ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | NeisVac-C Single Prime Study in Infants | |||
Official Title ICMJE | A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Neisseria Meningitidis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 956 | |||
Original Estimated Enrollment ICMJE | 948 | |||
Actual Study Completion Date ICMJE | June 2012 | |||
Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 8 Weeks to 11 Weeks (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Poland, Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01218451 | |||
Other Study ID Numbers ICMJE | 670901 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |