Status:
COMPLETED
NeisVac-C Single Prime Study in Infants
Lead Sponsor:
Pfizer
Conditions:
Neisseria Meningitidis
Eligibility:
All Genders
8-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
Eligibility Criteria
Inclusion
- Subject is an infant aged 8 to 11 weeks at the time of first vaccination
- Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination
- Subject was born at full term of pregnancy (\>= 37 weeks) with a birth weight \>= 2 kg
- The parent(s) or legally authorized representative of the subject provides written consent for participation
- The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol
- The parent(s) or legally authorized representative and the subject will be available for the duration of the study
- The parent(s) or legally authorized representative of the subject agrees to keep a subject diary
Exclusion
- Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines
- Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study
- Subject has a rash or dermatologic condition which may interfere with injection site reaction rating
- Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder
- Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response
- Subject has received any blood products or immunoglobulins within 60 days of study entry
- Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination
- Subject has previously been vaccinated against meningococcal C disease
- Subject has a known or suspected immune dysfunction
- Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.)
- Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
- Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study investigator or with a study team member; dependent relationships include close relatives (i.e. children, partner/spouse, siblings) as well as employees of the investigator or site conducting the study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
956 Patients enrolled
Trial Details
Trial ID
NCT01218451
Start Date
September 1 2010
End Date
June 1 2012
Last Update
May 21 2015
Active Locations (24)
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1
NZOZ Vitamed
Bydgoszcz, Poland, 85-021
2
Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka
Krakow, Poland, 31-503
3
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci
Lodz, Poland, 91-347
4
SP ZOZ Oddział Pediatyczny
Lubartów, Poland, 21-100