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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)
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