Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
A Randomized, Open-Label Trial of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
1 other identifier
interventional
330
2 countries
14
Brief Summary
The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2002
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedMay 21, 2015
May 1, 2015
September 8, 2005
May 20, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Male and female volunteers infants, aged 2 to 6 months
- Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial)
- Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation
- Parent(s)/legal guardian and infant will be available for the duration of the study
You may not qualify if:
- History of any vaccine-related contraindicating event (e.g. anaphylaxis)
- Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction
- Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period
- Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product
- Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
- Subjects who have previously received a vaccination against Hep B or meningococcal C
- Subjects who have received banked human blood or immunoglobulins within one month of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (14)
Freistädter Strasse 290
Linz, 4040, Austria
Grieskirchner Strasse 17
Wels, 4600, Austria
Neuschwansteinstrasse 5
Augsburg, 86163, Germany
Marktplatz 3
Bad Saulgau, 88348, Germany
Hasenheide 66
Berlin, 10967, Germany
Hauptstrasse 9
Bietigheim-Bissingen, 74321, Germany
Rheinstrasse13
Ettenheim, 77955, Germany
Solothurner Strasse 2
Heilbronn, 74072, Germany
Haupstrasse 240
Kehl, 77694, Germany
Löpsinger Strasse 8
Nördlingen, 86720, Germany
Tuchbergstrasse 2
Oberndorf / Neckar, 78727, Germany
Asternweg 11a
Offenburg, 77656, Germany
Falkensteiner Strasse 24
Roding, 93426, Germany
Broner Platz 6
Weingarten, 88250, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baxter BioScience Investigator
Baxter Healthcare Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 13, 2005
Study Start
April 1, 2002
Study Completion
January 1, 2003
Last Updated
May 21, 2015
Record last verified: 2015-05