 months of age

Experimental: Group 3 Biological: Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

2 doses starting from 12 months to < 24 months of age

Experimental: Group 4 Biological: Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

1 dose starting from 24 months to < 72 months of age


  Eligibility

Ages Eligible for Study:   121 Days to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Chinese male or female subjects.
  • Between 121 days to less than 72 months of age at the time of entry into the study.

Exclusion Criteria:

  • Receipt of previous vaccine against Pneumo
  • Previous anaphylactic reaction to any vaccine or part of a vaccine
  • Previous proven invasive Pneumo infection
  • Receipt of investigational drug or device within the proceeding 28 days
  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: NCT01193582

Locations
China, Guangxi
Baolixiang Clinic
Baoli Town,Yongfu County, Guangxi, China, 541902
Guangfuxiang Clinic
Guangfu Town, Yongfu County, Guangxi, China, 541803
Luojin Clinic
Luojin Town, Yongfu County, Guangxi, China, 541801
Yongfu County CDC
Yongfu County, Guangxi, China, 541800
Yongfu County Clinic
Yongfu County, Guangxi, China, 541800
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01193582     History of Changes
Other Study ID Numbers: B1841008, B1841008
Study First Received: August 31, 2010
Results First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Pfizer:
Prevenar
catch-up
pneumococcal
pneumonia

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 27, 2014