Study To Evaluate a 13-Valent Pneumococcal Conjugate Vaccine in Infants.
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaccines, Pneumococcal
Intervention: 13-valent Pneumococcal Conjugate Vaccine (Biological); 7 valent pneumococcal conjugate vaccine (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com
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.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Primary outcome: To compare immunogenicity of 13vPnC to Prevenar using serotype specific serum IgG antibody levels; to evaluate immunogenicity of antigens in concomitant vaccines; to assess safety by local injection site reactions and systemic events, and adverse events.
Eligibility
Minimum age: 42 Days.
Maximum age: 98 Days.
Gender(s): Both.
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
Locations and Contacts
A Coruna 15006, Spain
Almeria 04007, Spain
Almeria 04009, Spain
Almeria 04120, Spain
Barcelona 08017, Spain
Barcelona 08025, Spain
La Coruna 15270, Spain
Madrid 28041, Spain
Madrid 28021, Spain
Madrid 28041, Spain
Malaga 29015, Spain
Ourense 32005, Spain
Sevilla 41013, Spain
Valencia 46024, Spain
Valencia 46013, Spain
Valencia 46200, Spain
Valencia 46021, Spain
Valencia 46011, Spain
Valencia 46023, Spain
Valencia 46022, Spain
Valencia 46008, Spain
Santiago de Compostela, A Coruna 15706, Spain
Ferrol, A Coruna 15405, Spain
Sabadell, Barcelona 08208, Spain
Argentona, Barcelona 08310, Spain
Sant Cugat del Valles, Barcelona 08195, Spain
Sant Cugat del Valles, Barcelona 08197, Spain
Sant Adria de Besos, Barcelona 08930, Spain
Bilbao, Bizkaia 48013, Spain
Burela, Lugo 27880, Spain
Alcorcon, Madrid 28922, Spain
Getafe, Madrid 28900, Spain
Fuenlabrada, Madrid 28943, Spain
Mostoles, Madrid 28937, Spain
Getafe, Madrid 28902, Spain
Parla, Madrid 28980, Spain
Antequera, Malaga 29200, Spain
Pamplona, Navarra 31008, Spain
Vigo, Pontevedra 36204, Spain
La Eliana, Valencia 46183, Spain
Burjassot, Valencia 46110, Spain
Quart de Poblet, Valencia 46930, Spain
Additional Information
Starting date: October 2006
Ending date: July 2008
Last updated: December 21, 2007
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