Meningitis, MeningococcalPhase 3NCT00161928
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
A Phase 3 study testing Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT) in people with Meningitis, Meningococcal, run by Pfizer at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
- Type of treatment
- Vaccines
- How many people
- 330 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Apr 2002to Jan 2003
- Phase
- Phase 3
- 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 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany12 sites
Neuschwansteinstrasse 5
Augsburg, 86163
Marktplatz 3
Bad Saulgau, 88348
Hasenheide 66
Berlin, 10967
Hauptstrasse 9
Bietigheim-Bissingen, 74321
Rheinstrasse13
Ettenheim, 77955
Solothurner Strasse 2
Heilbronn, 74072
Haupstrasse 240
Kehl, 77694
Löpsinger Strasse 8
Nördlingen, 86720
Tuchbergstrasse 2
Oberndorf / Neckar, 78727
Asternweg 11a
Offenburg, 77656
Falkensteiner Strasse 24
Roding, 93426
Broner Platz 6
Weingarten, 88250
Austria2 sites
Freistädter Strasse 290
Linz, 4040
Grieskirchner Strasse 17
Wels, 4600
About this study
Official title: 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
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.
- Conditions
- Meningitis, Meningococcal
- Being tested
- Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
- Keywords
- Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)Biological
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 startApr 2002
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, MeningococcalStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161928
- Sponsor's protocol ID
- 216
- 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
- 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
- ClinicalTrials.gov ID
- NCT00161928
- Acronym / sponsor ID
- 216
- Conditions
- Meningitis, Meningococcal
- Keywords
- Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Jan 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 NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT) | Biological | – |
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.
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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.
Baxter BioScience Investigator principal investigator
Baxter Healthcare Corporation
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT) in people with Meningitis, Meningococcal, run by Pfizer at 14 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 14 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.