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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-23

Study Completion Date

2023-10-13

Brief Summary

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

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Detailed Description

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Conditions

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Pneumococcal Infections Pneumococcal Conjugate Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

13vPnC

Intervention Type BIOLOGICAL

suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

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.

Group Type ACTIVE_COMPARATOR

Hib

Intervention Type BIOLOGICAL

suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Interventions

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13vPnC

suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Intervention Type BIOLOGICAL

Hib

suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

42 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes