Clinical trial NCT00474539: Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Keywords: Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 449
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.


Eligibility criteria: Inclusion Criteria:

* Healthy 2-month-old infants
* Available for the entire study period

Exclusion criteria:

* Previous vaccination with any vaccine before the start of the study
* Known contraindication to vaccination

Primary outcomes:
measure: Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
timeFrame: One month after infant series dose (at 5 months of age)
measure: Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
timeFrame: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
measure: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
timeFrame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
measure: Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
timeFrame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
measure: Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
timeFrame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
measure: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
timeFrame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: One month after toddler dose (at 16 months of age)
Other outcomes:
measure: Percentage of Participants Reporting Pre-Specified Local Reactions
timeFrame: During the 4-day period after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events
timeFrame: During the 4-day period after each dose
Locations:
city: Almeria
country: Spain
city: Almeria
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Coruna
country: Spain
city: Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Malaga
country: Spain
city: Ourense
country: Spain
city: Pamplona
country: Spain
city: Santiago de Compostela
country: Spain
city: Seville
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Vigo
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Spain: infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.