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Trial record 1 of 1 for:    NCT03548337
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Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

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ClinicalTrials.gov Identifier: NCT03548337
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE May 31, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group. [ Time Frame: Within the 7 days after the first dose of the infant series ]
    Within the 7 days after the first dose of the infant series
  • Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group [ Time Frame: Within the 7 days after the second dose of the infant series ]
    Within the 7 days after the second dose of the infant series
  • Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group [ Time Frame: Within the 7 days after the third dose of the infant series ]
    Within the 7 days after the third dose of the infant series
  • Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group [ Time Frame: Within the 7 days after the toddler dose ]
    Within the 7 days after the toddler dose
  • Incidence of AEs in the MDV group and in the PFS group from the first dose up to 1 month after the infant series [ Time Frame: First dose up to 1 month after the infant series ]
    First dose up to 1 month after the infant series
  • Incidence of AEs in the MDV group and in the PFS group from the toddler dose up to 1 month after the toddler dose [ Time Frame: From the toddler dose up to 1 month after the toddler dose. ]
    From the toddler dose up to 1 month after the toddler dose.
  • Incidence of serious adverse events (SAEs) in the MDV group and in the PFS group from the first dose up to 1 month after the toddler dose [ Time Frame: First dose up to 1 month after the toddler dose. ]
    First dose up to 1 month after the toddler dose.
  • Incidence of newly diagnosed chronic medical conditions in the MDV group and in the PFS group from 1 month after the infant series up to the toddler dose [ Time Frame: From 1 month after the infant series up to the toddler dose ]
    From 1 month after the infant series up to the toddler dose
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03548337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • The proportion of subjects with IgG concentrations equal to or above the defined threshold for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group
  • The proportion of subjects with IgG concentrations equal to or above the defined threshold for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group
  • The serotype-specific IgG GMC for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group
  • The serotype-specific IgG GMC for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group
  • The serotype-specific OPA GMT for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group
  • The serotype-specific OPA GMT for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group
  • The proportion of subjects achieving a serotype-specific OPA titer ≥ the lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group
  • The proportion of subjects achieving a serotype-specific OPA titer ≥ the lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Official Title  ICMJE A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13- VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS WHEN GIVEN WITH ROUTINE PEDIATRIC VACCINES IN HEALTHY INFANTS IN INDIA
Brief Summary A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Detailed Description A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines
Intervention  ICMJE Biological: 13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Study Arms  ICMJE
  • Active Comparator: 13vPnC with 2-PE from a MDV
    Multi Dose Vial with preservative
    Intervention: Biological: 13vPnC
  • Active Comparator: 13vPnC without 2-PE in a PFS
    Pre Filled Syringe without preservative
    Intervention: Biological: 13vPnC
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 25, 2019)
299
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
300
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
  2. Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0.)
  4. Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone.
  5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  6. Weight of 3.0 kg or greater at the time of vaccination.

Exclusion Criteria:

  1. Infant who is a direct descendant (child, grandchild) of

    • Investigator site staff members directly involved in the conduct of the study, or
    • Site staff members otherwise supervised by the investigator, or
    • Pfizer employees directly involved in the conduct of the study.
  2. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
  3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
  4. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
  7. Major known congenital malformation or serious chronic disorder.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb's palsy.
  9. Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 72 Days   (Child)
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 NCT03548337
Other Study ID Numbers  ICMJE B4671004
INDIA INFANT MDV ( Other Identifier: Alias Study Number )
2016-005134-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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 April 2019

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