Clinical trial NCT00366678: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in 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 Routine Pediatric Vaccinations in France.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Keywords: Safety
Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 613
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 pediatric vaccines in France.


Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

· Known contraindication to vaccines.

Primary outcomes:
measure: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
timeFrame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
measure: Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
timeFrame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
measure: Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
timeFrame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
measure: Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
timeFrame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
measure: Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
timeFrame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
measure: Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
timeFrame: One month after the 3-Dose Infant Series (at 5 months of age)
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
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
timeFrame: One month after the 3-Dose Infant Series (at 5 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
timeFrame: One month after the toddler dose (at 13 months of age)
measure: Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
timeFrame: One month after the Toddler Dose (at 13 months of age)
measure: Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
timeFrame: One month after the toddler dose (at 13 months of age)
measure: Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
timeFrame: One month after the toddler dose (at 13 months of age)
Other outcomes:
Locations:
city: Albi
country: France
city: Amiens
country: France
city: Ancenis
country: France
city: Blanquefort
country: France
city: Bondues
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Chalons en champagne
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Draguignan
country: France
city: Ecully
country: France
city: Essey-les-nancy
country: France
city: Floirac
country: France
city: Frejus
country: France
city: Garges-les-Gonesse
country: France
city: Illkirch
country: France
city: Joue les tours
country: France
city: Le havre
country: France
city: Le plessis-trevise
country: France
city: Le pontet
country: France
city: Les lilas
country: France
city: Les sables d'olonne
country: France
city: Libourne
country: France
city: Lingolsheim
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Marcq en baroeul
country: France
city: Maromme
country: France
city: Moutiers
country: France
city: Nancy
country: France
city: Nice
country: France
city: Nogent sur marne
country: France
city: Nogent-sur-marne
country: France
city: Oullins
country: France
city: Paris
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Thionville
country: France
city: Tours
country: France
city: Tresses melac
country: France
city: Vandoeuvre les nancy
country: France
city: Vaulx-en-velin
country: France
city: Villeneuve d'ascq
country: France
city: Vitry-sur-seine
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: