Meningitis, MeningococcalPhase 2NCT00314041
Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
A Phase 2 study testing Meningococcal C and DTP/Hib in people with Meningitis, Meningococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines. Read more about this study
- Who is it for?
- Ages 7 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Meningococcal C and DTP/Hib
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jun 1997to Apr 1998
- Phase
- Phase 2
- 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 7 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 7-10 weeks of age eligible to receive routine immunization
Who cannot join
None listed.
About this study
Official title: A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age.
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.
Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory
- Conditions
- Meningitis, Meningococcal
- Being tested
- Meningococcal C, DTP/Hib
- Keywords
- Infant, Conjugate vaccine, Meningococcal, Antibody, Immune memory, Health, Meningococcal Vaccines
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal CBiological
DTP/HibBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody responses to MnCC and concomitant vaccines
Secondary outcomes (1)
Safety and reactogenicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startJun 1997
- Primary completionApr 1998
- Study completionApr 1998
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For United Kingdom, ukmedinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314041
- Sponsor's protocol ID
- 6029A1 D110 P500
- Status last verified
- Feb 2013
- First submitted
- 10 Apr 2006
- Last updated
- 21 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age.
- ClinicalTrials.gov ID
- NCT00314041
- Acronym / sponsor ID
- 6029A1 D110 P500
- Conditions
- Meningitis, Meningococcal
- Keywords
- Infant, Conjugate vaccine, Meningococcal, Antibody, Immune memory, Health, Meningococcal Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 1997
- Primary completion
- Apr 1998 (actual)
- Study completion
- Apr 1998 (actual)
- First posted
- 12 Apr 2006 (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.
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.
Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 7 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants 7-10 weeks of age eligible to receive routine immunization
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Meningococcal C | Biological | – |
| DTP/Hib | Biological | – |
Primary outcome
Antibody responses to MnCC and concomitant vaccines
1 secondary outcome
Safety and reactogenicity
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 Feb 2013.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For United Kingdom, ukmedinfo@wyeth.com
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meningococcal C and DTP/Hib in people with Meningitis, Meningococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 1 inclusion and 0 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Antibody responses to MnCC and concomitant vaccines. It is what the study was designed to measure, not a finding.
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 Feb 2013.