CompletedPhase 3

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

China936 participantsStarted 2018-06-23

Plain-language 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.

Who can participate

Age range42 Days – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

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

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

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

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.

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.

Trial details

NCT IDNCT03574389

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-23

Results submitted2022-08-23

View on ClinicalTrials.gov More Pneumococcal Infections trials

Who can participate

Age range42 Days – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

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

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

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

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.

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.