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Completed

NCT Number: NCT01193582

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

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

121 day–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baolixiang Clinic, Baoli Town,Yongfu County, Guangxi, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevenar

Biological

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

4 doses starting from 121 to < 212 days of age

Primary outcomes

  1. Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar

    Time frame: 1 month after last dose in each group

    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.

  2. Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group

    Time frame: Baseline

    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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Acronym: 6114A1-4000-CN

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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