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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Conjugate Vaccine; Pneumococcal Infections

Treatments: Biological: 13vPnC; Biological: Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03574389

B1851178

Details and patient eligibility

About

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

Enrollment: 936 patients

Sex: All

Ages: 42 days to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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936 participants in 2 patient groups

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Experimental group

Description:

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.

Treatment:

Biological: 13vPnC

Haemophilus influenzae type b (Hib)

Active Comparator group

Description:

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.

Treatment:

Biological: Hib