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A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

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ClinicalTrials.gov Identifier: NCT03574389
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Pneumococcal Conjugate Vaccine Biological: 13vPnC Biological: Hib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3 Open-label Trial To Assess The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Infants And Young Children In China Who Are Naive To Pneumococcal Vaccination
Actual Study Start Date : June 23, 2018
Estimated Primary Completion Date : August 16, 2019
Estimated Study Completion Date : August 24, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
  1. Participants in cohort 1 will receive each dose of 13vPnC in months 2, 4 and 6, and then a booster dose during months 12-15.
  2. Participants in cohort 2 will receive first dose dose 13vPnC at the age of months 7(included) to months 12 (less than months 12), and the second dose will be given at least 28 days after first dose, and the third dose will be months 12 to 15 (and at least 56 days after the second dose).
  3. Participants in cohort 3 will receive the first dose of 13vPnC during 1 (included) to 2 years (less than 2 years of age) of age, and the second dose will be given at least 56 days after first dose.
  4. Participants in cohort 4 will receive only one dose at the age of 2 (included) to 6 (less than 6 years of age) years of age.
Biological: 13vPnC
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Active Comparator: Haemophilus influenzae type b (Hib)
  1. No participants in cohort 1 will receive Hib vaccine.
  2. Participants in cohort 2 will receive the first dose of Hib vaccine at the age of months 7 (included) to 12 (less than 12 months), and the second dose will be given at least 28 days after the first dose, the third dose will following local practice or national recommendation at the discretion of the investigator.
  3. Participants in cohorts 3 and 4 will receive the only one dose Hib vaccine at the age of 1 (included) to 6 (less than 6 years) years of age.
Biological: Hib
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose




Primary Outcome Measures :
  1. Serotype-specific IgG geometric mean concentrations(GMCs) for each of the pneumococcal serotypes compared to IgG GMCs [ Time Frame: 1 month after the last dose of 13vPnC in cohorts 2, 3 and 4 and 1 month after the infant series in cohort 1 ]
    The serotype-specific IgG geometric mean concentrations (GMCs) for each of the pneumococcal serotypes measured 1 month after the last dose of 13vPnC in Cohort 2, 3, 4 compared to IgG GMCs measured 1 month after the infant series in Cohort 1.

  2. Number of local reactions and systemic events in Cohorts 2, 3 and 4 [ Time Frame: 7 days after each vaccination ]
    The incidence of local reactions and systemic events (including the use of antipyretic medication) in the 7 days after each vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.

  3. Number of newly diagnosed chronic medical conditions in Cohort 2, 3 and 4 [ Time Frame: 1 month after the last study vaccination to 6 months after the last study vaccination ]
    The incidence of newly diagnosed chronic medical conditions from 1 month after the last study vaccination (13vPnC or Hib) to 6 months after the last study vaccination in Cohort 2, 3 and 4.


Secondary Outcome Measures :
  1. Opsonophagocytic activity (OPA) to the vaccine specific serotypes compared to vaccine specific responses OPA [ Time Frame: 1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1. ]
    • The serotype-specific OPA geometric mean titers (GMTs) for each of the pneumococcal serotypes measured in a subset of approximately 50 subjects per cohort measured 1 month after the last dose of 13vPnC in Cohort 2, 3, 4 compared to OPA GMTs measured 1 month after the infant series in Cohort 1.

  2. Serotype specific IgG GMC and OPA GMTs for each of the pneumococcal serotypes compared to IgG and OPA [ Time Frame: 1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months. ]

    • Serotype specific IgG GMC in all subjects and OPA GMTs in approximately 50 subjects per cohort vaccinated with 13vPnC (Cohorts 1,2 ,3 4) and approximately 25 subjects per cohorts vaccinated with Hib (Cohort 2, 3, 4) using blood drawn at the following visits:

    • Cohort 2: Visit 1, Visit 4
    • Cohort 3: Visit 1, Visit 3
    • Cohort 4: Visit 1, Visit 2

  3. Serotype specific IgG GMC for each of the pneumococcal serotypes [ Time Frame: Before vaccination through 5 years of age ]
    • Serotype specific IgG GMC in all subjects and OPA GMTs in approximately 50 subjects at all times points in Cohort 1.



Information from the National Library of Medicine

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Ages Eligible for Study:   42 Days to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
  • Aged 6 weeks (42 days) to <6 years at the time of consent.
  • Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.
  • Other acute or chronic medical or psychiatric 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.
  • Vaccination with licensed or investigational pneumococcal vaccine.
  • Previous vaccination with licensed or investigational Hib vaccine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574389


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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China, Jiangsu
Huaiyin District Center for Disease Prevention and Control Recruiting
Huaian, Jiangsu, China, 223300
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03574389     History of Changes
Other Study ID Numbers: B1851178
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs