Clinical trial NCT00676091: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Keywords: Pneumococcal conjugate vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 354
Sex: ALL
Minimum age (years): 28
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.


Eligibility criteria: Inclusion criteria:

* Healthy 1 month old infants
* Available for the duration of the study and reachable by telephone
* Able to complete two blood drawing procedures during the study

Exclusion criteria:

* Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
* Bleeding disorder, immune deficiency or significant chronic or congenital disease
* Previous receipt of blood products or immune globulin

Primary outcomes:
measure: Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
timeFrame: 1 Month after the infant series (7 Months of age)
measure: Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
measure: Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
Other outcomes:
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after dose 1 (2 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after dose 2 (4 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 (6 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after toddler dose (12 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after dose 1 (2 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after dose 2 (4 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 (6 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after toddler dose (12 months of age)
Locations:
city: Curitiba
country: Brazil
city: Florianopolis
country: Brazil
city: Sau Paulo
country: Brazil
city: Sau Paulo
country: Brazil
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: