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13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

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ClinicalTrials.gov Identifier: NCT01964716
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2013
First Posted Date  ICMJE October 17, 2013
Results First Submitted Date  ICMJE February 27, 2015
Results First Posted Date  ICMJE March 13, 2015
Last Update Posted Date March 13, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group [ Time Frame: 1 month after the infant series ]
    Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
  • Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group [ Time Frame: 1 month after the infant series ]
    Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
  • Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group [ Time Frame: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series ]
    Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
  • Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group [ Time Frame: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series ]
    Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
  • Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group [ Time Frame: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series ]
    Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
  • Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group [ Time Frame: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series ]
    Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
  • Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group [ Time Frame: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series ]
    Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
  • Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group [ Time Frame: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series ]
    Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series [ Time Frame: Dose 1 up to 28 to 42 days after dose 3 ]
    An AE was any untoward medical occurrence in a participants 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 are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 [ Time Frame: Informed consent up to Dose 1 ]
    An AE was any untoward medical occurrence in a participants 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. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • The percentage of subjects achieving a serotype-specific IgG antibody concentration ≥0.35 µg/mL for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group. [ Time Frame: Approximately 20 weeks of age ]
  • The serotype-specific IgG geometric mean concentration (GMC) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group (MDV group or SDS group). [ Time Frame: Approximately 20 weeks of age ]
  • The number of subjects reporting local reactions and systemic events in the 5 days after each vaccination in the multidose-vial group and in the single-dose-syringe group. [ Time Frame: Approximately 8 weeks, 12 weeks and 16 weeks of age ]
  • The number of subjects reporting AEs in the multidose-vial group and in the single-dose-syringe group. [ Time Frame: Approximately 8 weeks, 12 weeks , 16 weeks and 20 weeks of age ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series [ Time Frame: 1 month after the infant series ]
    Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
  • Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series [ Time Frame: 1 month after the infant series ]
    Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • The proportion of subjects in a subset achieving a serotype-specific OPA titer ≥ lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group. [ Time Frame: Approximately 20 weeks of age ]
  • The serotype-specific OPA geometric mean titer (GMT) for each of the pneumococcal serotypes 1 month after the infant series for each vaccine group. [ Time Frame: Approximately 20 weeks of age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
Official Title  ICMJE A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
Brief Summary

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccines
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
  • Biological: 13-valent pneumococcal conjugate vaccine
    Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Study Arms  ICMJE
  • Experimental: Multidose Vial Group
    Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: Single-Dose Syringe Group
    Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Publications * Idoko OT, Mboizi RB, Okoye M, Laudat F, Ceesay B, Liang JZ, Le Dren-Narayanin N, Jansen KU, Gurtman A, Center KJ, Scott DA, Kampmann B, Roca A. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial. Vaccine. 2017 May 31;35(24):3256-3263. doi: 10.1016/j.vaccine.2017.04.049. Epub 2017 May 4.

*   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: October 14, 2013)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 42 to 70 days at enrollment.
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study
  • Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal conjugate vaccine.
  • Receipt of blood products or gamma-globulin since birth
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 70 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964716
Other Study ID Numbers  ICMJE B4671001
2012-000482-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 February 2015

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