Clinical trial NCT00368966: 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 Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Keywords: Pneumococcal
Pediatric
Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 619
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 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 Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
timeFrame: One month after 2-doses of the infant series (5 months of age)
measure: Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
timeFrame: One month after 2-doses of the infant series (5 months of age)
measure: Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
timeFrame: One month after 2-doses of the infant series (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 Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After 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: Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
timeFrame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
measure: Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
timeFrame: One month after the 3-dose infant series (7 months of age) and the toddler dose (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 the Toddler Dose
timeFrame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
measure: Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
timeFrame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
measure: Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After 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:
Other outcomes:
Locations:
city: Ferrol
country: Spain
state: A Coruna
city: Santiago de Compostela
country: Spain
state: A Coruna
city: Argentona
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Sant Adria de Besos
country: Spain
state: Barcelona
city: Sant Cugat del Valles
country: Spain
state: Barcelona
city: Sant Cugat del Valles
country: Spain
state: Barcelona
city: Bilbao
country: Spain
state: Bizkaia
city: Burela
country: Spain
state: Lugo
city: Alcorcon
country: Spain
state: Madrid
city: Fuenlabrada
country: Spain
state: Madrid
city: Getafe
country: Spain
state: Madrid
city: Getafe
country: Spain
state: Madrid
city: Mostoles
country: Spain
state: Madrid
city: Parla
country: Spain
state: Madrid
city: Antequera
country: Spain
state: Malaga
city: Pamplona
country: Spain
state: Navarra
city: Vigo
country: Spain
state: Pontevedra
city: Burjassot
country: Spain
state: Valencia
city: La Eliana
country: Spain
state: Valencia
city: Quart de Poblet
country: Spain
state: Valencia
city: A Coruna
country: Spain
city: Almeria
country: Spain
city: Almeria
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Ourense
country: Spain
city: Sevilla
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
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.
citation: Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.