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Trial record 1 of 1 for:    NCT02034877
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13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

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ClinicalTrials.gov Identifier: NCT02034877
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 14, 2014
Results First Submitted Date  ICMJE May 23, 2016
Results First Posted Date  ICMJE July 1, 2016
Last Update Posted Date July 1, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination [ Time Frame: Within 1 month after 13vPnC vaccination ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.
  • Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination ]
    Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
  • Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination [ Time Frame: 1 month after 13vPnC vaccination ]
    Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
  • Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination, 1 month after 13vPnC vaccination ]
    GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
  • Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination ]
    Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
  • Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination [ Time Frame: 1 month after 13vPnC vaccination ]
    Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • The proportion of subjects reporting adverse events (AEs) and serious adverse events (SAEs) within approximately 1 month after 13vPnC administration. [ Time Frame: Baseline to 1 month post vaccination ]
    Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) within approximately 1 month after 13vPnC administration.
  • Functional antibody titers as measured by serotype-specific opsonophagocytic activity (OPA) assays before and approximately 1 month after 13vPnC administration. [ Time Frame: Baseline to 1 month post vaccination ]
    To describe the immune responses to the 13 pneumococcal serotypes induced by 13vPnC
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
Official Title  ICMJE A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India
Brief Summary This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
Intervention  ICMJE
  • Biological: 13-valent Pneumococcal conjugate vaccine
    1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
  • Procedure: Blood sample collection
    10 mL of blood will be collected just before and approximately 1 month after vaccination.
Study Arms  ICMJE Experimental: 1
Interventions:
  • Biological: 13-valent Pneumococcal conjugate vaccine
  • Procedure: Blood sample collection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

Exclusion Criteria:

Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034877
Other Study ID Numbers  ICMJE B1851140
2014-001174-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP