A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

Pneumococcal Infections Clinical Trial

— 6114A1-4000-CN  

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.

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

• Pneumococcal Infections

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

External Links

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