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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01193582
Other study ID # B1841008
Secondary ID B1841008
Status Completed
Phase Phase 4
First received August 31, 2010
Last updated September 17, 2013
Start date September 2010
Est. completion date September 2012

Study information

Verified date September 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 505
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 121 Days to 72 Months
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age
Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age
Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age
Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age

Locations

Country Name City State
China Baolixiang Clinic Baoli Town,Yongfu County Guangxi
China Guangfuxiang Clinic Guangfu Town, Yongfu County Guangxi
China Luojin Clinic Luojin Town, Yongfu County Guangxi
China Yongfu County CDC Yongfu County Guangxi
China Yongfu County Clinic Yongfu County Guangxi

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar 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. 1 month after last dose in each group No
Primary Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group 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. Baseline No
Secondary Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1 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. 1 month after third dose of Prevenar in Group 1 No
Secondary 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. 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. Pre-vaccination to 1 month after third dose of Prevenar in Group 1 No
Secondary Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2 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. 1 month after second dose of Prevenar in Group 2 No
Secondary GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2. 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. Pre-vaccination to 1 month after second dose of Prevenar in Group 2 No
Secondary Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3 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. 1 month after first dose of Prevenar in Group 3 No
Secondary GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3. 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. Pre-vaccination to 1 month after first dose of Prevenar in Group 3 No
Secondary Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose. 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. 12 months after the last dose No
Secondary 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. 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. Pre-vaccination to 12 months after the last dose No
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