Clinical trial NCT01692886: A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infection
Keywords: 13vPnC
7vPnC
Healthy subjects
China
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 1674
Sex: ALL
Minimum age (years): 42
Maximum age (years): 77
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 month after the infant series (6 Months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
timeFrame: 1 month after the infant series (7 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
timeFrame: 1 month after the infant series (6 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
timeFrame: 1 month after the infant series (7 Months of age)
measure: Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
timeFrame: Approximately 16 months from the participation into the study to the end of study
measure: Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
timeFrame: Approximately 16 months from the participation into study to the end of study
measure: Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
timeFrame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
timeFrame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: 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.
timeFrame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: 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.
timeFrame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Secondary outcomes:
measure: 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.
timeFrame: 1 month after the infant series (6 Months of age)
measure: 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.
timeFrame: 1 month after the infant series (7 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
timeFrame: 1 month after the infant series (6 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.
timeFrame: 1 month after the infant series (7 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.
timeFrame: 1 month after the toddler dose (13 Months of age)
measure: 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.
timeFrame: 1 month after the toddler dose (13 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.
timeFrame: 1 month after the toddler dose (13 Months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.
timeFrame: 1 month after the infant series (6 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.
timeFrame: 1 month after the infant series (6 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.
timeFrame: 1 month after the toddler dose (13 Months of age)
measure: 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.
timeFrame: 1 month after the infant series (6 Months of age)
measure: 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.
timeFrame: 1 month after the toddler dose (13 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.
timeFrame: 1 month after the infant series (6 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.
timeFrame: 1 month after the toddler dose (13 Months of age)
Other outcomes:
Locations:
city: Guanyun County,
country: China
facility: Jiangsu Province Guanyun County Center for Disease prevention and Control
state: Jiangsu
city: Huaian City
country: China
facility: Jiangsu Province Hongze County Center for Disease prevention and Control
state: Jiangsu
city: Huaian City
country: China
facility: Jiangsu Province Huaiyin District Center for Disease prevention and Control
state: Jiangsu
city: Lianshui County
country: China
facility: Jiangsu Province Lianshui County Center for Disease prevention and Control
state: Jiangsu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458.
citation: Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248.