HealthyPhase 4NCT00581035
Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time
A Phase 4 study testing Prevenar and Meningitec, Prevenar and Meningitec in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants Read more about this study
- Who is it for?
- Ages 42 to 63 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prevenar and Meningitec, Prevenar and Meningitec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2007
- Phase
- Phase 4
- 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 42 to 63 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 6 to 9 weeks
Who cannot join
None listed.
About this study
Official title: A Randomised Open Label Phase 4 Study to Evaluate the Safety and Immunogenicity of Concomitant Prevenar and Meningitec Compared to Prevenar Alone and Meningitec Alone When Used as Part of the Routine Vaccination Series in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants
- Conditions
- Healthy
- Being tested
- Prevenar and Meningitec, Prevenar, Meningitec
- Keywords
- Meningococcal disease, pneumococcal disease, meningitis
- Medical subject headings
- Meningococcal Infections, Pneumococcal Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar and MeningitecBiological
1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months
PrevenarBiological
1 dose at 2,3.5,6 and 12 months
MeningitecBiological
1 dose at 2,6 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Prevenar and Meningitec Receives: Biological: Prevenar and Meningitec |
| 2 | Experimental | Prevenar Receives: Biological: Prevenar |
| 3 | Experimental | Meningitec Receives: Biological: Meningitec |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pneumococcal and meningococcal responses achieved after the infant series
Measured: 7 months
Secondary outcomes (1)
The pneumococcal and meningococcal responses achieved after the toddler dose
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startJan 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 712 participants (actual)
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 Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581035
- Sponsor's protocol ID
- 6114A1-500
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open Label Phase 4 Study to Evaluate the Safety and Immunogenicity of Concomitant Prevenar and Meningitec Compared to Prevenar Alone and Meningitec Alone When Used as Part of the Routine Vaccination Series in Healthy Infants
- ClinicalTrials.gov ID
- NCT00581035
- Acronym / sponsor ID
- 6114A1-500
- Conditions
- Healthy
- Keywords
- Meningococcal disease, pneumococcal disease, meningitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- May 2007 (actual)
- First posted
- 27 Dec 2007 (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 purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Prevenar and MeningitecPrevenar and Meningitec |
| 2 | Experimental | Biological: PrevenarPrevenar |
| 3 | Experimental | Biological: MeningitecMeningitec |
Who may qualify
- Ages
- 42 to 63 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants aged 6 to 9 weeks
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 |
|---|---|---|
| Prevenar and Meningitec1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months | Biological | 1 |
| Prevenar1 dose at 2,3.5,6 and 12 months | Biological | 2 |
| Meningitec1 dose at 2,6 and 12 months | Biological | 3 |
Primary outcome
The pneumococcal and meningococcal responses achieved after the infant series
Time frame: 7 months
1 secondary outcome
The pneumococcal and meningococcal responses achieved after the toddler dose
Time frame: 13 months
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 27 Dec 2007.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevenar and Meningitec, Prevenar and Meningitec in people with Healthy, 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 27 Dec 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The pneumococcal and meningococcal responses achieved after the infant series (time frame: 7 months). 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 27 Dec 2007.