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

Last updated on July 14, 2018

FOR MORE INFORMATION
Study Location
Huaiyin District Center for Disease Prevention and Control
Huaian, Jiangsu, 223300 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42+ days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Healthy infants and children as determined by medical history, physical examination,
and judgment of the investigator.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03574389
Pfizer
Recruiting
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

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A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children
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
The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pneumococcal Infections
  • Pneumococcal Conjugate Vaccine
  • Biological: 13vPnC
    suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
  • Biological: Hib
    suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
  • 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.
    Intervention: Biological: 13vPnC
  • 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.
    Intervention: Biological: Hib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
656
Same as current
August 23, 2023
August 15, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
42 Days to 5 Years   (Child)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
China
 
 
NCT03574389
B1851178
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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