Status:
COMPLETED
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Lead Sponsor:
Pfizer
Conditions:
13-valent Pneumococcal Vaccine
Premature Birth
Eligibility:
All Genders
42-98 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants wit...
Eligibility Criteria
Inclusion
- Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
Exclusion
- Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
- Previous anaphylactic reaction or allergy to any vaccine
- Contraindication to vaccination
- Known or suspected immune deficiency or immune suppression
- Major known congenital malformation or serious chronic disorder
- Significant neurological disorder
- Participation to another study
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01193335
Start Date
October 1 2010
End Date
January 1 2014
Last Update
May 11 2017
Active Locations (12)
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1
NZOZ "HIPOKRATES-II" Sp. z o.o.
Krakow, Poland, 31-223
2
Hanna Czajka Indywidualna Praktyka Specjalistyczna Lekarska
Krakow, Poland, 31-302
3
SP ZOZ Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego w Lodzi
Lodz, Poland, 91-347
4
Specjalistyczny ZOZ nad Matka i Dzieckiem
Poznan, Poland, 61-825