Meningococcal Meninigitis, Serogroup CNCT00161941
Follow-up Study on the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens 1 Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in NeisVac-C Study 216
An observational study of Meningococcal Meninigitis, Serogroup C, run by Pfizer at 11 sites in 2 countries.
Trial summary
The primary aim of the study is to show that the antibody response to hepatitis B, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac® is not influenced by the concomitant administration of NeisVac-C. Read more about this study
- Who is it for?
- Ages 5 to 22 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meninigitis, Serogroup C
- How many people
- 321 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jun 2003to Dec 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 22 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Study subjects who completed study 216 will be eligible for participation in this study if:
- they received all 3 vaccinations with Hexavac during study 216 and the 4th Hexavac vaccination outside the study
- the subject's parent(s)/legal guardian(s) understands the study and has provided written informed consent for his/her child's study participation;
- a blood draw was performed after the 3rd vaccination during study 216.
Who cannot join
- Study subjects will be excluded from participation in this study if:
- they have received any vaccination containing hepatitis B, poliovirus or acellular pertussis toxin antigens other than Hexavac
- they have received a blood transfusion or immunoglobulins during the period from 28 days prior to the 4th Hexavac vaccination until study entry
- they have received another vaccine during the period from 28 days prior to the 4th Hexavac vaccination until study entry
- they are concurrently participating in or have participated in a clinical trial with an investigational medicinal product since the completion of study 216
- they suffer from a disease (e.g. autoimmune disease) or were undergoing a form of treatment that may be expected to influence immunological functions since the completion of study 216
- they have received systemic corticosteroids during the period from 28 days prior to the 4th Hexavac vaccination until study entry.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Neuschwansteinstrasse 5
Augsburg, 86163
Marktplatz 3
Bad Saulgau, 88348
Hauptrasse 9
Bietigheim-Bissingen, 74321
Rheinstrasse13
Ettenheim, 77955
Solothurner Strasse 2
Heilbronn, 74072
Hauptrasse 240
Kehl, 77694
Löpsinger Strasse 8
Nördlingen, 86720
Tuchbergstrass 2
Oberndorf / Neckar, 78727
Falkensteiner Str. 24
Roding, 93426
Berneckstrasse 19
Schrammberg, 78713
About this study
Official title: Open-label Multicenter Phase 3B Follow-up Study to Investigate the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens One Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in the NeisVac-C Non-interference Study 216
The primary aim of the study is to show that the antibody response to hepatitis B, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac® is not influenced by the concomitant administration of NeisVac-C.
- Conditions
- Meningococcal Meninigitis, Serogroup C
- Keywords
- Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis
- Medical subject headings
- Meningitis, Meningococcal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJun 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal Meninigitis, Serogroup CStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 321 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ulrich Behre, MD, Principal investigator, Private practice, Hauptstrasse, Kehl, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161941
- Sponsor's protocol ID
- 224
- Status last verified
- May 2015
- First submitted
- 8 Sep 2005
- Last updated
- 21 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Multicenter Phase 3B Follow-up Study to Investigate the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens One Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in the NeisVac-C Non-interference Study 216
- ClinicalTrials.gov ID
- NCT00161941
- Acronym / sponsor ID
- 224
- Conditions
- Meningococcal Meninigitis, Serogroup C
- Keywords
- Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Dec 2003
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to show that the antibody response to hepatitis B, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac® is not influenced by the concomitant administration of NeisVac-C.
Study design
Who may qualify
- Ages
- 5 to 22 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Study subjects who completed study 216 will be eligible for participation in this study if:
- they received all 3 vaccinations with Hexavac during study 216 and the 4th Hexavac vaccination outside the study
- the subject's parent(s)/legal guardian(s) understands the study and has provided written informed consent for his/her child's study participation;
- a blood draw was performed after the 3rd vaccination during study 216.
Key exclusion criteria (7 listed)
- they have received any vaccination containing hepatitis B, poliovirus or acellular pertussis toxin antigens other than Hexavac
- they have received a blood transfusion or immunoglobulins during the period from 28 days prior to the 4th Hexavac vaccination until study entry
- they have received another vaccine during the period from 28 days prior to the 4th Hexavac vaccination until study entry
- they are concurrently participating in or have participated in a clinical trial with an investigational medicinal product since the completion of study 216
- they suffer from a disease (e.g. autoimmune disease) or were undergoing a form of treatment that may be expected to influence immunological functions since the completion of study 216
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Behre, MD principal investigator
Private practice, Hauptstrasse, Kehl, Germany
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Meninigitis, Serogroup C, run by Pfizer at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.