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

NCT03574389 | Completed Phase 3 Results

• 1 other identifier: B1851178
• Study Type: interventional
• Target: 936
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumococcal Infections; Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (7)

• 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

  Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

  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

  Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.

  Within 7 Days After Each Vaccination

• Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3

  Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.

  Within 7 Days After Each Vaccination

• Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4

  Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.

  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

  An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

  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

  Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.

• Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4

  An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.

  From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.

Secondary Outcomes (11)

• 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.

  Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.

• 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.

  Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose

• 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.

  Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last Dose

• 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).

  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.

• 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).

  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.

Study Arms (2)

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

EXPERIMENTAL

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.

Biological: 13vPnC

Haemophilus influenzae type b (Hib)

ACTIVE COMPARATOR

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.

Biological: Hib

Interventions

13vPnC BIOLOGICAL

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

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Hib BIOLOGICAL

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

Haemophilus influenzae type b (Hib)

Eligibility Criteria

• Age: 42 Days - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Huaiyin District Center for Disease Prevention and Control

Huaian, Jiangsu, 223300, China

Location

Guanyun County Disease Control and Prevention

Lianyungang, Jiangsu, China

Location

Related Publications (1)

• Chu K, Hu Y, Pan H, Wu J, Zhu D, Young MM Jr, Luo L, Yi Z, Giardina PC, Gruber WC, Scott DA, Watson W. A randomized, open-label, phase 3 study evaluating safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in Chinese infants and children under 6 years of age. Hum Vaccin Immunother. 2023 Aug 1;19(2):2235926. doi: 10.1080/21645515.2023.2235926.

  PMID: 37549923 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 2, 2018
• Study Start: June 23, 2018
• Primary Completion: August 23, 2021
• Study Completion: October 13, 2023
• Last Updated: November 5, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)