Clinical Trials Logo
  1. Home
  2. Pneumococcal Infection
  3. NCT01692886
  4. Details
NCT01692886 Clinical Trial

A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

Pneumococcal Infection Clinical Trial

Official title:
A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01692886
Other study ID # B1851015
Secondary ID 6096A1-3019
Status Completed
Phase Phase 3
First received July 11, 2012
Last updated July 15, 2014
Start date August 2012
Est. completion date April 2014

Study information
Verified date July 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

Recruitment information / eligibility
Status Completed
Enrollment 1674
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 42 Days to 77 Days
Eligibility Inclusion Criteria:

1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment.

2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

3. Contraindication to vaccination with pneumococcal vaccines.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 7-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
• 13-valent Pnumococcal Conjugate vaccine
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
• 13-valent Pnumococcal Conjugate vaccine
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
• 13-valent Pnumococcal Conjugate vaccine
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

Locations
Country Name City State
China Jiangsu Province Guanyun County Center for Disease prevention and Control Guanyun County, Jiangsu
China Jiangsu Province Hongze County Center for Disease prevention and Control Huaian City Jiangsu
China Jiangsu Province Huaiyin District Center for Disease prevention and Control Huaian City Jiangsu
China Jiangsu Province Lianshui County Center for Disease prevention and Control Lianshui County Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2. 1 month after the infant series (6 Months of age)
Primary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35 mcg/mL 1 Month After the Infant Series in Group 3. 1 month after the infant series (7 Months of age)
Primary Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2. 1 month after the infant series (6 Months of age)
Primary Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3. 1 month after the infant series (7 Months of age)
Primary Percentage of Participants Reporting Adverse Events in Group 1 and Group 2. Approximately 16 months from the participation into the study to the end of study
Primary Percentage of Participants Reporting Adverse Events in Group 3 and Group 4. Approximately 16 months from the participation into study to the end of study
Primary Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2. Seven days after each pneumococcal vaccination dose within the period up to 12 months
Primary Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4. Seven days after each pneumococcal vaccination dose within the period up to 12 months
Primary Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2. Seven days after each pneumococcal vaccination dose within the period up to 12 months
Primary Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4. Seven days after each pneumococcal vaccination dose within the period up to 12 months
Secondary Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer = Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2. 1 month after the infant series (6 Months of age)
Secondary Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer = Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3. 1 month after the infant series (7 Months of age)
Secondary Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2. 1 month after the infant series (6 Months of age)
Secondary Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3. 1 month after the infant series (7 Months of age)
Secondary Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3. 1 month after the toddler dose (13 Months of age)
Secondary Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer = Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3. 1 month after the toddler dose (13 Months of age)
Secondary Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3. 1 month after the toddler dose (13 Months of age)
Secondary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35 mcg/mL 1 Month After the Infant Series in Group 4. 1 month after the infant series (6 Months of age)
Secondary Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4. 1 month after the infant series (6 Months of age)
Secondary Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4. 1 month after the toddler dose (13 Months of age)
Secondary Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer = Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4. 1 month after the infant series (6 Months of age)
Secondary Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer = Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4. 1 month after the toddler dose (13 Months of age)
Secondary Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4. 1 month after the infant series (6 Months of age)
Secondary Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4. 1 month after the toddler dose (13 Months of age)
See also
  Status Clinical Trial Phase
Completed NCT02463539 - Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis N/A
Completed NCT03095326 - Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia Phase 4
Completed NCT02260882 - Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902) Phase 4
Completed NCT02572635 - A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax Phase 1
Completed NCT01654263 - A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine Phase 2
Completed NCT01531322 - A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects Phase 1
Completed NCT00496093 - Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011) Phase 3
Completed NCT02062281 - Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults Phase 4
Completed NCT00133549 - 9-valent CRM 197 Pneumococcal Phase 2
Completed NCT03467984 - A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants Phase 2
Active, not recruiting NCT03489018 - The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants Phase 4
Recruiting NCT02463578 - Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis N/A
Completed NCT00535730 - ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED) Phase 3
Completed NCT02558751 - Pneumonia Vaccine in Aging HIV Positive Individuals Phase 0
Completed NCT02515240 - Immune Response to Pneumococcal Vaccination in HIV Infected Individuals Phase 0
Completed NCT00560950 - Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007) Phase 3
Completed NCT05425732 - Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) Phase 3
Completed NCT03619252 - Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents Phase 4
Not yet recruiting NCT03549208 - A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Phase 1
Not yet recruiting NCT03341195 - Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan N/A

External Links