Clinical trial NCT03574389: A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 936
Sex: ALL
Minimum age (years): 42
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
timeFrame: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
measure: Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
timeFrame: Within 7 Days After Each Vaccination
measure: Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
timeFrame: Within 7 Days After Each Vaccination
measure: Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
timeFrame: Within 7 Days After Each Vaccination
measure: Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4
timeFrame: From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.
measure: Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
timeFrame: From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.
measure: Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
timeFrame: From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.
Secondary outcomes:
measure: The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
timeFrame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
measure: The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
timeFrame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
measure: The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
timeFrame: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose
measure: Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
timeFrame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
timeFrame: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.
measure: Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1
timeFrame: From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.
measure: Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1
timeFrame: From 1 month after Vaccination 3 to Vaccination 4.
measure: Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1
timeFrame: From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.
measure: Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1
timeFrame: From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.
measure: Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1
timeFrame: From the Signing of the ICD to 6 Months After the Vaccination 4.
measure: Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
timeFrame: Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1
Other outcomes:
Locations:
city: Huaian
country: China
facility: Huaiyin District Center for Disease Prevention and Control
state: Jiangsu
city: Lianyungang
country: China
facility: Guanyun County Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: